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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Ohio State University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004802 |
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 III |
| Genetics Home Reference related topics: | hyperkalemic periodic paralysis hypokalemic periodic paralysis paramyotonia congenita potassium-aggravated myotonia |
| MedlinePlus related topics: | Paralysis |
| Drug Information available for: | Dichlorphenamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| 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.:
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:
--Patient Characteristics--
Hepatic: No hepatic disease
Renal:
Cardiovascular:
Pulmonary: No restrictive or obstructive lung disease
Other:
Contacts and Locations| National Center for Research Resources (NCRR) |
| Ohio State University |
| Study Chair: | Jerry R. Mendell | Ohio State University |
More Information
| Study ID Numbers: | 199/11958, OSU-92H0173 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004802 |
| Health Authority: | United States: Federal Government |
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