Parkinson's DiseasePhase 4NCT00526630
Methylphenidate for the Treatment of Gait Impairment in Parkinson's Disease
A Phase 4 study testing Methylphenidate (MPD) in people with Parkinson's Disease and Gait Impairment, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson's Disease, Gait Impairment
- What is being tested?
- Methylphenidate (MPD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2009
- Phase
- Phase 4
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a definite diagnosis of Parkinson's disease for at least 5 years.
- Patients with mild to severe gait disturbance.
- Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments.
- Mini-Mental State Examination (MMSE) score of 25 or greater.
Who cannot join
- Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait.
- Previous treatment with DBS (deep brain stimulation).
- Those with history of stroke.
- Those with cerebellar, vestibular, or sensory ataxia.
- Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline).
- Women of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Neurology-Movement Disorders Clinic
Cincinnati, Ohio, 45219
About this study
Official title: Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study
The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD.
The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.
Read the detailed description
There are a total of six clinic visits involved in this study. All study-related assessments will take place first during the practically defined off period, that is, in the morning after at least 12 hours from the last dose of any antiparkinsonian medication, followed by a repeat assessment once the "on" state is clearly identified by the patient and examiner (approximately 30 to 60 minutes after taking your Parkinson's medication). This "practically defined off period" state is considered the desired state on which to report motor changes for any currently available or experimental intervention in PD. Patients will be off his or her Parkinson's medication for no more than 14 hours for each of the assessments. Studying patients in the off-period is the most widely used manner in which the value of new therapies can be fully measured.
During the first visit, patients will be "randomized" into one of the study groups described below. Neither the participant nor the researcher conducting this study will choose what group he or she will be in.
Participants will receive either placebo or a dose of 1 mg/kg of Methylphenidate capsules divided into three doses (at 8 am, 12 noon, and 4 pm). An increase in medication over a four week period will be used until a target dosage is reached, which may range from 5 to 8 10-mg capsules per day.
A measure of balance will be taken during both patient's "off" and "on" motor states during each of the study visits. Patients will be asked to stand on a force plate (a piece of equipment that measures your balance and is located in the floor) for thirty seconds in a total of four conditions. The four sessions will be carried out as follows: (1) with eyes open while standing on firm surface, (2) with eyes closed while standing on firm surface, (3) with eyes open while standing on foam surface, and (4) with eyes closed while standing on foam surface. These sessions will be in random order and will be repeated up to 4 times.
During all the study visits, the physician will ask patients to perform some physical tests during which the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr (H\&Y) will be used to assess the severity of the patient's Parkinson's disease. Each assessment will take place during both patient's "off" and "on" motor states. Instruments that will also be used are the self-administered Freezing of Gait Questionnaire (FOGQ), to evaluate walking difficulties, and the Gait-Falls diary, to document all indoor and outdoor freezing, tripping, and falls. To assess changes in mood, patients will also complete the following instruments: the Montgomery-Asberg Depression scale (MADRS), the 15-item Geriatric Depression Scale (GDS-15) and the 20-item Zung Self-Rating Depression scale (Zung). To assess quality of life and activities of daily living, patients will complete the EQ-5D Health Questionnaire. Finally, patients will be asked to complete the Epworth Sleepiness Scale (ESS) to document any changes in sleep patterns.
After the first visit, patients will begin a four week increase in medication in order to reach a target dose. At the fourth visit, patients will receive the opposite treatment of what was received the first time and another four-week increase in medication will take place. If Methylphenidate was given at the first visit, patients will receive placebo on the third visit and vice versa. There will be a three week period where patients will not take the study medication (either Methylphenidate or placebo), between the third and fourth visit. At all study visits, during both patient's "off" and "on" motor states, patients will have balance testing. The physician will evaluate the severity of patient's disease using the UPDRS and the H\&Y. Patients will be asked to complete the FOGQ and the Gait-Falls diary.
- Conditions
- Parkinson's Disease, Gait Impairment
- Being tested
- Methylphenidate (MPD), Placebo
- Keywords
- freezing, gait, festination, shuffling, balance
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate (MPD)Drug
Also called Ritalin
Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day.
PlaceboDrug
Participants will be given placebo instead of active MPD.
| Study group | Role | What they receive |
|---|---|---|
| 1. MPD | Active comparator | Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo. Receives: Drug: Methylphenidate (MPD) |
| 2. Placebo | Placebo comparator | Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.
Gait stride length is the distance between two consecutive steps in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
Measured: Week 12 and 27
The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.
Gait velocity is a measure of distance over time in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
Measured: Week 12 and 27
Secondary outcomes (6)
The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks
Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson's disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn \& Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment.
Measured: At week 12 and 27
Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.
Freezing and shuffling are measures of ambulatory impairment.
Measured: Week 12 and 27
Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.
FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment).
Measured: Week 12 and 27
Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.
MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
Measured: Week 12 and 27
The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness.
Measured: Week 12 and 27
The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status.
Measured: Week 12 and 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Alberto Espay, University of Cincinnati
- Investigators
- Alberto Espay, MD, Principal investigator, University of Cincinnati-Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526630
- Sponsor's protocol ID
- 07-06-19-07
- Status last verified
- Apr 2015
- First submitted
- 5 Sep 2007
- Last updated
- 22 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Espay AJ, Dwivedi AK, Payne M, Gaines L, Vaughan JE, Maddux BN, Slevin JT, Gartner M, Sahay A, Revilla FJ, Duker AP, Shukla R. Methylphenidate for gait impairment in Parkinson disease: a randomized clinical trial. Neurology. 2011 Apr 5;76(14):1256-62. doi: 10.1212/WNL.0b013e3182143537.
PubMed 21464430
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT00526630
- Acronym / sponsor ID
- 07-06-19-07
- Conditions
- Parkinson's Disease, Gait Impairment
- Keywords
- freezing, gait, festination, shuffling, balance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 22 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD.
The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.
Detailed description
There are a total of six clinic visits involved in this study. All study-related assessments will take place first during the practically defined off period, that is, in the morning after at least 12 hours from the last dose of any antiparkinsonian medication, followed by a repeat assessment once the "on" state is clearly identified by the patient and examiner (approximately 30 to 60 minutes after taking your Parkinson's medication). This "practically defined off period" state is considered the desired state on which to report motor changes for any currently available or experimental intervention in PD. Patients will be off his or her Parkinson's medication for no more than 14 hours for each of the assessments. Studying patients in the off-period is the most widely used manner in which the value of new therapies can be fully measured.
During the first visit, patients will be "randomized" into one of the study groups described below. Neither the participant nor the researcher conducting this study will choose what group he or she will be in.
Participants will receive either placebo or a dose of 1 mg/kg of Methylphenidate capsules divided into three doses (at 8 am, 12 noon, and 4 pm). An increase in medication over a four week period will be used until a target dosage is reached, which may range from 5 to 8 10-mg capsules per day.
A measure of balance will be taken during both patient's "off" and "on" motor states during each of the study visits. Patients will be asked to stand on a force plate (a piece of equipment that measures your balance and is located in the floor) for thirty seconds in a total of four conditions. The four sessions will be carried out as follows: (1) with eyes open while standing on firm surface, (2) with eyes closed while standing on firm surface, (3) with eyes open while standing on foam surface, and (4) with eyes closed while standing on foam surface. These sessions will be in random order and will be repeated up to 4 times.
During all the study visits, the physician will ask patients to perform some physical tests during which the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr (H\&Y) will be used to assess the severity of the patient's Parkinson's disease. Each assessment will take place during both patient's "off" and "on" motor states. Instruments that will also be used are the self-administered Freezing of Gait Questionnaire (FOGQ), to evaluate walking difficulties, and the Gait-Falls diary, to document all indoor and outdoor freezing, tripping, and falls. To assess changes in mood, patients will also complete the following instruments: the Montgomery-Asberg Depression scale (MADRS), the 15-item Geriatric Depression Scale (GDS-15) and the 20-item Zung Self-Rating Depression scale (Zung). To assess quality of life and activities of daily living, patients will complete the EQ-5D Health Questionnaire. Finally, patients will be asked to complete the Epworth Sleepiness Scale (ESS) to document any changes in sleep patterns.
After the first visit, patients will begin a four week increase in medication in order to reach a target dose. At the fourth visit, patients will receive the opposite treatment of what was received the first time and another four-week increase in medication will take place. If Methylphenidate was given at the first visit, patients will receive placebo on the third visit and vice versa. There will be a three week period where patients will not take the study medication (either Methylphenidate or placebo), between the third and fourth visit. At all study visits, during both patient's "off" and "on" motor states, patients will have balance testing. The physician will evaluate the severity of patient's disease using the UPDRS and the H\&Y. Patients will be asked to complete the FOGQ and the Gait-Falls diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. MPD | Active comparator | Drug: Methylphenidate (MPD)Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo. |
| 2. Placebo | Placebo comparator | Drug: PlaceboRandomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a definite diagnosis of Parkinson's disease for at least 5 years.
- Patients with mild to severe gait disturbance.
- Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments.
- Mini-Mental State Examination (MMSE) score of 25 or greater.
Key exclusion criteria (6 listed)
- Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait.
- Previous treatment with DBS (deep brain stimulation).
- Those with history of stroke.
- Those with cerebellar, vestibular, or sensory ataxia.
- Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline).
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 |
|---|---|---|
| Methylphenidate (MPD)Also: RitalinParticipants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day. | Drug | 1. MPD |
| PlaceboParticipants will be given placebo instead of active MPD. | Drug | 2. Placebo |
Primary outcome
The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
Gait stride length is the distance between two consecutive steps in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
Gait velocity is a measure of distance over time in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
6 secondary outcomes
The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks
Time frame: At week 12 and 27
Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks
Time frame: Week 12 and 27
The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.
Time frame: Week 12 and 27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21464430Espay AJ, Dwivedi AK, Payne M, Gaines L, Vaughan JE, Maddux BN, Slevin JT, Gartner M, Sahay A, Revilla FJ, Duker AP, Shukla R. Methylphenidate for gait impairment in Parkinson disease: a randomized clinical trial. Neurology. 2011 Apr 5;76(14):1256-62. doi: 10.1212/WNL.0b013e3182143537.
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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.
Alberto Espay, MD principal investigator
University of Cincinnati-Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate (MPD) in people with Parkinson's Disease and Gait Impairment, run by University of Cincinnati 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 4 inclusion and 6 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 22 Apr 2015. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 22 Apr 2015). 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?
The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks. (time frame: Week 12 and 27). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526630, which also lists 1 linked publication.
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 22 Apr 2015.