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CompletedNCT00654927Updated Mar 2, 2012Results posted

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

A Phase 3 interventional study of Fampridine-SR b.i.d. (Twice Daily) in Multiple Sclerosis, sponsored by Acorda Therapeutics. Completed at 22 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-02.

Sponsored by Acorda Therapeutics · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
177
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • multiple sclerosis
  • MS
  • walking
  • leg strength
  • demyelination
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 177 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Acorda Therapeutics is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
177 participants (actual)

Interventions

  • DrugFampridine-SR b.i.d. (Twice Daily)

    Dosage form - tablets.

    Also known as: 4-aminopyridine

06

What researchers measure

Primary outcomes

  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.

    Time frame: over 7 years (2004-2011)

Secondary outcomes

  1. Timed 25 Foot Walk (T25FW)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: Screening visit, visit 6 and every 24 months thereafter

07

Results

Posted Feb 29, 2012

Participant flow

Participant flow — Overall Study
MilestoneFampridine-SR b.i.d. (Twice Daily)
Started177
Completed70
Not completed107

Outcome measures

PrimarySummary 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.

Time frame:
over 7 years (2004-2011)
Reported as:
Number · participants
Summary of Treatment Emergent Adverse Events (TEAE).
participantsFampridine-SR b.i.d.
Patients with Any AE176 ± 99.4
Patients with Any Serious AE65 ± 36.7
Patients with Any Possibly/Probably Related AE102 ± 41.8
Patients withdrawn due to AE34 ± 15.3
Patients who Died5 ± 2.3
Maximum Severity/Patients with Any TEAE -Mild10 ± 8.5
Maximum Severity/Patients with Any TEAE -Moderate66 ± 38.4
Maximum Severity/Patients with Any TEAE -Severe100 ± 47.5
SecondaryTimed 25 Foot Walk (T25FW)
Time frame:
Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit
Reported as:
Mean · feet/second
Timed 25 Foot Walk (T25FW)
feet/secondFampridine-SR b.i.d.
(N=153) Baseline1.87 ± 0.94
(N=1) >0-8 Weeks1.98 ± NA
(N=134) >8-16 Weeks2.09 ± 1.03
(N=141) >16-42 Weeks2.02 ± 1.04
(N=127) >42-68 Weeks1.82 ± 0.10
(N=111) >68-94 Weeks1.85 ± 1.05
(N=103) >94-120 Weeks1.77 ± 1.05
(N=92) >120-146 Weeks1.88 ± 0.10
(N=86) >146-172 Weeks1.84 ± 1.06
(N=76) >172-198 Weeks1.93 ± 1.34
(N=66) >198-224 Weeks1.82 ± 1.07
(N=56) >224-250 Weeks2.05 ± 1.16
(N=52) >250-276 Weeks2.03 ± 1.08
(N=54) >276-302 Weeks1.96 ± 1.09
(N=50) >302-328 Weeks1.98 ± 1.12
(N=10) >328-354 Weeks1.89 ± 1.57
SecondarySubject 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)

Time frame:
visit 1 and every clinic visit
Reported as:
Mean · units on a scale
Subject Global Impression (SGI)
units on a scaleFampridine-SR b.i.d.
(N=176) >0-8 Weeks4.79 ± 0.89
(N=168) >8-16 Weeks4.70 ± 1.31
(N=163) >16-42 Weeks4.71 ± 1.09
(N=148) >42-68 Weeks4.42 ± 1.09
(N=137)>68-94 Weeks4.67 ± 1.11
(N=128) >94-120 Weeks4.70 ± 1.17
(N=124) >120-146 Weeks4.73 ± 1.21
(N=114) >146-172 Weeks4.76 ± 1.29
(N=102) >172-198 Weeks4.84 ± 1.27
(N=91) >198-224 Weeks5.15 ± 1.15
(N=88) >224-250 Weeks5.10 ± 1.29
(N=84) >250-276 Weeks5.04 ± 1.16
(N=81) >276-302 Weeks4.91 ± 1.47
(N=74) >302-328 Weeks5.28 ± 1.21
(N=12) >328-354 Weeks5.08 ± 1.40
SecondaryClinician 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)

Time frame:
visit 1 and every clinic visit
Reported as:
Median · units on a scale
Clinician Global Impression of Change (CGIC)
units on a scaleFampridine-SR b.i.d.
(N=176) >0-8 Weeks3.37 ± 0.59
(N=168) >8-16 Weeks3.47 ± 0.97
(N=163) >16-42 Weeks3.60 ± 0.83
(N=148) >42-68 Weeks3.80 ± 0.89
(N=137) >68-94 Weeks3.83 ± 0.89
(N=128) >94-120 Weeks3.76 ± 0.89
(N=124) >120-146 Weeks3.70 ± 0.98
(N=116) >146-172 Weeks3.96 ± 1.05
(N=102) >172-198 Weeks3.89 ± 0.82
(N=92) >198-224 Weeks3.75 ± 1.02
(N=87) >224-250 Weeks3.79 ± 0.83
(N=83) >250-276 Weeks3.87 ± 1.11
(N=80) >276-302 Weeks4.29 ± 1.28
(N=73) >302-328 Weeks4.27 ± 1.34
(N=13) >328-354 Weeks3.81 ± 1.75
SecondaryExpanded 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

Time frame:
Screening visit, visit 6 and every 24 months thereafter
Reported as:
Mean · units on a scale
Expanded Disability Status Scale (EDSS)
units on a scaleFampridine-SR b.i.d.
(N=166) Baseline6.04 ± 1.09
(N=92) >8-16 Weeks6.14 ± 0.91
(N=114) >42-68 Weeks6.26 ± 1.20
(N=56) >146-172 Weeks6.03 ± 1.31

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fampridine-SR b.i.d. (Twice Daily)—65/177 (36.7%)176/177 (99.4%)
Most frequent serious events
Showing 10 of 88
Most frequent serious events
EventFampridine-SR b.i.d. (Twice Daily)
Multiple Sclerosis RelapseNervous system disorders12/177
Urinary Tract InfectionInfections and infestations7/177
Multiple SclerosisNervous system disorders5/177
PneumoniaInfections and infestations4/177
SepsisInfections and infestations4/177
CellulitisInfections and infestations3/177
FallInjury, poisoning and procedural complications3/177
Hip FractureInjury, poisoning and procedural complications3/177
Muscle SpasticityNervous system disorders3/177
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders3/177
Most frequent other events
Showing 10 of 64
Most frequent other events
EventFampridine-SR b.i.d. (Twice Daily)
Urinary Tract InfectionInfections and infestations84/177
FallInjury, poisoning and procedural complications75/177
InsomniaPsychiatric disorders52/177
Muscular WeaknessMusculoskeletal and connective tissue disorders45/177
Multiple Sclerosis RelapseNervous system disorders43/177
Muscle SpasticityNervous system disorders41/177
HeadacheNervous system disorders40/177
Oedema PeripheralGeneral disorders40/177
FatigueGeneral disorders39/177
ArthralgiaMusculoskeletal and connective tissue disorders34/177

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Fampridine-SR b.i.d. (Twice Daily)
<=18 years0
Between 18 and 65 years174
>=65 years3
Age Continuous
Age Continuous(years)Fampridine-SR b.i.d. (Twice Daily)
Mean51.9 ± 7.67
Sex: Female, Male
Sex: Female, Male(Participants)Fampridine-SR b.i.d. (Twice Daily)
Female111
Male66
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fampridine-SR b.i.d. (Twice Daily)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White171
More than one race4
Unknown or Not Reported0
08

Study locations

22 sites
  • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
    Phoenix, Arizona 85013, United States
  • USC, Keck School of Medicine Health Care Consultation Center
    Los Angeles, California 90033, United States
  • Shepherd Center
    Atlanta, Georgia 30309, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Maryland Center for MS
    Baltimore, Maryland 21201, United States
  • The Schapiro Center for MS
    Golden Valley, Minnesota 55422, United States
  • Washington University School of Medicine, Div. of Rehab/Neurology
    St. Louis, Missouri 63110, United States
  • Gimbel MS Center at Holy Name Hospital
    Teaneck, New Jersey 07666, United States
  • University of Mexico, MIND Imaging Center
    Albuquerque, New Mexico 87131, United States
  • Maimonides MS Care Center
    Brooklyn, New York 11219, United States
  • Corinne Goldsmith Dickinson Center for MS
    New York, New York 10029, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • SUNY Stony Brook
    Stony Brook, New York 11794, United States
  • CMC - Neuroscience & Spine Institute, Division of Neurology
    Charlotte, North Carolina 28207, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Ohio State University MS Center
    Columbus, Ohio 43221, United States
  • Oregon Health & Science University, MS Center of Oregon, UHS-42
    Portland, Oregon 97239, United States
  • Thomas Jefferson University Physicians
    Philadelphia, Pennsylvania 19107, United States
  • University of Texas-Houston
    Houston, Texas 77030, United States
  • MS Center at Evergreen
    Kirkland, Washington 98034, United States
  • Foothills Medical Center
    Calgary, Alberta T2N 2T9, Canada
  • St. Michael's Hospital
    Toronto, Ontario M5B 1WB, Canada
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References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00654927
Lead sponsor
Acorda Therapeutics
Responsible party
Sponsor
First posted
Apr 9, 2008
Start date
Nov 2003
Primary completion
Jan 2011
Completion
Apr 2011
Results posted
Feb 29, 2012
Last update
Mar 2, 2012

Study contacts

Bonnie Faust
study director · Acorda Therapeutics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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