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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Polyneuropathies

ClinicalTrials.gov processed this record on October 22, 2014