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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

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

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 History of Changes
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
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases
Demyelinating Diseases

Polyradiculoneuropathy
Peripheral Nervous System Diseases
Nervous System Diseases
Polyneuropathies
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009