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Trial record 19 of 56 for:    insys

Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02318602
Recruitment Status : Completed
First Posted : December 17, 2014
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Seizures
Intervention Drug: Cannabidiol Oral Solution
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Period Title: Overall Study
Started 9 26 17
Completed 8 22 15
Not Completed 1 4 2
Reason Not Completed
Adverse Event             0             1             1
Withdrawal by Subject             0             3             0
Death             1             0             0
Guardian decision to withdraw             0             0             1
Arm/Group Title Infants Children Adolescents Total
Hide Arm/Group Description

Participants 1 to <2 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Total of all reporting groups
Overall Number of Baseline Participants 9 26 17 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 26 participants 17 participants 52 participants
1.00  (0.00) 6.7  (2.84) 13.9  (1.58) 8.1  (5.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 26 participants 17 participants 52 participants
Female
4
  44.4%
11
  42.3%
9
  52.9%
24
  46.2%
Male
5
  55.6%
15
  57.7%
8
  47.1%
28
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 26 participants 17 participants 52 participants
Hispanic or Latino
2
  22.2%
2
   7.7%
1
   5.9%
5
   9.6%
Not Hispanic or Latino
7
  77.8%
24
  92.3%
16
  94.1%
47
  90.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 26 participants 17 participants 52 participants
American Indian or Alaska Native
0
   0.0%
1
   3.8%
1
   5.9%
2
   3.8%
Asian
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.9%
Black or African American
0
   0.0%
2
   7.7%
0
   0.0%
2
   3.8%
White
8
  88.9%
19
  73.1%
16
  94.1%
43
  82.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  11.1%
2
   7.7%
0
   0.0%
3
   5.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 26 participants 17 participants 52 participants
9 26 17 52
1.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment.
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents All Participants
Hide Arm/Group Description:

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

All participants who participated in the study.
Overall Number of Participants Analyzed 9 26 17 52
Measure Type: Number
Unit of Measure: Percentage of participants
88.9 92.3 88.2 90.4
2.Primary Outcome
Title Percentage of Participants With Serious Adverse Events
Hide Description A serious adverse event is any untoward medical occurrence ( whether considered to be related to investigational product or not) that at any dose results in death, is life threatening, requires inpatient hospitalization, results in disability/incapacity, is a congenital abnormality/ birth defect, or medically significant as determined by an investigator.
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents All Participants
Hide Arm/Group Description:

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

All participants who participated in the study.
Overall Number of Participants Analyzed 9 26 17 52
Measure Type: Number
Unit of Measure: Percentage of participants
77.8 38.5 0 32.7
3.Primary Outcome
Title Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values
Hide Description Laboratory values include chemistry and hematology, and urinary analysis.
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 9 26 17
Measure Type: Number
Unit of Measure: Percentage of participants
Hematology 0 0 0
Blood Chemistry 0 0 0
Urinalysis 0 0 0
4.Primary Outcome
Title Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Hide Description [Not Specified]
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to<2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 9 26 17
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0
5.Primary Outcome
Title Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description [Not Specified]
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to <2 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 9 26 17
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0
6.Primary Outcome
Title Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite
Hide Description [Not Specified]
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient data was collected to perform study analysis.
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to<2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Vineland Adaptive Behavior Scales (VABS)
Hide Description

The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.

The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement.

The VABS will be completed for all participants.

Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Population (SAF) consisted of all participants in the enrolled population group (ENR) who received at least one dose of the investigational product.
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 9 26 17
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Communication: Expressive (Day 1) Number Analyzed 9 participants 26 participants 17 participants
6.8  (7.34) 40.4  (37.53) 40.3  (42.76)
Communication: Expressive (Week 36) Number Analyzed 7 participants 17 participants 12 participants
8.3  (9.03) 51.7  (41.79) 36.0  (41.63)
Communication: Expressive (Week 48) Number Analyzed 8 participants 25 participants 13 participants
9.9  (9.30) 48.6  (38.91) 34.3  (40.62)
Communication: Receptive (Day 1) Number Analyzed 9 participants 26 participants 17 participants
6.0  (7.35) 17.4  (13.10) 18.8  (14.88)
Communication: Receptive (Week 36) Number Analyzed 7 participants 17 participants 12 participants
8.6  (7.23) 21.1  (13.15) 15.7  (15.95)
Communication: Receptive (Week 48) Number Analyzed 8 participants 25 participants 13 participants
11.5  (8.73) 20.6  (13.15) 16.8  (14.62)
Communication: Written (Day 1) Number Analyzed 4 participants 24 participants 17 participants
0.0  (0.00) 9.2  (13.47) 12.9  (17.09)
Communication: Written (Week 36) Number Analyzed 3 participants 16 participants 12 participants
1.3  (2.31) 11.8  (15.98) 12.8  (17.33)
Communication: Written (Week 48) Number Analyzed 7 participants 25 participants 13 participants
0.0  (0.00) 10.8  (13.88) 10.5  (17.15)
Daily Living Skills: Community (Day 1) Number Analyzed 9 participants 26 participants 16 participants
0.4  (1.33) 13.8  (18.62) 19.1  (26.03)
Daily Living Skills: Community (Week 36) Number Analyzed 7 participants 17 participants 12 participants
0.6  (1.51) 17.8  (19.99) 18.8  (26.58)
Daily Living Skills: Community (Week 48) Number Analyzed 8 participants 25 participants 13 participants
1.0  (2.14) 16.6  (21.29) 18.8  (29.07)
Daily Living Skills: Domestic (Day 1) Number Analyzed 9 participants 26 participants 17 participants
0.4  (1.33) 9.1  (11.85) 9.7  (15.70)
Daily Living Skills: Domestic (Week 36) Number Analyzed 7 participants 17 participants 12 participants
0.9  (2.27) 9.6  (12.45) 10.7  (16.42)
Daily Living Skills: Domestic (Week 48) Number Analyzed 8 participants 24 participants 13 participants
0.8  (2.12) 9.9  (13.43) 9.2  (15.71)
Daily Living Skills: Personal (Day 1) Number Analyzed 9 participants 26 participants 16 participants
3.6  (6.65) 31.7  (29.37) 28.6  (27.98)
Daily Living Skills: Personal (Week 36) Number Analyzed 7 participants 17 participants 12 participants
5.0  (8.93) 39.2  (29.64) 26.2  (29.19)
Daily Living Skills: Personal (Week 48) Number Analyzed 8 participants 25 participants 13 participants
5.6  (8.09) 36.2  (30.66) 25.4  (29.78)
Socialization: Coping Skills (Day 1) Number Analyzed 9 participants 26 participants 16 participants
2.1  (2.67) 14.6  (18.34) 16.9  (20.33)
Socialization: Coping Skills (Week 36) Number Analyzed 7 participants 17 participants 12 participants
2.6  (3.99) 16.2  (16.37) 16.7  (20.81)
Socialization: Coping Skills (Week 48) Number Analyzed 8 participants 25 participants 13 participants
3.1  (4.32) 15.0  (17.08) 15.9  (20.63)
Socialization: Interpersonal Relationships (Day 1) Number Analyzed 9 participants 26 participants 17 participants
9.4  (10.14) 28.9  (22.93) 31.1  (25.41)
Socialization: Interpersonal Relationships (Wk 36) Number Analyzed 7 participants 17 participants 12 participants
11.9  (10.67) 35.7  (21.85) 25.8  (22.75)
Socialization: Interpersonal Relationships (Wk 48) Number Analyzed 8 participants 25 participants 13 participants
14.0  (12.62) 33.3  (22.67) 26.7  (24.35)
Socialization: Play and Leisure Time (Day 1) Number Analyzed 9 participants 26 participants 16 participants
5.3  (9.53) 20.5  (20.11) 19.7  (20.62)
Socialization: Play and Leisure Time (Week 36) Number Analyzed 7 participants 17 participants 12 participants
6.6  (10.55) 24.4  (19.77) 19.6  (22.71)
Socialization: Play and Leisure Time (Week 48) Number Analyzed 8 participants 24 participants 13 participants
6.4  (10.16) 21.8  (18.96) 17.9  (22.66)
Motor Skills: Fine (Day 1) Number Analyzed 9 participants 26 participants 17 participants
4.2  (9.72) 26.7  (27.29) 23.1  (26.20)
Motor Skills: Fine (Week 36) Number Analyzed 7 participants 17 participants 11 participants
5.1  (12.29) 33.6  (27.38) 20.9  (24.32)
Motor Skills: Fine (Week 48) Number Analyzed 8 participants 25 participants 13 participants
6.0  (8.67) 32.2  (27.56) 24.0  (25.21)
Motor Skills: Gross (Day 1) Number Analyzed 9 participants 26 participants 17 participants
8.0  (18.45) 42.5  (31.90) 31.0  (29.57)
Motor Skills: Gross (Week 36) Number Analyzed 7 participants 17 participants 11 participants
11.0  (22.96) 46.5  (32.43) 31.9  (26.74)
Motor Skills: Gross (Week 48) Number Analyzed 8 participants 25 participants 13 participants
12.8  (22.42) 46.6  (32.44) 33.3  (29.03)
Maladaptive Behavior Index: Externalizing (Day 1) Number Analyzed 0 participants 26 participants 17 participants
3.5  (3.51) 3.5  (3.10)
Maladaptive Behavior Index: Externalizing (Wk 36) Number Analyzed 2 participants 17 participants 12 participants
0.0  (0.00) 4.5  (4.81) 3.1  (3.42)
Maladaptive Behavior Index: Externalizing (Wk 48) Number Analyzed 4 participants 25 participants 13 participants
0.0  (0.00) 4.4  (4.10) 2.2  (2.95)
Maladaptive Behavior Index: Internalizing (Day 1) Number Analyzed 0 participants 26 participants 16 participants
5.2  (4.01) 3.6  (3.24)
Maladaptive Behavior Index: Internalizing (Wk 36) Number Analyzed 2 participants 17 participants 12 participants
0.0  (0.00) 5.4  (3.06) 3.7  (3.63)
Maladaptive Behavior Index: Internalizing (Wk 48) Number Analyzed 4 participants 25 participants 13 participants
1.0  (2.00) 5.3  (4.10) 3.6  (3.62)
Maladaptive Behavior Index: MBI Score (Day 1) Number Analyzed 0 participants 26 participants 16 participants
14.8  (7.53) 13.0  (8.75)
Maladaptive Behavior Index: MBI Score (Week 36) Number Analyzed 2 participants 17 participants 12 participants
0.0  (0.00) 16.6  (8.65) 10.8  (9.04)
Maladaptive Behavior Index: MBI Score (Week 48) Number Analyzed 4 participants 24 participants 13 participants
1.0  (2.00) 16.1  (9.17) 10.2  (8.47)
Maladaptive Behavior Index: Other (Day 1) Number Analyzed 0 participants 26 participants 17 participants
6.2  (4.17) 6.2  (4.76)
Maladaptive Behavior Index: Other (Week 36) Number Analyzed 2 participants 17 participants 12 participants
0.0  (0.00) 6.7  (4.01) 4.1  (3.60)
Maladaptive Behavior Index: Other (Week 48) Number Analyzed 4 participants 24 participants 13 participants
0.0  (0.00) 6.5  (3.30) 4.3  (3.88)
8.Secondary Outcome
Title Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description For subjects 7 years of developmental age or older, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered to access suicidality. The appropriate adult version will be used in subjects 12 years of (developmental) age and older. The investigator will determine the participant's developmental age.
Time Frame Up to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description:

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Overall Number of Participants Analyzed 9 26 17
Measure Type: Count of Participants
Unit of Measure: Participants
Suicidal Ideation
0
   0.0%
0
   0.0%
0
   0.0%
Suicidal Behavior
0
   0.0%
0
   0.0%
0
   0.0%
9.Other Pre-specified Outcome
Title Clinical Global Impression of Severity (CGI-S)
Hide Description

The severity of the participant's illness is rated on a seven-point scale, where 1=normal, not at all ill, and 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The score reflects the average severity level across the seven days.

The CGI-S will be completed for all participants, regardless of chronological and developmental age.

Time Frame through study completion, up to 48 weeks or marketing approval, whichever is earlier
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Impact of Pediatric Epilepsy Scale (IPES)
Hide Description

The IPES assesses the impact on academic achievement, participation in activities, health, relationships with family and with peers and siblings, social activities, self-esteem, and the caregiver’s hopes for their child’s future. It takes about 3 minutes for the parent to complete. Each of the 11 items is given a severity score of 0 (not at all) to 3 (a lot). The higher the score, the higher is the impact of epilepsy on that item. The highest total score possible is 33 (range 0–33).

The Impact of Pediatric Epilepsy Scale (IPES) is validated for subjects who are 2 to 16 years of age. Due to developmental delay characteristic of the study population, subjects through 18 years of chronological age will complete the IPES. Subjects over 18 years of chronological age will not complete the IPES.

Time Frame through study completion, up to 48 weeks or marketing approval, whichever is earlier
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Clinical Global Impression of Improvement (CGI-I)
Hide Description

The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment.

The CGI-I will be completed for all participants, regardless of chronological and developmental age.

Time Frame through study completion, up to 48 weeks or marketing approval, whichever is earlier
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Change From Baseline in Frequency of Seizures as a Measure of Seizure Control
Hide Description [Not Specified]
Time Frame through study completion, up to 48 weeks or marketing approval, whichever is earlier
Outcome Measure Data Not Reported
Time Frame Up to Week 50
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infants Children Adolescents
Hide Arm/Group Description

Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator’s discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.

All-Cause Mortality
Infants Children Adolescents
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   0/26 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Infants Children Adolescents
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/9 (77.78%)   10/26 (38.46%)   0/17 (0.00%) 
Gastrointestinal disorders       
Constipation  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
General disorders       
Multi-organ failure  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Infections and infestations       
Adenovirus infection  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Pneumonia  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Pneumonia viral  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Pulmonary sepsis  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Pyelonephritis  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Respiratory syncytial virus infection  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Respiratory tract infection viral  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Sepsis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Tracheobronchitis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Skull fracture  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Nervous system disorders       
Seizure  1  5/9 (55.56%)  5/26 (19.23%)  0/17 (0.00%) 
Status epilepticus  1  2/9 (22.22%)  0/26 (0.00%)  0/17 (0.00%) 
Ataxia  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Change in seizure presentation  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Psychiatric disorders       
Mental status changes  1  1/9 (11.11%)  1/26 (3.85%)  0/17 (0.00%) 
Aggression  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Anxiety  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory distress  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory failure  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Status asthmaticus  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Social circumstances       
Physical assault  1  0/9 (0.00%)  1/26 (3.85%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infants Children Adolescents
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/9 (88.89%)   24/26 (92.31%)   15/17 (88.24%) 
Blood and lymphatic system disorders       
Anaemia  1  0/9 (0.00%)  6/26 (23.08%)  1/17 (5.88%) 
Microcytic anaemia  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Cardiac disorders       
Bradycardia  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Pulmonary valve incompetence  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Tachycardia  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Tricuspid valve incompetence  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Congenital, familial and genetic disorders       
Atrial septal defect  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Cryptorchism  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/9 (0.00%)  5/26 (19.23%)  2/17 (11.76%) 
Constipation  1  0/9 (0.00%)  4/26 (15.38%)  1/17 (5.88%) 
Haematochezia  1  1/9 (11.11%)  1/26 (3.85%)  0/17 (0.00%) 
Vomiting  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Inguinal hernia  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Haematemesis  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
General disorders       
Pyrexia  1  3/9 (33.33%)  4/26 (15.38%)  0/17 (0.00%) 
Device expulsion  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Device failure  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Multi-organ failure  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  1  1/9 (11.11%)  6/26 (23.08%)  1/17 (5.88%) 
Nasopharyngitis  1  1/9 (11.11%)  3/26 (11.54%)  1/17 (5.88%) 
Otitis media  1  0/9 (0.00%)  5/26 (19.23%)  0/17 (0.00%) 
Influenza  1  1/9 (11.11%)  3/26 (11.54%)  0/17 (0.00%) 
Urinary tract infection  1  0/9 (0.00%)  1/26 (3.85%)  2/17 (11.76%) 
Escherichia urinary tract infection  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Pharyngitis streptococcal  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Pneumonia  1  0/9 (0.00%)  1/26 (3.85%)  1/17 (5.88%) 
Conjunctivitis  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Ear infection  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Folliculitis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Mycoplasma infection  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Otitis media acute  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Pharyngitis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory tract infection  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory tract infection viral  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Sepsis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Tracheobronchitis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Vestibulitis  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Viral upper respiratory tract infection  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications       
Skin abrasion  1  0/9 (0.00%)  3/26 (11.54%)  0/17 (0.00%) 
Ligament sprain  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Accidental overdose  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Ankle fracture  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Investigations       
Weight increased  1  0/9 (0.00%)  4/26 (15.38%)  0/17 (0.00%) 
Human rhinovirus test positive  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Weight decreased  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/9 (0.00%)  3/26 (11.54%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Musculoskeletal stiffness  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Nervous system disorders       
Seizure  1  4/9 (44.44%)  9/26 (34.62%)  3/17 (17.65%) 
Somnolence  1  2/9 (22.22%)  4/26 (15.38%)  1/17 (5.88%) 
Ataxia  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Epilepsy  1  1/9 (11.11%)  1/26 (3.85%)  0/17 (0.00%) 
Status epilepticus  1  2/9 (22.22%)  0/26 (0.00%)  0/17 (0.00%) 
Change in seizure presentation  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Clumsiness  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Dizziness  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Fontanelle bulging  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Partial seizures  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Postictal paralysis  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Psychiatric disorders       
Aggression  1  0/9 (0.00%)  5/26 (19.23%)  0/17 (0.00%) 
Insomnia  1  1/9 (11.11%)  2/26 (7.69%)  1/17 (5.88%) 
Irritability  1  1/9 (11.11%)  0/26 (0.00%)  1/17 (5.88%) 
Mental status changes  1  1/9 (11.11%)  1/26 (3.85%)  0/17 (0.00%) 
Agitation  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Flat affect  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Head banging  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Restlessness  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/9 (0.00%)  3/26 (11.54%)  1/17 (5.88%) 
Asthma  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Sleep apnea syndrome  1  1/9 (11.11%)  0/26 (0.00%)  1/17 (5.88%) 
Adenoidal hypertrophy  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Apnoea  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Nasal congestion  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Hypoxia  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Pneumonia aspiration  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory distress  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory failure  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Respiratory tract congestion  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
Sinus congestion  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Status asthmaticus  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Upper respiratory tract inflammation  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Wheezing  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  0/9 (0.00%)  2/26 (7.69%)  0/17 (0.00%) 
Cold sweat  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Decubitus ulcer  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Dermatitis diaper  1  1/9 (11.11%)  0/26 (0.00%)  0/17 (0.00%) 
Rash  1  0/9 (0.00%)  0/26 (0.00%)  1/17 (5.88%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Clinical Development
Organization: Insys Therapeutics, Inc.
Phone: 480-500-3105
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02318602     History of Changes
Other Study ID Numbers: INS011-14-030
First Submitted: December 12, 2014
First Posted: December 17, 2014
Results First Submitted: June 26, 2018
Results First Posted: July 25, 2018
Last Update Posted: July 25, 2018