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Methylphenidate to Improve Balance and Walking in MS

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Methylphenidate (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Michelle Cameron, PT, MD, Principal Investigator, Affiliation: Portland VA Medical Center

Overall contact:
Andrea Hildebrand, BA, Phone: 503-220-8262, Ext: 52016, Email: andrea.hildebrand@va.gov

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.

Clinical Details

Official title: Methylphenidate to Improve Balance and Walking in MS

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Timed Up and Go time (TUG time)

Secondary outcome:

Automatic Postural Response (APR) Latency (in sec)

Timed 25 Foot Walk (T25FW in secs)

Pittsburgh Sleep Quality Assessment Questionnaire score

Modified Fatigue Index Scale score

Vestibular-Ocular Reflex time (in secs)

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

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Andrea Hildebrand, BA, Phone: 503-220-8262, Ext: 52016, Email: andrea.hildebrand@va.gov

Portland VA Medical Center, Portland, Oregon 97239, United States; Recruiting
Andrea Hildebrand, BA, Phone: 503-220-8262, Ext: 52016, Email: andrea.hildebrand@va.gov
Michelle H Cameron, MD, PT, Principal Investigator
Additional Information

Starting date: July 2013
Last updated: October 20, 2014

Page last updated: August 23, 2015

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