Methylphenidate to Improve Balance and Walking in MS

NCT01896700 | Completed Phase 2 Results DMC

• 1 other identifier: 3055
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; postural balance; walking

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks

  The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.

  6 weeks

Secondary Outcomes (7)

• Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks

  6 weeks

• Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks

  6 weeks

• Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks

  6 weeks

• Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks

  6 weeks

• Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks

  6 weeks

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Placebo pill, bid for 6 weeks

Drug: Placebo

Interventions

Methylphenidate DRUG

Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each

Also known as: Ritalin

Methylphenidate

Placebo DRUG

Escalating matched dose of placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Portland VA Medical Center: collaborator

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrea Hildebrand
• Organization: Portland VA Health Care System

hildeand@ohsu.edu

503-220-8262

Study Officials

• Michelle Cameron, PT, MD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Assistant Professor

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 5, 2018
• Results First Posted: April 5, 2018

Record last verified: 2018-03

Locations

US (1)