A Phase 3 interventional study of Fampridine-SR and Placebo in Spinal Cord Injury and Muscle Spasticity, sponsored by Acorda Therapeutics. Completed at 45 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Acorda Therapeutics · Phase 3, Interventional, and Treatment
Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 213 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity 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:
Drug: Fampridine-SR
Other: Placebo
25mg bid (twice daily)
Placebo
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.
Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
The target population consists of patients with chronic incomplete spinal cord injury (SCI) whose injury occurred at least 18 months prior to screening, and whose neurological status has been stable for at least 6 months.
| Milestone | Fampridine-SR 50mg/Day | Placebo |
|---|---|---|
| Started | 114 | 98 |
| Completed | 81 | 86 |
| Not completed | 33 | 12 |
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
| units on a scale | Fampridine-SR 50mg/Day | Placebo |
|---|---|---|
| Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity | -0.19 ± 0.039 | -0.15 ± 0.042 |
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.
| units on a scale | Fampridine-SR 50mg/Day | Placebo |
|---|---|---|
| Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment | -0.2 ± 0.08 | -0.1 ± 0.09 |
Collected over Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fampridine-SR 50mg/Day | — | 6/114 (5.3%) | 94/114 (82.5%) |
| Placebo | — | 6/98 (6.1%) | 84/98 (85.7%) |
| Event | Fampridine-SR 50mg/Day | Placebo |
|---|---|---|
| InfectionInfections and infestations | 0/114 | 1/98 |
| Reaction unevaluableGeneral disorders | 0/114 | 1/98 |
| SyncopeNervous system disorders | 0/114 | 1/98 |
| Gastrointestinal disorderGastrointestinal disorders | 0/114 | 1/98 |
| OsteomyelitisInfections and infestations | 0/114 | 1/98 |
| HypertoniaPsychiatric disorders | 0/114 | 1/98 |
| PyelonephritisInfections and infestations | 0/114 | 1/98 |
| Urinary tract infectionInfections and infestations | 0/114 | 1/98 |
| CellulitisInfections and infestations | 1/114 | 0/98 |
| AnxietyPsychiatric disorders | 1/114 | 0/98 |
| Event | Fampridine-SR 50mg/Day | Placebo |
|---|---|---|
| Urinary tract infectionInfections and infestations | 34/114 | 16/98 |
| HypertoniaNervous system disorders | 23/114 | 25/98 |
| Accidental injuryInjury, poisoning and procedural complications | 10/114 | 17/98 |
| PainGeneral disorders | 13/114 | 14/98 |
| DizzinessVascular disorders | 15/114 | 3/98 |
| InfectionInfections and infestations | 9/114 | 10/98 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/114 | 10/98 |
| ConstipationGastrointestinal disorders | 11/114 | 8/98 |
| HeadacheNervous system disorders | 10/114 | 8/98 |
| NauseaGastrointestinal disorders | 10/114 | 4/98 |
| Age, Continuous(years) | Fampridine-SR 50mg/Day | Placebo | Total |
|---|---|---|---|
| Mean | 41.6 ± 12.05 | 40.1 ± 13.10 | 40.9 ± 12.54 |
| Sex: Female, Male(Participants) | Fampridine-SR 50mg/Day | Placebo | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 100 | 85 | 185 |
| Race (NIH/OMB)(Participants) | Fampridine-SR 50mg/Day | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 12 | 30 |
| White | 94 | 81 | 175 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Acorda Therapeutics