Trial · NCT00251303
Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
NCT00251303, Phase 2, Completed, National Institute of Mental Health (NIMH); results first posted 2014-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders. Trials, record NCT00251303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00251303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
- NCT number
- NCT00251303
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder, Autism, Asperger Disorder, Developmental Disorder
- Interventions
- Riluzole, Placebo
- First posted
- 2005-11-09
- Last updated
- 2014-07-15
- Results first posted
- 2014-07-15
- Limitations and caveats
Only treatment-refractory subjects were eligible for study participation. This may have decreased treatment response. Further, 98% were taking psychotropic drugs at baseline, which may have reduced between-group differences.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I) | 12 weeks | |
| Primary | Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS) | 12 weeks | CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I) | 12 weeks | participants | NUMBER | |
| PRIMARY | Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS) | 12 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I) | Riluzole | 3 | participants | ||
| Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I) | Placebo | 4 | participants | ||
| Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS) | Riluzole | 21.72 | Standard Deviation 6.43 | units on a scale | |
| Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS) | Placebo | 23.30 | Standard Deviation 4.64 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riluzole | 30 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Riluzole | 22 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | Riluzole | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | chest pain, hypotension, Tachycardia, EKG abnormality, and other cardiovascular | Cardiac disorders | Riluzole | 8 | 30 | 11 |
| other | chest pain, hypotension, Tachycardia, EKG abnormality, and other cardiovascular | Cardiac disorders | Placebo | 5 | 30 | 5 |
| other | earache, poor hearing, Tinnitus, and ear other | Ear and labyrinth disorders | Riluzole | 13 | 30 | 17 |
| other | earache, poor hearing, Tinnitus, and ear other | Ear and labyrinth disorders | Placebo | 11 | 30 | 13 |
| other | eye irritation, blurred vision, eye other | Eye disorders | Riluzole | 6 | 30 | 9 |
| other | eye irritation, blurred vision, eye other | Eye disorders | Placebo | 8 | 30 | 10 |
| other | fever | Infections and infestations | Riluzole | 6 | 30 | 6 |
| other | fever | Infections and infestations | Placebo | 7 | 30 | 7 |
| other | Accidental Injury | Injury, poisoning and procedural complications | Riluzole | 4 | 30 | 4 |
| other | Accidental Injury | Injury, poisoning and procedural complications | Placebo | 6 | 30 | 6 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riluzole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Riluzole | 27 | 30 |
| Total, other adverse events | Placebo | 29 | 30 |
| Total, serious adverse events | Riluzole | 1 | 30 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riluzole vs Placebo: Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I) | Trial comparisons |
| Riluzole vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00251303
GET https://conductscience.org/api/trials/v1/NCT00251303/events?page=2