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Multiple SclerosisPhase 3NCT00654927

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

A Phase 3 study testing Fampridine-SR b.i.d. (Twice Daily) in people with Multiple Sclerosis, run by Acorda Therapeutics at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Fampridine-SR b.i.d. (Twice Daily)
Type of treatment
Pill or oral medicine
How many people
177 participants
Where
22 sitesin 2 countries
Study dates
Nov 2003to Apr 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must have been previously enrolled in an Acorda Therapeutics or an Elan Corporation sponsored study for multiple sclerosis and received either Fampridine or placebo.
  • The subject must have multiple sclerosis as determined by the Principal Investigator.
  • The subject, male or female, must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator.
  • The subject must be of adequate cognitive function, as judged by the Investigator.
  • Any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Who cannot join

  • The subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
  • The subject withdrew from a previous Fampridine study because of a Serious Adverse Event that was possibly, probably or definitely related to Fampridine.
  • The subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG.
  • The subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening Visit, as judged by the Investigator
  • The subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
  • The subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine tablet
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  • The subject has received an investigational drug, except for Fampridine- SR (or matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit; or the subject is scheduled to enroll in an investigational drug trial at any time during this study.
  • The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the Screening Visit.
  • The subject has had an onset of an MS exacerbation within 30 days prior to the Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a prior exacerbation episode.
  • The subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks.
  • The subject has a history of drug or alcohol abuse within the past year.

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States20 sites

  • University of Mexico, MIND Imaging Center

    Albuquerque, New Mexico, 87131

  • Shepherd Center

    Atlanta, Georgia, 30309

  • Maryland Center for MS

    Baltimore, Maryland, 21201

  • Maimonides MS Care Center

    Brooklyn, New York, 11219

  • CMC - Neuroscience & Spine Institute, Division of Neurology

    Charlotte, North Carolina, 28207

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University MS Center

    Columbus, Ohio, 43221

  • The Schapiro Center for MS

    Golden Valley, Minnesota, 55422

  • University of Texas-Houston

    Houston, Texas, 77030

  • MS Center at Evergreen

    Kirkland, Washington, 98034

  • USC, Keck School of Medicine Health Care Consultation Center

    Los Angeles, California, 90033

  • Corinne Goldsmith Dickinson Center for MS

    New York, New York, 10029

  • Thomas Jefferson University Physicians

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Oregon Health & Science University, MS Center of Oregon, UHS-42

    Portland, Oregon, 97239

  • University of Rochester

    Rochester, New York, 14642

  • Washington University School of Medicine, Div. of Rehab/Neurology

    St Louis, Missouri, 63110

  • SUNY Stony Brook

    Stony Brook, New York, 11794

  • Gimbel MS Center at Holy Name Hospital

    Teaneck, New Jersey, 07666

Other trials in United States

Canada2 sites

  • Foothills Medical Center

    Calgary, Alberta, T2N 2T9

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1WB

Other trials in Canada

About this study

Official title: Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.

Read the detailed description

Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this dose for the greater part of the duration of the 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 MS patients over a long period of time.

Being tested
Fampridine-SR b.i.d. (Twice Daily)
Keywords
multiple sclerosis, MS, walking, leg strength, demyelination
Medical subject headings
Multiple Sclerosis, Demyelinating Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fampridine-SR b.i.d. (Twice Daily)Drug

    Also called 4-aminopyridine

    Dosage form - tablets.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summary of Treatment Emergent Adverse Events (TEAE).

    All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.

    Measured: over 7 years (2004-2011)

Secondary outcomes (4)

  1. Timed 25 Foot Walk (T25FW)

    Measured: Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit

  2. Subject Global Impression (SGI)

    The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)

    Measured: visit 1 and every clinic visit

  3. Clinician Global Impression of Change (CGIC)

    The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)

    Measured: visit 1 and every clinic visit

  4. Expanded Disability Status Scale (EDSS)

    Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)

    *EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation

    Measured: Screening visit, visit 6 and every 24 months thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2008 (estimated)
  2. Study startNov 2003
  3. Primary completionJan 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00654927
Sponsor's protocol ID
MS-F202 EXT
Status last verified
Jan 2012
First submitted
4 Apr 2008
Last updated
2 Mar 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fampridine-SR b.i.d. (Twice Daily) in people with Multiple Sclerosis, run by Acorda Therapeutics at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Treatment Emergent Adverse Events (TEAE). (time frame: over 7 years (2004-2011)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00654927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.

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