Methylphenidate to Improve Balance and Walking in MS
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | July 2013 |
| End Date: | April 2016 |
Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the
treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis
tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS
to improve fatigue. It is proposed that methylphenidate may also improve imbalance and
walking deficits in MS by improving concentration and central integration, one of the primary
mechanisms thought to underlie imbalance and walking deficits in MS.
treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis
tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS
to improve fatigue. It is proposed that methylphenidate may also improve imbalance and
walking deficits in MS by improving concentration and central integration, one of the primary
mechanisms thought to underlie imbalance and walking deficits in MS.
The proposed pilot study will examine the effects of methylphenidate on imbalance and walking
in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive
either an escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each
day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose
escalation they will be instructed to discontinue use of the drug. The maximum safely
tolerated dose for each subject will be noted. Changes from baseline in subject's walking
speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each
dose.
in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive
either an escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each
day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose
escalation they will be instructed to discontinue use of the drug. The maximum safely
tolerated dose for each subject will be noted. Changes from baseline in subject's walking
speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each
dose.
Inclusion Criteria:
- Age 20-65
- Able to walk at least 100m without an aide or with unilateral assistance
- Poor static balance, specifically prolonged APR latencies (≥ 1 standard deviation (SD)
> mean for healthy people in this age range), OR
- Reduced balance-related activity (ABC scores ≤ 85%)
- Walking difficulties, specifically T25FW > 6 seconds, OR reduced self perceived
walking (MSWS-12 scores ≥ 50/60)
Exclusion Criteria:
- Currently taking methylphenidate, modafinil, or armodafinil.(any within the last 2
weeks)
- Cause(s) of imbalance other than MS
- Systolic pressure consistently greater than 150 mm Hg or diastolic pressure
consistently greater than 90 mm Hg
- Contraindications to methylphenidate (Anxiety, tension, agitation, thyrotoxicosis,
tachyarrhythmias, severe angina pectoris or glaucoma, hypersensitivity to
methylphenidate, motor tics or a family history or diagnosis of Tourette's syndrome,
seizures, severe or poorly controlled hypertension, treatment with monoamine oxidase
inhibitors currently or within the last 14 days, current use of guanethidine,
pressors, coumarin anticoagulants, anticonvulsants, phenylbutazone, or tricyclic
antidepressants, history of drug abuse or alcoholism)
- Pregnancy or breastfeeding
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