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/ / CNV1014802/202
A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia
PLS AVAILABLE
Study IdentifierCNV1014802/202
Clinicaltrials.gov
#NCT01540630
Details
Development Status
Discontinued
Study Type
Interventional
Results Available
Yes
Study Dates
03/2012 - 06/2014
Enrollment
67
Study Drug
Placebo, CNV1014802
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%.
Study Results
View and download the Results Summaries with the results of this completed study.
PDF
Plain Language Summary
PDF Document
View study results on registries