Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Paralysis, Hyperkalemic Periodic Hypokalemic Periodic Paralysis Paramyotonia Congenita |
Drug: dichlorphenamide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 64 |
| Study Start Date: | June 1992 |
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| Ages Eligible for Study: | 10 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004802 History of Changes |
| Other Study ID Numbers: | 199/11958, OSU-92H0173 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
neurologic and psychiatric disorders periodic paralysis rare disease |
Additional relevant MeSH terms:
|
Paralyses, Familial Periodic Myotonic Disorders Paralysis, Hyperkalemic Periodic Hypokalemic Periodic Paralysis Paralysis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Metal Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Neurologic Manifestations Signs and Symptoms Dichlorphenamide Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013