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
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.
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.
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 →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.
Exclusion Criteria:
Dosage form - tablets.
Also known as: 4-aminopyridine
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)
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
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
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
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
| Milestone | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| Started | 177 |
| Completed | 70 |
| Not completed | 107 |
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.
| participants | Fampridine-SR b.i.d. |
|---|---|
| Patients with Any AE | 176 ± 99.4 |
| Patients with Any Serious AE | 65 ± 36.7 |
| Patients with Any Possibly/Probably Related AE | 102 ± 41.8 |
| Patients withdrawn due to AE | 34 ± 15.3 |
| Patients who Died | 5 ± 2.3 |
| Maximum Severity/Patients with Any TEAE -Mild | 10 ± 8.5 |
| Maximum Severity/Patients with Any TEAE -Moderate | 66 ± 38.4 |
| Maximum Severity/Patients with Any TEAE -Severe | 100 ± 47.5 |
| feet/second | Fampridine-SR b.i.d. |
|---|---|
| (N=153) Baseline | 1.87 ± 0.94 |
| (N=1) >0-8 Weeks | 1.98 ± NA |
| (N=134) >8-16 Weeks | 2.09 ± 1.03 |
| (N=141) >16-42 Weeks | 2.02 ± 1.04 |
| (N=127) >42-68 Weeks | 1.82 ± 0.10 |
| (N=111) >68-94 Weeks | 1.85 ± 1.05 |
| (N=103) >94-120 Weeks | 1.77 ± 1.05 |
| (N=92) >120-146 Weeks | 1.88 ± 0.10 |
| (N=86) >146-172 Weeks | 1.84 ± 1.06 |
| (N=76) >172-198 Weeks | 1.93 ± 1.34 |
| (N=66) >198-224 Weeks | 1.82 ± 1.07 |
| (N=56) >224-250 Weeks | 2.05 ± 1.16 |
| (N=52) >250-276 Weeks | 2.03 ± 1.08 |
| (N=54) >276-302 Weeks | 1.96 ± 1.09 |
| (N=50) >302-328 Weeks | 1.98 ± 1.12 |
| (N=10) >328-354 Weeks | 1.89 ± 1.57 |
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)
| units on a scale | Fampridine-SR b.i.d. |
|---|---|
| (N=176) >0-8 Weeks | 4.79 ± 0.89 |
| (N=168) >8-16 Weeks | 4.70 ± 1.31 |
| (N=163) >16-42 Weeks | 4.71 ± 1.09 |
| (N=148) >42-68 Weeks | 4.42 ± 1.09 |
| (N=137)>68-94 Weeks | 4.67 ± 1.11 |
| (N=128) >94-120 Weeks | 4.70 ± 1.17 |
| (N=124) >120-146 Weeks | 4.73 ± 1.21 |
| (N=114) >146-172 Weeks | 4.76 ± 1.29 |
| (N=102) >172-198 Weeks | 4.84 ± 1.27 |
| (N=91) >198-224 Weeks | 5.15 ± 1.15 |
| (N=88) >224-250 Weeks | 5.10 ± 1.29 |
| (N=84) >250-276 Weeks | 5.04 ± 1.16 |
| (N=81) >276-302 Weeks | 4.91 ± 1.47 |
| (N=74) >302-328 Weeks | 5.28 ± 1.21 |
| (N=12) >328-354 Weeks | 5.08 ± 1.40 |
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)
| units on a scale | Fampridine-SR b.i.d. |
|---|---|
| (N=176) >0-8 Weeks | 3.37 ± 0.59 |
| (N=168) >8-16 Weeks | 3.47 ± 0.97 |
| (N=163) >16-42 Weeks | 3.60 ± 0.83 |
| (N=148) >42-68 Weeks | 3.80 ± 0.89 |
| (N=137) >68-94 Weeks | 3.83 ± 0.89 |
| (N=128) >94-120 Weeks | 3.76 ± 0.89 |
| (N=124) >120-146 Weeks | 3.70 ± 0.98 |
| (N=116) >146-172 Weeks | 3.96 ± 1.05 |
| (N=102) >172-198 Weeks | 3.89 ± 0.82 |
| (N=92) >198-224 Weeks | 3.75 ± 1.02 |
| (N=87) >224-250 Weeks | 3.79 ± 0.83 |
| (N=83) >250-276 Weeks | 3.87 ± 1.11 |
| (N=80) >276-302 Weeks | 4.29 ± 1.28 |
| (N=73) >302-328 Weeks | 4.27 ± 1.34 |
| (N=13) >328-354 Weeks | 3.81 ± 1.75 |
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
| units on a scale | Fampridine-SR b.i.d. |
|---|---|
| (N=166) Baseline | 6.04 ± 1.09 |
| (N=92) >8-16 Weeks | 6.14 ± 0.91 |
| (N=114) >42-68 Weeks | 6.26 ± 1.20 |
| (N=56) >146-172 Weeks | 6.03 ± 1.31 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fampridine-SR b.i.d. (Twice Daily) | — | 65/177 (36.7%) | 176/177 (99.4%) |
| Event | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| Multiple Sclerosis RelapseNervous system disorders | 12/177 |
| Urinary Tract InfectionInfections and infestations | 7/177 |
| Multiple SclerosisNervous system disorders | 5/177 |
| PneumoniaInfections and infestations | 4/177 |
| SepsisInfections and infestations | 4/177 |
| CellulitisInfections and infestations | 3/177 |
| FallInjury, poisoning and procedural complications | 3/177 |
| Hip FractureInjury, poisoning and procedural complications | 3/177 |
| Muscle SpasticityNervous system disorders | 3/177 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 3/177 |
| Event | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| Urinary Tract InfectionInfections and infestations | 84/177 |
| FallInjury, poisoning and procedural complications | 75/177 |
| InsomniaPsychiatric disorders | 52/177 |
| Muscular WeaknessMusculoskeletal and connective tissue disorders | 45/177 |
| Multiple Sclerosis RelapseNervous system disorders | 43/177 |
| Muscle SpasticityNervous system disorders | 41/177 |
| HeadacheNervous system disorders | 40/177 |
| Oedema PeripheralGeneral disorders | 40/177 |
| FatigueGeneral disorders | 39/177 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 34/177 |
| Age, Categorical(Participants) | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 174 |
| >=65 years | 3 |
| Age Continuous(years) | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| Mean | 51.9 ± 7.67 |
| Sex: Female, Male(Participants) | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| Female | 111 |
| Male | 66 |
| Race (NIH/OMB)(Participants) | Fampridine-SR b.i.d. (Twice Daily) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 171 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
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Acorda Therapeutics