Multiple Sclerosis | Methylphenidate to Improve Balance and Walking in MS
Multiple Sclerosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MethylphenidateEscalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
Drug:PlaceboEscalating matched dose of placebo
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MethylphenidateIntervention: 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
PlaceboPlacebo pill, bid for 6 weeks
Start Date: July 2013
Completed Date: April 2016
Phase: Phase 2/Phase 3
Primary Outcome: Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
Secondary Outcome: Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
Study sponsors, principal investigator, and references
Principal Investigator: Michelle Cameron, PT, MD
Lead Sponsor: Oregon Health and Science University
Collaborator: Portland VA Medical Center