Multiple Sclerosis
Conditions
Brief summary
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.
Detailed description
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks potassium channels on demyelinated neurons, allows normal electrical conduction. Dalfampridine has recently been found to be associated with improvements in visual function, strength, ambulation, fatigue, and endurance in individuals with MS. Although this medication has a widespread effect, its influence on upper extremity function has never been investigated in a double blind randomized case control study. Following the fact that during the disease course, approximately 3 out of 4 multiple sclerosis patients encounter upper limb dysfunction the primary objective of this study will be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity function in patients with MS.
Interventions
DRUGSustained-release oral dalfampridine
One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
DRUGPlacebo
Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The patient must have the ability to understand the purpose and risks of the study provide a signed and dated informed consent and authorize confidential health information to be examined in accordance with national and local subject privacy regulations. 2. The patient must have been diagnosed with clinically definite MS, at the time of informed consent. 3. The patient must be between 18-70 years of age, inclusive, at the time of informed consent. 4. The patient must have scored between 50 and 90 on the upper limb Motricity Index test, at the time of informed consent. This test evaluates strength during three essential movements (pinch grasp, elbow flexion and shoulder abduction). The selected score range criteria determine patients who suffer a moderate decline in function abilities of the upper limb.
Exclusion criteria
1. Onset of multiple sclerosis exacerbation within 60 days of screening. 2. History of seizures or evidence of epileptic form activity found on a screened electroencephalogram. 3. Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nine-Hole Peg Test | Changes in the Nine-Hole Peg Test from Baseline to end of Second week | The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block test | Changes in the Box and Block Test from Baseline to end of Second week | The box and blocks test (BBT) examines manual dexterity |
| Isometric grip force and motor fatigue | Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week | Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction |
| Sensory evaluation | Changes in the Sensory evaluation Test from Baseline to end of Second week | The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments |
| Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH) | Changes in the DASH Test from Baseline to end of Second week | The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5 |
Countries
Israel
Contacts
Primary ContactShlomo Noy, MD, PhD
Backup ContactAlon Kalron, PhD
Outcome results
None listed