Trials / Completed
CompletedNCT02081027
Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 12 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).
Detailed description
A randomized, double blind, placebo-controlled, 12-week cross-over study (5-week treatment periods with 2-week washout) of adjunctive riluzole in 12 persons with ASD and DRI between the ages of 12 and 25 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Riluzole | |
| OTHER | placebo |
Timeline
- Start date
- 2013-09-19
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2014-03-07
- Last updated
- 2021-01-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02081027. Inclusion in this directory is not an endorsement.