CompletedPhase 2Phase 3MS (type not specified)NCT01896700

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Methylphenidate

    Dopamine transporter inhibitor|Norepinephrine transporter inhibitor

Placebo or sham

  • Placebo

Results by group

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

6 weeks

GroupValueIntervalNumber analysed
Methylphenidate-0.7 change in seconds from basline0.5 (Standard Error)8
Placebo-1.3 change in seconds from basline0.2 (Standard Error)6

Methylphenidate

-0.7

Placebo

-1.3

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Methylphenidate120 (0.0%)0
Placebo120 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    6 weeks

    Walking and mobility

Other measures (7)

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

    6 weeks

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

    6 weeks

    Disability progressionWalking and mobility
  • Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks

    6 weeks

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

    6 weeks

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

    6 weeks

  • Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks

    6 weeks

    Physical functionNerve conduction tests
  • Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks

    6 weeks

    Nerve conduction tests

Who could take part

MS (type not specified) · 20 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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Related trials

History

    1. Started

      Jul 2013

    2. Main results due

      Apr 2016

    3. Finished

      Apr 2016

    4. Results posted

      Apr 2018

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