NCT01540630

A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia

A Phase IIa Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Safety and Efficacy of CNV1014802 in Patients With Trigeminal Neuralgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	CNV1014802	CNV1014802 150mg tid for 28 days. Dose may be increased to 350mg bid following interim evaluation of efficacy.
DRUG	Placebo	Double-blind placebo comparator for 28 days.

Timeline

• Start date: 2012-03-31
• Primary completion: 2014-03-31
• Completion: 2014-06-30
• First posted: 2012-02-29
• Last updated: 2019-01-10

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study