Multiple Sclerosis
Conditions
Keywords
Walking Ability
Brief summary
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Detailed description
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 subjects with MS.
Interventions
DRUGFampridine-SR
Tablets, 10 mg, twice daily, 14 weeks
DRUGPlacebo
sugar pill, twice a day (b.i.d.)
Sponsors
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of multiple sclerosis * Are able to walk with or without an assistive device
Exclusion criteria
* Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control * Participating in other investigational drug trials * A medical history or clinical findings that preclude entry into the study * A medication history that precludes entry into the study * Previously treated with 4-aminopyridine (4-AP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) | Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period. | Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits. |
Secondary
| Measure | Time frame |
|---|---|
| Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity | Days 14, 42, 70, 98 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo- Sugar Pill Placebo control group | 72 |
| Fampridine-SR 10 milligram (mg) tablet twice a day (b.i.d.) | 228 |
| Total | 300 |
Baseline characteristics
| Characteristic | Placebo- Sugar Pill | Fampridine-SR | Total |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 8.88 | 51.5 years STANDARD_DEVIATION 8.72 | 51.4 years STANDARD_DEVIATION 8.75 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black | 3 participants | 10 participants | 13 participants |
| Race/Ethnicity, Customized Caucasian | 67 participants | 211 participants | 278 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 43 Participants | 162 Participants | 205 Participants |
| Sex: Female, Male Male | 29 Participants | 66 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 72 | 191 / 228 |
| serious Total, serious adverse events | 0 / 72 | 16 / 228 |
Outcome results
Primary
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Time frame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo- Sugar Pill | Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) | 6 Participants |
| Fampridine-SR | Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) | 78 Participants |
Secondary
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Time frame: Days 14, 42, 70, 98