Methylphenidate to Improve Balance and Walking in MS

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Methylphenidate

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01896700

3055

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Methylphenidate

Experimental group

Description:

Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day. Other name: Ritalin

Treatment:

Drug: Methylphenidate

Placebo

Placebo Comparator group

Description:

Placebo pill, bid for 6 weeks

Treatment:

Drug: Placebo