NCT00004802

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 10 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Paralysis, Hyperkalemic Periodic
• Hypokalemic Periodic Paralysis
• Paramyotonia Congenita

Interventions

Type	Name	Description
DRUG	dichlorphenamide

Timeline

• Start date: 1992-06-01
• First posted: 2000-02-25
• Last updated: 2005-06-24