Clinical Trial: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary:
OBJECTIVES:
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.
Detailed Summary:
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.
Sponsor: National Center for Research Resources (NCRR)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Office of Rare Diseases (ORD)
Dates:
Date Received: February 24, 2000
Date Started: June 1992
Date Completion:
Last Updated: June 23, 2005
Last Verified: January 1998