Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
|ClinicalTrials.gov Identifier: NCT00004802|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Paralysis, Hyperkalemic Periodic Hypokalemic Periodic Paralysis Paramyotonia Congenita||Drug: dichlorphenamide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Study Start Date :||June 1992|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004802
|Study Chair:||Jerry R. Mendell||Ohio State University|