Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Par… (NCT00004802) | Clinical Trial Compass
CompletedPhase 3
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
64 participantsStarted 1992-06
Plain-language 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.
Who can participate
Age range10 Years – 75 Years
SexALL
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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
Trial details
NCT IDNCT00004802
SponsorNational Center for Research Resources (NCRR)