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NCT Number: NCT00053417

Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

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 (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

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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 Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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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 assisted 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

Placebo

Drug

Placebo for 15 weeks

10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

Drug

2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg)

15 mg fampridine-SR (4-aminopyridine, 4-AP)

Drug

10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg)

20 mg fampridine-SR (4-aminopyridine, 4-AP)

Drug

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)

Primary outcomes

  1. Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test

    Time frame: Baseline (placebo run-in period); 12-week stable dose period

    The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study title

Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jan 30, 2003
Registry last updated
Aug 4, 2011

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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