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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

June 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004802 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Paralysis, Hyperkalemic Periodic
Hypokalemic Periodic Paralysis
Paramyotonia Congenita

Intervention ^ICMJE

Drug: dichlorphenamide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004802

Responsible Party

Study ID Numbers ^ICMJE

199/11958, OSU-92H0173

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Ohio State University

Investigators ^ICMJE

Study Chair:

Jerry R. Mendell

Ohio State University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 1998

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP