Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuropathic Pain
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 3 Sequences separated by 2 interim analyses evaluating safety and PK linearity. Sequence 1: 8 Patients randomized to placebo or NDMC 40mg/day (ratio 1:3) qd for 6 weeks. Sequence 2 will be initiated following the first interim analysis. Sequence 2: 8 Patients randomized to placebo or NDMC 60mg/day (ratio 1:3) qd for 6 weeks. Sequence 3 will be initiated following the second interim analysis. Otherwise Sequence 2 will be extended to a total of 30 placebo and 32 patients. Sequence 3: 60 Patients randomized to placebo or NDMC 60mg/day (ratio 28:32) bid for 6 weeks. Patients who do not tolerate 120mg/day will be authorized to step down to 60mg/day during the up titration period.Masking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04480164
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marie Besson, MD University Hospital, Geneva