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

Primary Purpose

Paralysis, Hyperkalemic Periodic, Hypokalemic Periodic Paralysis, Paramyotonia Congenita

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dichlorphenamide
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralysis, Hyperkalemic Periodic focused on measuring neurologic and psychiatric disorders, periodic paralysis, rare disease

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Ohio State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004802
    Brief Title
    Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 1998
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1992 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Ohio State University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paralysis, Hyperkalemic Periodic, Hypokalemic Periodic Paralysis, Paramyotonia Congenita
    Keywords
    neurologic and psychiatric disorders, periodic paralysis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    64 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dichlorphenamide

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jerry R. Mendell
    Organizational Affiliation
    Ohio State University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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