NCT01896700

Methylphenidate to Improve Balance and Walking in MS

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Methylphenidate	Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
DRUG	Placebo	Escalating matched dose of placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-07-11
• Last updated: 2018-04-05
• Results posted: 2018-04-05

Locations

1 site across 1 country: United States