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

NCT00004802 | Completed Phase 3

• 2 other identifiers: 199/11958OSU-92H0173
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Paramyotonia Congenita

Keywords

neurologic and psychiatric disorders; periodic paralysis; rare disease

Interventions

dichlorphenamide DRUG

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Ohio State University: collaborator

MeSH Terms

Conditions

Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Myotonic Disorders; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Dichlorphenamide

Condition Hierarchy (Ancestors)

Paralyses, Familial Periodic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Jerry R. Mendell

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: June 1, 1992
• Last Updated: June 24, 2005

Record last verified: 1998-01