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PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations

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ClinicalTrials.gov Identifier: NCT03609619
Recruitment Status : Completed
First Posted : August 1, 2018
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Aevi Genomic Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: AEVI-001
Drug: Placebo
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AEVI-001 Placebo
Hide Arm/Group Description Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d. Oral doses of Placebo administered b.i.d.
Period Title: Overall Study
Started 54 55
Completed 44 49
Not Completed 10 6
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             1             2
Protocol Violation             5             0
Withdrawal by Subject             2             3
Lost to Follow-up             1             1
Arm/Group Title AEVI-001 Placebo Total
Hide Arm/Group Description Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d. Oral doses of Placebo administered b.i.d. Total of all reporting groups
Overall Number of Baseline Participants 53 55 108
Hide Baseline Analysis Population Description
ITT Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 55 participants 108 participants
10.4  (3.04) 10.3  (2.70) 10.4  (2.86)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
6 to 12 years
41
  77.4%
42
  76.4%
83
  76.9%
13 to 17 years
12
  22.6%
13
  23.6%
25
  23.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
Female
19
  35.8%
19
  34.5%
38
  35.2%
Male
34
  64.2%
36
  65.5%
70
  64.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
Hispanic or Latino
12
  22.6%
8
  14.5%
20
  18.5%
Not Hispanic or Latino
41
  77.4%
46
  83.6%
87
  80.6%
Unknown or Not Reported
0
   0.0%
1
   1.8%
1
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  11.3%
10
  18.2%
16
  14.8%
White
41
  77.4%
41
  74.5%
82
  75.9%
More than one race
4
   7.5%
1
   1.8%
5
   4.6%
Unknown or Not Reported
2
   3.8%
2
   3.6%
4
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 55 participants 108 participants
53 55 108
Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 53 participants 55 participants 108 participants
40.5  (8.78) 40.6  (8.71) 40.6  (8.70)
[1]
Measure Description:

The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = “Never or rarely” to 3 = “Very often”.

The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity.

1.Primary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score
Hide Description

The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often".

The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.

Time Frame Baseline to Visit 8 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AEVI-001 Placebo
Hide Arm/Group Description:
Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
Oral doses of Placebo administered b.i.d.
Overall Number of Participants Analyzed 52 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.04  (1.730) -10.38  (1.651)
2.Secondary Outcome
Title Clinical Global Impression – Global Improvement (CGI –I) Response
Hide Description

The CGI-I item is rated on a 7-point scale from 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", 7 = "Very much worse".

Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response

Time Frame Visit 3 to Visit 8 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AEVI-001 Placebo
Hide Arm/Group Description:
Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
Oral doses of Placebo administered b.i.d.
Overall Number of Participants Analyzed 52 54
Measure Type: Count of Participants
Unit of Measure: Participants
15
  28.8%
16
  29.6%
Time Frame 3 months, 13 days
Adverse Event Reporting Description All AEs are collected from the time of the informed consent is signed until the follow-up call is completed. This includes events occurring during the screening phase of the study, regardless of whether investigational product (IP) is administered. An AE will be considered treatment emergent if it occurs after the first dose of IP and within 3 days of a subjects last dose of IP.
 
Arm/Group Title AEVI-001 Placebo
Hide Arm/Group Description Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d. Oral doses of Placebo administered b.i.d.
All-Cause Mortality
AEVI-001 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)      0/55 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AEVI-001 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AEVI-001 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/53 (5.66%)      9/53 (16.98%)    
Investigations     
Weight increased * 1  1/53 (1.89%)  1 5/53 (9.43%)  5
Nervous system disorders     
Headache * 1  3/53 (5.66%)  6 4/53 (7.55%)  8
1
Term from vocabulary, MedDRA version 19.0
*
Indicates events were collected by non-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.
The information generated by this study is the property of Aevi Genomic Medicine, Inc. Publication or other public presentation of AEVI-001 data resulting from this study requires prior review and written approval of Aevi Genomic Medicine, Inc. Abstracts, manuscripts, and presentation materials should be provided to Aevi Genomic Medicine, Inc. for review at least 30 days prior to the relevant submission deadline.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Garry A. Neil, MD
Organization: Aevi Genomic Medicine
Phone: 610-254-4208
EMail: garry.neil@aevigenomics.com
Layout table for additonal information
Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT03609619     History of Changes
Other Study ID Numbers: AEVI-001-ADHD-202B
First Submitted: July 31, 2018
First Posted: August 1, 2018
Results First Submitted: June 25, 2019
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019