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

Inclusion 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