Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 439 for:    Methylphenidate

Methylphenidate to Improve Balance and Walking in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896700
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Methylphenidate
Drug: Placebo
Enrollment 24
Recruitment Details 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 .
Pre-assignment Details  
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Period Title: Overall Study
Started 12 12
Completed 8 6
Not Completed 4 6
Reason Not Completed
Adverse Event             4             5
Withdrawal by Subject             0             1
Arm/Group Title Methylphenidate Placebo Total
Hide Arm/Group Description

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
46.4  (7.9) 51.7  (8.7) 49.0  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
9
  75.0%
10
  83.3%
19
  79.2%
Male
3
  25.0%
2
  16.7%
5
  20.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
1
   8.3%
3
  12.5%
White
10
  83.3%
11
  91.7%
21
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12
 100.0%
12
 100.0%
24
 100.0%
1.Primary Outcome
Title Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 8 6
Mean (Standard Error)
Unit of Measure: change in seconds from basline
-0.7  (0.5) -1.3  (0.2)
2.Secondary Outcome
Title Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
Hide Description Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 6 4
Mean (Standard Error)
Unit of Measure: change in milliseconds from baseline
-9.2  (2.2) -5.3  (1.8)
3.Secondary Outcome
Title Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
Hide Description Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 8 6
Mean (Standard Error)
Unit of Measure: change in seconds from baseline
-0.3  (0.7) -0.6  (0.2)
4.Secondary Outcome
Title Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 8 6
Mean (Standard Error)
Unit of Measure: change in score from baseline
0.3  (0.9) -0.3  (0.7)
5.Secondary Outcome
Title Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 8 6
Mean (Standard Error)
Unit of Measure: change in score from baseline
-3.8  (3.5) -9.8  (4.4)
6.Secondary Outcome
Title Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: ratio
VOR Gain at 0.04 Hz -0.0107  (0.0868) -0.0229  (0.0521)
VOR Gain at 0.08 Hz -0.0061  (0.0759) -0.283  (0.0340)
VOR Gain at 0.16 Hz -0.0151  (0.0949) 0.0871  (0.0702)
VOR Gain at 0.32 Hz -0.0422  (0.1154) 0.0322  (0.0680)
VOR Gain at 0.64 Hz 0.0221  (0.0894) 0.0151  (0.0614)
7.Secondary Outcome
Title Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: change in % of asymmetry from baseline
VOR Asymmetry at 0.04 Hz 0.9927  (5.6664) -1.7291  (2.3367)
VOR Asymmetry at 0.08 Hz -0.0572  (5.6678) -6.5209  (1.9883)
VOR Asymmetry at 0.16 Hz 2.5833  (3.1565) -5.2852  (4.9239)
VOR Asymmetry at 0.32 Hz 1.9157  (5.1153) -4.1203  (5.4695)
VOR Asymmetry at 0.64 Hz 0.3104  (4.0893) -1.5111  (3.7015)
8.Secondary Outcome
Title Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: change in degrees from baseline
VOR Phase at 0.04 Hz 2.2790  (5.2622) 1.9535  (4.2274)
VOR Phase at 0.08 Hz 1.8914  (4.2548) -1.4716  (2.5754)
VOR Phase at 0.16 Hz 0.9449  (2.2400) -0.3342  (3.6845)
VOR Phase at 0.32 Hz -1.3564  (7.0617) 0.5981  (3.6808)
VOR Phase at 0.64 Hz -2.7082  (3.6010) 0.2833  (1.7800)
Time Frame Each participant was monitored for adverse events during the 6 weeks of their participation in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description

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

Placebo pill, bid for 6 weeks

Placebo: Escalating matched dose of placebo

All-Cause Mortality
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/12 (100.00%)   11/12 (91.67%) 
Cardiac disorders     
Elevated heart rate   1/12 (8.33%)  0/12 (0.00%) 
Gastrointestinal disorders     
Stomach ache/indigestion   1/12 (8.33%)  1/12 (8.33%) 
Constipation   3/12 (25.00%)  2/12 (16.67%) 
Nausea   1/12 (8.33%)  1/12 (8.33%) 
General disorders     
Chest pain/tightness   1/12 (8.33%)  0/12 (0.00%) 
Headache   2/12 (16.67%)  2/12 (16.67%) 
Insomnia   6/12 (50.00%)  4/12 (33.33%) 
Nightmares   1/12 (8.33%)  0/12 (0.00%) 
Fatigue   2/12 (16.67%)  0/12 (0.00%) 
Abdominal cramping   0/12 (0.00%)  1/12 (8.33%) 
Agitation   2/12 (16.67%)  0/12 (0.00%) 
Irritation   1/12 (8.33%)  0/12 (0.00%) 
Emotional detachment   1/12 (8.33%)  0/12 (0.00%) 
Tingling sensation   1/12 (8.33%)  0/12 (0.00%) 
Increased body heat   1/12 (8.33%)  1/12 (8.33%) 
Dry mouth   2/12 (16.67%)  0/12 (0.00%) 
Dizziness   1/12 (8.33%)  2/12 (16.67%) 
Reduced balance   1/12 (8.33%)  0/12 (0.00%) 
Infections and infestations     
Throat/ear infection   1/12 (8.33%)  0/12 (0.00%) 
Injury, poisoning and procedural complications     
Fall   0/12 (0.00%)  3/12 (25.00%) 
Car accident   1/12 (8.33%)  0/12 (0.00%) 
Metabolism and nutrition disorders     
Reduced appetite   1/12 (8.33%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Spasms of limbs   1/12 (8.33%)  0/12 (0.00%) 
Back pain   3/12 (25.00%)  0/12 (0.00%) 
Muscle weakness   2/12 (16.67%)  0/12 (0.00%) 
Muscle pain   3/12 (25.00%)  0/12 (0.00%) 
Nervous system disorders     
MS relapse   1/12 (8.33%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Coughing/sneezing/respiratory effects   1/12 (8.33%)  4/12 (33.33%) 
Shortness of breath   1/12 (8.33%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders     
Itchiness   3/12 (25.00%)  0/12 (0.00%) 
Rash   2/12 (16.67%)  0/12 (0.00%) 
Social circumstances     
Family emergency   0/12 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Elevated blood pressure   1/12 (8.33%)  3/12 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrea Hildebrand
Organization: Portland VA Health Care System
Phone: 503-220-8262 ext 52016
EMail: hildeand@ohsu.edu
Layout table for additonal information
Responsible Party: Michelle Cameron, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01896700     History of Changes
Other Study ID Numbers: 3055
First Submitted: July 8, 2013
First Posted: July 11, 2013
Results First Submitted: October 10, 2017
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018