A Phase 2 interventional study of Placebo and 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) in Multiple Sclerosis, sponsored by Acorda Therapeutics. Completed at 25 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-08-04.
Sponsored by Acorda Therapeutics · Phase 2, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 206 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.
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EXCLUSION CRITERIA:
Placebo control, twice a day (b.i.d.)
Drug: Placebo
10 milligram (mg) fampridine b.i.d.
Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)
15 mg fampridine b.i.d.
Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP)
20 mg fampridine b.i.d.
Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Placebo for 15 weeks
2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg)
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)
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)
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
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).
Time frame: Baseline (placebo run-in period); 12-week stable dose period
Patients with clinically definite MS were recruited at clinics within the US and Canada
| Milestone | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. |
|---|---|---|---|---|
| Started | 47 | 52 | 50 | 57 |
| Completed | 45 | 50 | 49 | 51 |
| Not completed | 2 | 2 | 1 | 6 |
| Withdrew: Adverse event | 1 | 0 | 1 | 5 |
| Withdrew: Non-compliance | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 | 0 |
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).
| percent change | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. |
|---|---|---|---|---|
| Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test | 1.2 ± 18.9 | 7.5 ± 22.1 | 9.7 ± 23.7 | 6.9 ± 18.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/47 (4.3%) | 38/47 (80.9%) |
| 10 mg Fampridine Twice a Day (b.i.d.) | — | 0/52 (0%) | 45/52 (86.5%) |
| 15 mg Fampridine b.i.d. | — | 4/50 (8%) | 47/50 (94%) |
| 20 mg Fampridine b.i.d. | — | 7/57 (12.3%) | 52/57 (91.2%) |
| Event | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. |
|---|---|---|---|---|
| Multiple SclerosisNervous system disorders | 0/47 | 0/52 | 2/50 | 4/57 |
| CellulitisInfections and infestations | 1/47 | 0/52 | 0/50 | 0/57 |
| Myocardial InfarctionCardiac disorders | 1/47 | 0/52 | 0/50 | 0/57 |
| Mental DisorderPsychiatric disorders | 0/47 | 0/52 | 1/50 | 0/57 |
| NauseaGastrointestinal disorders | 0/47 | 0/52 | 1/50 | 0/57 |
| VomitingGastrointestinal disorders | 0/47 | 0/52 | 1/50 | 0/57 |
| Complex Partial SeizuresNervous system disorders | 0/47 | 0/52 | 0/50 | 1/57 |
| ConvulsionNervous system disorders | 0/47 | 0/52 | 0/50 | 1/57 |
| Kidney InfectionInfections and infestations | 0/47 | 0/52 | 0/50 | 1/57 |
| Event | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. |
|---|---|---|---|---|
| DizzinessNervous system disorders | 5/47 | 2/52 | 10/50 | 7/57 |
| FallInjury, poisoning and procedural complications | 5/47 | 10/52 | 10/50 | 5/57 |
| InsomniaPsychiatric disorders | 4/47 | 5/52 | 10/50 | 7/57 |
| AstheniaGeneral disorders | 1/47 | 10/52 | 9/50 | 3/57 |
| Urinary Tract InfectionInfections and infestations | 2/47 | 6/52 | 5/50 | 9/57 |
| FatigueGeneral disorders | 5/47 | 8/52 | 7/50 | 5/57 |
| HeadacheNervous system disorders | 4/47 | 6/52 | 7/50 | 8/57 |
| ParaesthesiaNervous system disorders | 3/47 | 4/52 | 3/50 | 8/57 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 3/47 | 1/52 | 1/50 | 7/57 |
| Oedema PeripheralGeneral disorders | 3/47 | 4/52 | 6/50 | 3/57 |
| Age, Categorical(Participants) | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 50 | 49 | 55 | 199 |
| >=65 years | 2 | 2 | 1 | 2 | 7 |
| Age Continuous(years) | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. | Total |
|---|---|---|---|---|---|
| Mean | 49.0 ± 8.99 | 49.8 ± 8.34 | 47.7 ± 8.93 | 52.2 ± 8.33 | 49.8 ± 8.73 |
| Sex: Female, Male(Participants) | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. | Total |
|---|---|---|---|---|---|
| Female | 27 | 36 | 34 | 34 | 131 |
| Male | 20 | 16 | 16 | 23 | 75 |
| Region of Enrollment(participants) | Placebo | 10 mg Fampridine Twice a Day (b.i.d.) | 15 mg Fampridine b.i.d. | 20 mg Fampridine b.i.d. | Total |
|---|---|---|---|---|---|
| United States | 42 | 47 | 45 | 51 | 185 |
| Canada | 5 | 5 | 5 | 6 | 21 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Acorda Therapeutics