Clinical trial NCT01896700: Methylphenidate to Improve Balance and Walking in MS
Official title: Methylphenidate to Improve Balance and Walking in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
postural balance
walking
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2013-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Michelle Cameron, PT, MD
role: PRINCIPAL_INVESTIGATOR
References: