Multiple SclerosisPhase 2/3NCT01896700
Methylphenidate to Improve Balance and Walking in MS
A Phase 2/3 study testing Methylphenidate in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Methylphenidate, Placebo
- Keywords
- Multiple sclerosis, postural balance, walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
PlaceboDrug
Escalating matched dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | 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 Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | Placebo pill, bid for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.
Measured: 6 weeks
Secondary outcomes (7)
Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
Measured: 6 weeks
Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
Measured: 6 weeks
Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks
Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-21 points, with higher numbers indicating poorer sleep quality.
Measured: 6 weeks
Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks
Mean changes in the score attached on the Modified Fatigue Index Scale at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-84 points, with higher scores indicating greater fatigue.
Measured: 6 weeks
Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks
The most common rotary chair testing is a battery of subtests, each at a specific rate (Hz) of chair rotation from side to side. The participant is secured in the chair in total darkness while the eyes are monitored by infrared cameras. We completed tests from 0.04 to 0.64 Hz to assess the vestibular system across a range of head movements. The chair and participant's head move together while the cameras track the velocity of the eyes; eye velocity reveals how the vestibular system responds to head velocity. VOR gain is the ratio of average chair (i.e. head) velocity to average eye velocity, and is represented on a unitless scale from 0 to 1. VOR gain close to 1 indicates that eye velocity is nearly equal and opposite to head velocity. While there are normative ranges for VOR gain, we are most interested in is change in mean gain (6-week tests minus baseline tests) for the active and placebo groups.
Measured: 6 weeks
Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks
Mean changes in VOR asymmetry, which is a measure of the strength of the eye responses in one direction compared with the other as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.
Measured: 6 weeks
Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks
Mean changes in VOR phase, which is a measure of the timing (in degrees) of the eye movements relative to the chair movement, as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Principal investigator, Michelle Cameron, Oregon Health and Science University
- Investigators
- Michelle Cameron, PT, MD, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896700
- Sponsor's protocol ID
- 3055
- Status last verified
- Mar 2018
- First submitted
- 8 Jul 2013
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate to Improve Balance and Walking in MS
- ClinicalTrials.gov ID
- NCT01896700
- Acronym / sponsor ID
- 3055
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, postural balance, walking
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- Jul 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateIntervention: 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 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill, bid for 6 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: RitalinEscalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each | Drug | Methylphenidate |
| PlaceboEscalating matched dose of placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
Time frame: 6 weeks
The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.
7 secondary outcomes
Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
Time frame: 6 weeks
Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
Time frame: 6 weeks
Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score 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 Vestibular-Ocular Reflex (VOR) Gain 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) Phase (in Degrees) at 6 Weeks
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Cameron, PT, MD principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylphenidate in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.