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

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004939
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

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
Mayo Clinic
Investigators
Study Chair: Anthony J. Windebank Mayo Clinic
  More Information

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

Keywords provided by Office of Rare Diseases (ORD):
demyelinating neuropathy
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
3,4-diaminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014