NCT00494507

Hyper- and Hypokalemic Periodic Paralysis Study

Dichlorphenamide vs. Placebo for Periodic Paralysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperkalemic Periodic Paralysis
• Hypokalemic Periodic Paralysis

Interventions

Type	Name	Description
DRUG	Dichlorphenamide (double-blind)	50mg tablet; maximum dosage 400mg/day
DRUG	Placebo (double-blind)	Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
DRUG	Dichlorphenamide (open-label)	50mg tablet; maximum dosage 400mg/day

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2007-06-29
• Last updated: 2017-06-14
• Results posted: 2014-05-30

Locations

12 sites across 3 countries: United States, Italy, United Kingdom