Phase 3
N=24
Methylphenidate to Improve Balance and Walking in MS
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01896700 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks — -0.7; -1.3 change in seconds from basline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methylphenidate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks |
-0.7; -1.3 | — |
| SECONDARY Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks |
-9.2; -5.3 | — |
| SECONDARY Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks |
-0.3; -0.6 | — |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks |
0.3; -0.3 | — |
| SECONDARY Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks |
-3.8; -9.8 | — |
| SECONDARY Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks |
-0.0107; -0.0229; -0.0061; -0.283; -0.0151; 0.0871 | — |
| SECONDARY Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks |
0.9927; -1.7291; -0.0572; -6.5209; 2.5833; -5.2852 | — |
| SECONDARY Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks |
2.2790; 1.9535; 1.8914; -1.4716; 0.9449; -0.3342 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01896700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.