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

Paramyotonia Congenita Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004802
• Other study ID #: 199/11958
• Secondary ID: OSU-92H0173
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: June 1992

Study information

• Verified date: January 1998
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 75 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Hypokalemic periodic paralysis Typical clinical profile Normal serum thyroxine Hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member

Periodic paralysis associated with sodium channel 17q alpha-subunit, e.g.:

• Hyperkalemic periodic paralysis with or without myotonia

• Paramyotonia congenita with periodic paralysis

Distinct, regular episodes of weakness at least once a week and no more than 3 times a day

No history of worsening symptoms with carbonic anhydrase inhibitor

No history of life-threatening weakness episodes prior to treatment

No atypical periodic paralysis without demonstrable 17q alpha-subunit defect

--Prior/Concurrent Therapy--

No requirement for the following agents, unless for periodic paralysis:

• Diuretics

• Antiepileptics

• Antiarrhythmics

• Magnesium supplements

• Steroids

• Calcium supplements

• Beta-blockers

• Potassium supplements

• Calcium channel blockers

--Patient Characteristics--

Hepatic: No hepatic disease

Renal:

• No renal failure

• No nephrolithiasis

Cardiovascular:

• No heart disease

• No cardiac arrhythmia

Pulmonary: No restrictive or obstructive lung disease

Other:

• No active thyroid disease

• No pregnant women

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• dichlorphenamide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Ohio State University