Trial Outcomes & Findings for Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism (NCT NCT00211757)
NCT ID: NCT00211757
Last Updated: 2024-10-28
Results Overview
The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domains. The CGI-I irritability took into consideration the scores from the ABC-Irritability subscale, the OAS-M aggression and irritability subscales and information from open-ended questioning related to the degree of interference, nature, and range of behavioral problems at school and at home
COMPLETED
PHASE2
27 participants
Baseline to end of study (week 15)
2024-10-28
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalproex Sodium
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalproex Sodium
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalporex Sodium
n=16 Participants
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Diagnosis
Autistic Disorder
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Diagnosis
Asperger's Syndrome
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (week 15)The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domains. The CGI-I irritability took into consideration the scores from the ABC-Irritability subscale, the OAS-M aggression and irritability subscales and information from open-ended questioning related to the degree of interference, nature, and range of behavioral problems at school and at home
Outcome measures
| Measure |
Placebo
n=11 Participants
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalproex Sodium
n=16 Participants
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
|---|---|---|
|
Number of Participants Reporting Improvement on the Clinical Global Impression
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Study (week 15)The Aberrant Behavior Checklist is designed to objectively identify five behavior sub scales through observation by the primary caregiver: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. The ABC was filled out by parents on a scale from 0-3 for each category. (0 being not a problem, 3 being severe problem). Scores from all sub scales were added (scoring 0-45 for Irritability subscale, 0-48 for Lethargy subscale, 0-21 for stereotypy scale, 0-48 for hyperactivity sub-scale, and 0-12 for inappropriate speech sub-scale) to obtain an overall score with a an overall scoring range of 0-174. Higher scores were indicative of worsening symptoms.
Outcome measures
| Measure |
Placebo
n=11 Participants
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalproex Sodium
n=16 Participants
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
|---|---|---|
|
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores
baseline
|
22 score on a scale
Standard Deviation 7.81
|
20.3 score on a scale
Standard Deviation 7.36
|
|
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores
Week 15
|
14.5 score on a scale
Standard Deviation 6.67
|
17.7 score on a scale
Standard Deviation 7.94
|
Adverse Events
Placebo
Divalproex Sodium
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Placebo: Placebo comparator.
|
Divalproex Sodium
n=16 participants at risk
Subjects will receive the study drug, divalproex sodium.
Divalproex sodium: Study drug.
|
|---|---|---|
|
General disorders
Insomnia
|
18.2%
2/11 • 6 weeks on treatment
|
12.5%
2/16 • 6 weeks on treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • 6 weeks on treatment
|
12.5%
2/16 • 6 weeks on treatment
|
|
Metabolism and nutrition disorders
Weight gian
|
9.1%
1/11 • 6 weeks on treatment
|
6.2%
1/16 • 6 weeks on treatment
|
|
General disorders
headache
|
0.00%
0/11 • 6 weeks on treatment
|
6.2%
1/16 • 6 weeks on treatment
|
|
General disorders
polyuria
|
0.00%
0/11 • 6 weeks on treatment
|
12.5%
2/16 • 6 weeks on treatment
|
|
General disorders
agitation
|
9.1%
1/11 • 6 weeks on treatment
|
12.5%
2/16 • 6 weeks on treatment
|
|
Immune system disorders
Infection
|
27.3%
3/11 • 6 weeks on treatment
|
12.5%
2/16 • 6 weeks on treatment
|
|
General disorders
Hypersomnolence
|
27.3%
3/11 • 6 weeks on treatment
|
0.00%
0/16 • 6 weeks on treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place