Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Swedo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00251303
First received: November 9, 2005
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: May 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obsessive-Compulsive Disorder
Autism Spectrum Disorder
Autism
Asperger Disorder
Developmental Disorder
Interventions: Drug: Riluzole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had to be symptomatic for at least 6 weeks, with a score of at least 20 CY-BOCS; had to have had at least one standard-of-care treatment for childhood OCD for adequate periods of time; had to have been stable for at least 6 weeks on any medicine; had to meet entrance criteria at a screening and 2 weeks later.

Reporting Groups
  Description
Riluzole Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
Placebo Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.

Participant Flow:   Overall Study
    Riluzole     Placebo  
STARTED     30 [1]   30  
COMPLETED     22     29  
NOT COMPLETED     8     1  
[1] 78 subjects signed any consent. 60 started drug (30 riluzole & 30 placebo).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These data apply only to double-blind phase.

Reporting Groups
  Description
Riluzole

In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.

Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent.

Placebo

Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.

Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study.

Total Total of all reporting groups

Baseline Measures
    Riluzole     Placebo     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     30     30     60  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.78  ± 2.10     14.17  ± 2.58     14.47  ± 2.35  
Gender  
[units: participants]
     
Female     8     8     16  
Male     22     22     44  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  



  Outcome Measures
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1.  Primary:   Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)   [ Time Frame: 12 weeks ]

2.  Primary:   Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)   [ Time Frame: at 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Susan E. Swedo
Organization: National Institute of Mental Health, Pediatrics and Developmental Neuroscience Branch
phone: 301-496-5323
e-mail: swedos@mail.nih.gov


Publications:

Publications automatically indexed to this study:

Responsible Party: Susan Swedo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00251303     History of Changes
Other Study ID Numbers: 050225, 05-M-0225
Study First Received: November 9, 2005
Results First Received: May 16, 2013
Last Updated: July 14, 2014
Health Authority: United States: Federal Government