Methylphenidate to Improve Balance and Walking in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01896700
• Date of registration: 08/07/2013
• Prospective Registration: No
• Primary sponsor: Oregon Health and Science University
• Public title: Methylphenidate to Improve Balance and Walking in MS
• Scientific title: Methylphenidate to Improve Balance and Walking in MS
• Date of first enrolment: July 2013
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01896700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Michelle Cameron, PT, MD
• Affiliation: Portland VA Medical Center

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Methylphenidate

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks [Time Frame: 6 weeks]

Secondary Outcome(s)

Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks [Time Frame: 6 weeks]

Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks [Time Frame: 6 weeks]

Secondary ID(s)

3055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Portland VA Medical Center

Results

• Results available: Yes
• Date Posted: 05/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01896700