Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Paramyotonia Congenita
Intervention: dichlorphenamide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Jerry R. Mendell, Study Chair, Affiliation: Ohio State University
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 10 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 1992
Last updated: June 23, 2005
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