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

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004802
Collaborator
Ohio State University (Other)
64
Enrollment

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. 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.
Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 1992

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)
    • Ohio State University

    Investigators

    • Study Chair: Jerry R. Mendell, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004802
    Other Study ID Numbers:
    • 199/11958
    • OSU-92H0173
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 1998
    Keywords provided by , ,
    neurologic and psychiatric disorders
    periodic paralysis
    rare disease
    Additional relevant MeSH terms:
    Myotonic Disorders
    Hypokalemic Periodic Paralysis
    Paralysis, Hyperkalemic Periodic
    Paralysis
    Dichlorphenamide

    Study Results

    No Results Posted as of Jun 24, 2005