Methylphenidate to Improve Balance and Walking in MS
What it found
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Methylphenidate | -0.7 change in seconds from basline | 0.5 (Standard Error) | 8 |
| Placebo | -1.3 change in seconds from basline | 0.2 (Standard Error) | 6 |
Methylphenidate
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Methylphenidate | 12 | 0 (0.0%) | 0 |
| Placebo | 12 | 0 (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 repairChange From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
6 weeks
Disability progressionWalking and mobilityChange From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks
6 weeks
Mood and sleepChange From Baseline in Modified Fatigue Index Scale Score at 6 Weeks
6 weeks
FatigueChange 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 testsChange 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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History
Started
Jul 2013
Main results due
Apr 2016
Finished
Apr 2016
Results posted
Apr 2018
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