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Vigabatrin for Treatment of Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00611130
First received: January 28, 2008
Last updated: March 14, 2016
Last verified: March 2016
Results First Received: April 13, 2012  
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
Condition: Cocaine Dependence
Interventions: Drug: vigabatrin
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
01/08-01/09 at 11 US research trial sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After Informed Consent obtained, subjects entered a 2-4 week Screening/Baseline Phase to determine whether all Inclusion/Exclusion Criteria were met. Randomization strata included gender, primary method of cocaine administration (snort or intravenous/smoke) & use in last 30 days (≤18 days or >18 days)

Reporting Groups
  Description
CPP-109 Vigabatrin CPP-109 tablets, 500 mg. 3 Tablets bid.
Placebo Matching Placebo Tablets. 3 tablets bid.

Participant Flow:   Overall Study
    CPP-109 Vigabatrin   Placebo
STARTED   92   94 
Completed 12 Week Treatment Phase   61   64 
COMPLETED   43   47 
NOT COMPLETED   49   47 
Lost to Follow-up                25                29 
Protocol noncompliance                7                6 
Withdrawal by Subject                6                5 
Unspecified                5                4 
Incarceration                3                2 
Administrative                1                1 
Adverse Event                1                0 
Death                1                0 



  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.
No text entered.

Reporting Groups
  Description
CPP-109 Vigabatrin CPP-109 tablets, 500 mg. 3 Tablets bid.
Placebo Matching Placebo Tablets. 3 tablets bid.
Total Total of all reporting groups

Baseline Measures
   CPP-109 Vigabatrin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   94   186 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.6  (7.62)   45.0  (8.33)   44.8  (7.92) 
Gender 
[Units: Participants]
     
Female   32   30   62 
Male   60   64   124 
Region of Enrollment 
[Units: Participants]
     
United States   92   94   186 


  Outcome Measures
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1.  Primary:   Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.   [ Time Frame: Week 13 ]

2.  Post-Hoc:   Medication Compliance   [ Time Frame: Week 2, 4, 6 & 9-11 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information