Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Mayo Clinic
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004939

Purpose

OBJECTIVES:

I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

Condition	Intervention	Phase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Drug: ,4-diaminopyridine	Phase III

Drug Information available for: 3,4-Diaminopyridine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	34
Study Start Date:	August 1996
Estimated Study Completion Date:	August 1996

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in immunosuppressive dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004939

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Mayo Clinic

Investigators

Study Chair:

Anthony J. Windebank

Mayo Clinic

More Information

Publications:

Russell JW, Windebank AJ, Harper CM Jr. Treatment of stable chronic demyelinating polyneuropathy with 3,4-diaminopyridine. Mayo Clin Proc. 1995 Jun;70(6):532-9.

Study ID Numbers:	199/11963, MAYOC-585
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004939
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

demyelinating neuropathy
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Neuromuscular Diseases
Demyelinating Diseases
Mental Disorders
Polyradiculoneuropathy

Peripheral Nervous System Diseases
3,4-diaminopyridine
Rare Diseases
Polyneuropathies
Demyelinating diseases
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009