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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Ohio State University
• Treatments: Dichlorphenamide

Criteria

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