Trial record 2 of 2 for:    Narcolepsy | Open Studies | NIH, U.S. Fed

Methylphenidate to Improve Balance and Walking in MS

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Oregon Health and Science University
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01896700
First received: July 8, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Methylphenidate (Ritalin)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Methylphenidate to Improve Balance and Walking in MS

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Timed Up and Go time (TUG time) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at each dose. Changes in TUG times will be calculated by comparing the TUG time at each time point (i.e. dose) after intervention (T+2weeks, T+4weeks and T+6weeks) with the baseline TUG time. Mean changes at each time point will be compared for active and placebo treated subjects using t-tests.


Secondary Outcome Measures:
  • Automatic Postural Response (APR) Latency (in sec) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Mean changes in APR latency at each time point will be compared for active and placebo treated subjects using t-tests.

  • Timed 25 Foot Walk (T25FW in secs) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Mean changes in Timed 25 Foot Walk (T25FW) at each time point will be compared for active and placebo treated subjects using t-tests.

  • Pittsburgh Sleep Quality Assessment Questionnaire score [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at each time point will be compared for active and placebo treated subjects using t-tests.

  • Modified Fatigue Index Scale score [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Mean changes in the score attached on the Modified Fatigue Index Scale at each time point will be compared for active and placebo treated subjects using t-tests.

  • Vestibular-Ocular Reflex time (in secs) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Mean changes in saccade latency and peak velocity at each time point will be compared for active and placebo treated subjects using t-tests.


Estimated Enrollment: 24
Study Start Date: July 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate

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 (Ritalin)
Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
Other Name: Ritalin
Placebo Comparator: Placebo
Placebo pill, bid for 6 weeks
Drug: Placebo
Escalating matched dose of placebo

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

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20-59
  • 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, armodafinil, or dalfampridine (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896700

Contacts
Contact: Ashley Downs, BS 503-220-8262 ext 52016 Ashley.Downs@va.gov

Locations
United States, Oregon
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Ashley Downs, B.S.    503-220-8262 ext 52016    Ashley.Downs@va.gov   
Contact: Melissa Tee, M.A.    503-494-3549    teem@ohsu.edu   
Principal Investigator: Michelle H Cameron, MD, PT         
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
  More Information

No publications provided

Responsible Party: Michelle Cameron, Neurologist, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01896700     History of Changes
Other Study ID Numbers: 3055
Study First Received: July 8, 2013
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Multiple sclerosis
postural balance
walking

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014