Hypokalemic Periodic Paralysis Clinical Trial
Official title:
Dichlorphenamide vs. Placebo for Periodic Paralysis
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.
Periodic paralysis is a relatively rare, life-long disorder characterized by intermittent
bouts of paralysis, progressive weakness, and diminished quality of life. Two drugs,
acetazolamide (ACZ) and dichlorphenamide, have been prescribed to treat the disorder,
however, dichlorphenamide is no longer available.
In this multi-center, parallel, randomized trial researchers will compare the effects of
dichlorphenamide vs. placebo in patients with hyperkalemic (HYP) and hypokalemic (HOP)
periodic paralysis.
The trial consists of two 9-week studies—one study will enroll persons with hyperkalemic
periodic paralysis and the other study will enroll persons with hypokalemic periodic
paralysis. Participants will be randomly assigned to one of two treatment groups:
dichlorphenamide or placebo (an inactive substance). During the studies, participants will
be asked to keep a daily diary to record the time, length, and severity of each episode of
weakness (attack). The study coordinator will contact participants weekly to review the
diary information.
The 9-week phase will be followed by a 1-year open-label dichlorphenamide extension without
placebo to determine the long-term effects of dichlorphenamide on the course of the disease
and on inter-attack weakness.
Duration of the trial for participants is approximately 65 weeks, including a screening
phase to determine eligibility, the first 9-week treatment phase, and the one-year
open-label extension phase.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00004802 -
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
|
Phase 3 | |
| Terminated |
NCT02582476 -
Bumetanide in Hypokalaemic Periodic Paralysis
|
Phase 2 |