Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.
|Paralysis, Hyperkalemic Periodic Hypokalemic Periodic Paralysis Paramyotonia Congenita||Drug: dichlorphenamide||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||June 1992|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and diagnosis.
The weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover.
Patients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then cross to the alternate treatment. Patients on DCP at baseline continue on the same dose; those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the ACZ dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004802
|Study Chair:||Jerry R. Mendell||Ohio State University|