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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004939
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Drug: ,4-diaminopyridine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1996
Study Completion Date : August 1996

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004939

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Mayo Clinic
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Study Chair: Anthony J. Windebank Mayo Clinic

Layout table for additonal information Identifier: NCT00004939     History of Changes
Other Study ID Numbers: 199/11963
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001
Keywords provided by Office of Rare Diseases (ORD):
demyelinating neuropathy
neurologic and psychiatric disorders
rare disease
Additional relevant MeSH terms:
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases