Completed

Dichlorphenamide for Periodic Paralyses and Sodium Channel Disorders

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What is being tested

dichlorphenamide

Drug
Who is being recruted

Metabolic Diseases+18

+ Metabolism, Inborn Errors

+ Metal Metabolism, Inborn Errors

From 10 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 1992
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00004802
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMuscular DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesParalyses, Familial PeriodicPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesGenetic Diseases, InbornMental DisordersNeurologic ManifestationsParalysis, Hyperkalemic PeriodicHypokalemic Periodic ParalysisMyotonic DisordersRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers