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| Name | Class |
|---|---|
| Portland VA Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo pill, bid for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Cameron, PT, MD | Portland VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
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24 people with MS and imbalance from the MS clinics in the Portland, OR metropolitan area were enrolled into this study between September 2013 and March 2016 .
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate | 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 Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each |
| FG001 | Placebo | Placebo pill, bid for 6 weeks Placebo: Escalating matched dose of placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate | 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 Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | change in seconds from basline | 6 weeks |
|
Each participant was monitored for adverse events during the 6 weeks of their participation in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylphenidate | 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 Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated blood pressure | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Hildebrand | Portland VA Health Care System | 503-220-8262 | 52016 | hildeand@ohsu.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Escalating matched dose of placebo |
|
Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. |
| 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. | 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. | 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. | 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. | 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. | 6 weeks |
| Placebo |
Placebo pill, bid for 6 weeks Placebo: Escalating matched dose of placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Placebo pill, bid for 6 weeks
Placebo: Escalating matched dose of placebo
|
|
| Secondary | 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. | Population discrepancy: One participant in the intervention group and two participants in the placebo group contributed unusable APR data; due to their balance deficits, the machine could not get an accurate reading for this test. One participant in the intervention group declined this test. These four participants were not included in analysis. | Posted | Mean | Standard Error | change in milliseconds from baseline | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | change in seconds from baseline | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | change in score from baseline | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | change in score from baseline | 6 weeks |
|
|
|
| Secondary | 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. | Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed. | Posted | Mean | Standard Deviation | ratio | 6 weeks |
|
|
|
| Secondary | 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. | Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed. | Posted | Mean | Standard Deviation | change in % of asymmetry from baseline | 6 weeks |
|
|
|
| Secondary | 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. | Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed. | Posted | Mean | Standard Deviation | change in degrees from baseline | 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Placebo | Placebo pill, bid for 6 weeks Placebo: Escalating matched dose of placebo | 0 | 12 | 0 | 12 | 11 | 12 |
| Elevated heart rate | Cardiac disorders | Systematic Assessment |
|
| Chest pain/tightness | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Nightmares | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Stomach ache/indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal cramping | General disorders | Systematic Assessment |
|
| Reduced appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Agitation | General disorders | Systematic Assessment |
|
| Irritation | General disorders | Systematic Assessment |
|
| Emotional detachment | General disorders | Systematic Assessment |
|
| Spasms of limbs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tingling sensation | General disorders | Systematic Assessment |
|
| Increased body heat | General disorders | Systematic Assessment |
|
| Coughing/sneezing/respiratory effects | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat/ear infection | Infections and infestations | Systematic Assessment |
|
| Reduced balance | General disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| MS relapse | Nervous system disorders | Systematic Assessment |
|
| Family emergency | Social circumstances | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| VOR Gain at 0.16 Hz |
|
| VOR Gain at 0.32 Hz |
|
| VOR Gain at 0.64 Hz |
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| VOR Asymmetry at 0.16 Hz |
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| VOR Asymmetry at 0.32 Hz |
|
| VOR Asymmetry at 0.64 Hz |
|
| VOR Phase at 0.16 Hz |
|
| VOR Phase at 0.32 Hz |
|
| VOR Phase at 0.64 Hz |
|