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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004802
Enrollment
64
Registered
2000-02-25
Start date
1992-06-30
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypokalemic Periodic Paralysis, Paralysis, Hyperkalemic Periodic, Paramyotonia Congenita

Keywords

neurologic and psychiatric disorders, periodic paralysis, rare disease

Brief 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.

Interventions

DRUGdichlorphenamide

Sponsors

Ohio State University
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026