A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in
      patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an
      initial open-label phase.

      Patients will participate in an initial open-label treatment period of 21 days of CNV1014802
      150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg
      tid or placebo.

      Following an interim analysis after 10 evaluable patients have completed the open-label
      phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the
      trial if the responder rate is less than 60%.
    

Detailed description: 
      In order to be randomised and enter the double-blind placebo controlled phase of the study,
      patients must satisfy at least one of the following criteria:

        -  30% or more decrease in number of paroxysms (either spontaneous, evoked, or both)

        -  30% reduction in the severity of pain experienced during the paroxysm (either
           spontaneous, evoked or both)

        -  A Patient Global Improvement of Change rating of much improved/very much improved The
           response will be compared with the baseline recordings of pain made in the 7 day run-in
           period. If a patient meets one of these criteria they are termed a responder, and will
           be eligible to be randomized into the double-blind treatment phase.

      During the double-blind randomised phase, patients will be evaluated to determine if they
      meet the failure criteria at each clinic visit which will occur every 7 days in the
      double-blind treatment period. The number of failures on CNV1014802 versus number of failures
      on placebo during the double-blind treatment period will be the primary outcome of the study.

      Patients will be classified as a treatment failure if they meet one of the following
      criteria:

        -  50% increase in the frequency of paroxysms compared to the final 7 days of the
           open-label period

        -  50% increase in the severity of pain experienced in the paroxysms compared to the final
           7 days of the open-label period

        -  A Patient Global Improvement of Change rating of much worse/very much worse

        -  The patient discontinues the study due to 'Lack of Efficacy'

        -  The patient discontinues due to an adverse reaction or poor tolerability considered to
           be related to study medication

      This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been
      acquired by Biogen.
    

Intervention name(s): CNV1014802; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CNV1014802 150mg tid for 28 days. Dose may be increased to 350mg bid following interim evaluation of efficacy.; Double-blind placebo comparator for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment