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Trial record 5 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

Lurasidone Pediatric Autism Study

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: NCT01911442
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Lurasidone 20 mg daily
Drug: Lurasidone
Drug: Placebo
Enrollment 150
Recruitment Details Participants were recruited from 46 centers in the United States between August 2013 and October 2014
Pre-assignment Details Participants were screened and washed out up to 21 days.
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description Subjects received 20 mg/day from Day 1 to Week 6 Visit Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive). Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Period Title: Overall Study
Started 49 51 50
Completed 43 47 38
Not Completed 6 4 12
Reason Not Completed
Adverse Event             2             2             4
Lack of Efficacy             1             1             1
Lost to Follow-up             2             0             1
Withdrawal by Subject             1             0             6
Mother's Work Schedule             0             1             0
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo Total
Hide Arm/Group Description Subject received placebo to match lurasidone from Day 1 to Week 6 Visit Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive). Subject received placebo to match lurasidone from Day 1 to Week 6 Visit Total of all reporting groups
Overall Number of Baseline Participants 49 51 49 149
Hide Baseline Analysis Population Description
The disposition table for the overall study used all subjects randomized. The baseline characteristics summary used safety population. 1 subject in placebo group did not take any study medication, and was removed from the safety population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 49 participants 149 participants
<=18 years
49
 100.0%
51
 100.0%
49
 100.0%
149
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 49 participants 149 participants
Female
10
  20.4%
8
  15.7%
9
  18.4%
27
  18.1%
Male
39
  79.6%
43
  84.3%
40
  81.6%
122
  81.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 49 participants 149 participants
Hispanic or Latino
11
  22.4%
7
  13.7%
7
  14.3%
25
  16.8%
Not Hispanic or Latino
38
  77.6%
44
  86.3%
42
  85.7%
124
  83.2%
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 49 participants 51 participants 49 participants 149 participants
American Indian or Alaska Native
1
   2.0%
1
   2.0%
0
   0.0%
2
   1.3%
Asian
0
   0.0%
1
   2.0%
1
   2.0%
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  20.4%
9
  17.6%
5
  10.2%
24
  16.1%
White
35
  71.4%
38
  74.5%
42
  85.7%
115
  77.2%
More than one race
0
   0.0%
1
   2.0%
1
   2.0%
2
   1.3%
Unknown or Not Reported
3
   6.1%
1
   2.0%
0
   0.0%
4
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 51 participants 49 participants 149 participants
49 51 49 149
1.Primary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6
Hide Description The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description:
Subjects received 20 mg/day from Day 1 to Week 6 Visit
Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Overall Number of Participants Analyzed 48 51 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.8  (1.5) 9.4  (1.43) 7.5  (1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 20 mg Once Daily, Placebo
Comments LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5463
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-5.6 to 3.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurasidone 60 mg Once Daily, Placebo
Comments LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3592
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-6.1 to 2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
Hide Description The Clinical Global Impression – Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description:
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Overall Number of Participants Analyzed 48 51 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.1  (0.17) -1.0  (0.16) -0.7  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 20 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1755
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurasidone 60 mg Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2402
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6
Hide Description The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description:
Subjects received 20 mg/day from Day 1 to Week 6 Visit
Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Overall Number of Participants Analyzed 48 51 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.7  (1.50) -6.6  (1.43) -7.1  (1.52)
4.Secondary Outcome
Title Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)
Hide Description CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description:
Subjects received 20 mg/day from Day 1 to Week 6 Visit
Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Overall Number of Participants Analyzed 48 51 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.46) -1.0  (0.44) -1.2  (0.49)
5.Secondary Outcome
Title Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)
Hide Description CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description:
Subjects received 20 mg/day from Day 1 to Week 6 Visit
Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
Overall Number of Participants Analyzed 48 51 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.49  (0.292) -1.66  (0.274) -1.35  (0.300)
6.Secondary Outcome
Title Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6
Hide Description [Not Specified]
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - the current data presented is at week 6.
Arm/Group Title Lurasidone 20 mg Lurasidone 60 mg Placebo
Hide Arm/Group Description:

Lurasidone 20 mg once daily

Lurasidone 20 mg daily: Lurasidone 20 mg once daily

Lurasidone 60 mg once daily

Lurasidone: Lurasidone 60 mg once daily

Placebo once daily

Placebo: Placebo

Overall Number of Participants Analyzed 43 47 38
Measure Type: Number
Unit of Measure: percentage of subjects
17 17 14
7.Secondary Outcome
Title Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.
Hide Description [Not Specified]
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lurasidone 20 mg Lurasidone 60 mg Placebo
Hide Arm/Group Description:

Lurasidone 20 mg once daily

Lurasidone 20 mg daily: Lurasidone 20 mg once daily

Lurasidone 60 mg once daily

Lurasidone: Lurasidone 60 mg once daily

Placebo once daily

Placebo: Placebo

Overall Number of Participants Analyzed 43 47 38
Measure Type: Number
Unit of Measure: percentage of subjects
25 26 23
Time Frame Adverse event data were collected as spontaneous reports at all visits
Adverse Event Reporting Description Participant flow module presents all subjects randomized. The summary of AEs is based on safety population. As explained earlier, there were 49 placebo subjects included in the safety population.
 
Arm/Group Title Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Hide Arm/Group Description Subjects received 20 mg/day from Day 1 to Week 6 Visit Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive). Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
All-Cause Mortality
Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/49 (6.12%)      2/51 (3.92%)      0/49 (0.00%)    
General disorders       
Appendicitis   0/49 (0.00%)  0 1/51 (1.96%)  1 0/49 (0.00%)  0
Irritability   1/49 (2.04%)  1 0/51 (0.00%)  0 0/49 (0.00%)  0
Injury, poisoning and procedural complications       
Torus Fracture   1/49 (2.04%)  1 1/51 (1.96%)  1 0/49 (0.00%)  0
Upper Limb Fracture   1/49 (2.04%)  1 1/51 (1.96%)  1 0/49 (0.00%)  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 4%
Lurasidone 20 mg Once Daily Lurasidone 60 mg Once Daily Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/49 (67.35%)      38/51 (74.51%)      28/49 (57.14%)    
Gastrointestinal disorders       
Vomiting   4/49 (8.16%)  4 14/51 (27.45%)  17 2/49 (4.08%)  2
Diarrhoea   1/49 (2.04%)  1 4/51 (7.84%)  4 4/49 (8.16%)  4
Nausea   2/49 (4.08%)  2 3/51 (5.88%)  6 0/49 (0.00%)  0
Constipation   0/49 (0.00%)  0 3/51 (5.88%)  3 1/49 (2.04%)  1
Gastritis   2/49 (4.08%)  2 0/51 (0.00%)  0 0/49 (0.00%)  0
Abdominal Discomfort   2/49 (4.08%)  2 0/51 (0.00%)  0 0/49 (0.00%)  0
General disorders       
Fatigue   1/49 (2.04%)  1 4/51 (7.84%)  5 1/49 (2.04%)  1
Pyrexia   2/49 (4.08%)  2 1/51 (1.96%)  1 0/49 (0.00%)  0
Irritability   2/49 (4.08%)  2 0/51 (0.00%)  0 2/49 (4.08%)  2
Infections and infestations       
Nasopharynigitis   5/49 (10.20%)  5 3/51 (5.88%)  4 0/49 (0.00%)  0
Gastroenteritis Viral   1/49 (2.04%)  1 1/51 (1.96%)  1 2/49 (4.08%)  2
Rhinitis   2/49 (4.08%)  2 0/51 (0.00%)  0 0/49 (0.00%)  0
Injury, poisoning and procedural complications       
Laceration   2/49 (4.08%)  2 1/51 (1.96%)  1 1/49 (2.04%)  1
Investigations       
Weight Increased   1/49 (2.04%)  1 4/51 (7.84%)  4 1/49 (2.04%)  1
Metabolism and nutrition disorders       
Increased Appetite   0/49 (0.00%)  0 1/51 (1.96%)  2 3/49 (6.12%)  3
Nervous system disorders       
Somnolence   3/49 (6.12%)  4 9/51 (17.65%)  10 2/49 (4.08%)  2
Akathisia   3/49 (6.12%)  5 3/51 (5.88%)  6 0/49 (0.00%)  0
Headache   2/49 (4.08%)  2 3/51 (5.88%)  3 3/49 (6.12%)  4
Psychomotor Hyperactivity   2/49 (4.08%)  2 2/51 (3.92%)  2 1/49 (2.04%)  2
Sedation   3/49 (6.12%)  3 1/51 (1.96%)  1 1/49 (2.04%)  1
Lethargy   2/49 (4.08%)  2 0/51 (0.00%)  0 0/49 (0.00%)  0
Disturbance in Attention   0/49 (0.00%)  0 0/51 (0.00%)  0 2/49 (4.08%)  2
Psychiatric disorders       
Aggression   2/49 (4.08%)  3 1/51 (1.96%)  1 0/49 (0.00%)  0
Insomnia   1/49 (2.04%)  1 1/51 (1.96%)  1 5/49 (10.20%)  5
Anxiety   0/49 (0.00%)  0 0/51 (0.00%)  0 2/49 (4.08%)  2
Renal and urinary disorders       
Enuresis   0/49 (0.00%)  0 0/51 (0.00%)  0 2/49 (4.08%)  2
Respiratory, thoracic and mediastinal disorders       
Cough   2/49 (4.08%)  2 3/51 (5.88%)  3 2/49 (4.08%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.

In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.

Results Point of Contact
Name/Title: 1-866-503-6351
Organization: Sunovion
Phone: 1-866-503-6351
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01911442     History of Changes
Other Study ID Numbers: D1050325
First Submitted: July 22, 2013
First Posted: July 30, 2013
Results First Submitted: November 8, 2015
Results First Posted: February 25, 2016
Last Update Posted: February 25, 2016