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Completed

NCT Number: NCT00127530

Study of Oral Fampridine-SR in Multiple Sclerosis

To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

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About this study

Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a confirmed diagnosis of multiple sclerosis
  • Are able to walk with or without an assistive device

Exclusion criteria

  • Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
  • Participating in other investigational drug trials
  • A medical history or clinical findings that preclude entry into the study
  • A medication history that precludes entry into the study
  • Previously treated with 4-aminopyridine (4-AP)

Treatment and study plan

Fampridine-SR

Drug

Tablets, 10 mg, twice daily, 14 weeks

Other names: Sustained release 4-aminopyridine, 4-AP

Placebo

Drug

sugar pill, twice a day (b.i.d.)

Primary outcomes

  1. Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)

    Time frame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.

    Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.

Secondary outcomes

  1. Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity

    Time frame: Days 14, 42, 70, 98

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study title

Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 8, 2005
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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