A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia
Status:
Completed
Trial end date:
2014-06-30
Target enrollment:
Participant gender:
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%.