Parkinson's DiseasePhase 4NCT01244269

The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.

A Phase 4 study testing Methylphenidate in people with Parkinson's Disease, run by Laval University at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages Up to 75 years
Conditions the study is for: Parkinson's Disease
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: 6 participants
Where: 2 sitesCanada
Study dates: Dec 2010to Jun 2011
Phase: Phase 4
Are there results?: None posted in the registry

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 Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with stages 2-3 Parkinson's disease as defined by the Hoehn \&Yahr staging system (Hoehn \&Yahr, 1967).
Age less than or equal to 75 years.
Subjects who are willing and able to provide, in writing, informed consent.
Subjects who are willing and able to be confined to the clinical research unit as required by the protocol and to complete all procedures required on an outpatient basis.

Who cannot join

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies and excluding seasonal allergies).
Subjects with a history of substance abuse or dependence or a positive urine screen for drugs of abuse.
A history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Subjects with a documented allergy to methylphenidate or one of the product excipients.
Subjects with any medical condition affecting drug absorption (e.g. gastrectomy).
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Use of a monoamine oxidase inhibitor or other interacting medication within the preceding 14 days or 5 half-lives (whichever is longer).
History of sensitivity to heparin or heparin-induced thrombocytopenia.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Québec Memory and Motor Skills Disorders Research Center
Québec, Quebec, G1S 2M2
Laval University
Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

Official title: Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.

This project aims to determine if methylphenidate can improve deficits in attention and symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on postural control in these patients, a debilitating motor symptom that places patients at an increased risk of falling. This study will build on existing data to support a new indication for the use of methylphenidate in Parkinson's Disease. Using standard and objective evaluations, this study will quantify the effect of methylphenidate at two doses on attention levels, orthostatic hypotension, and measures of postural control. Phase I of the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times daily to placebo. By incorporating two different doses, the study also seeks to determine if any improvements are dose-related. Secondary endpoints will include safety assessments (adverse event monitoring and vital signs) performed every 30 minutes following supervised drug administration. Visual analog scales will be presented to each participant before treatment and following the final dose of each treatment to assess changes in fatigue. A secondary task will be added to postural tests to assess the influence of cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial effect on all outcomes. It is projected that objective improvements will be observed following treatment with methylphenidate at both doses (10 and 20mg three time daily) when compared to placebo. It is further hypothesized that the effects will be dose-related and therefore more profound with higher doses.

Conditions: Parkinson's Disease
Being tested: Methylphenidate, Placebo 10, Placebo 20
Keywords: Parkinson's disease, Methylphenidate, Non motor symptoms, Postural control
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MethylphenidateDrug
Also called Ritalin
Methylphenidate 10mg tablets will be overencapsulated in gelatin capsules for blinding. Subjects will take 1 capsule three times daily for a total of 7 doses.
MethylphenidateDrug
Also called Ritalin
Methylphenidate 20mg three times daily for a total of 7 doses.
Placebo 10Drug
Blind gelatin capsule three times daily for a total of 7 doses.
Placebo 20Drug
Blind gelatin capsule three times daily for a total of 7 doses

Study groups in NCT01244269
Study group	Role	What they receive
Methylphenidate 10	Experimental	Methylphenidate 10mg three times daily for a total of 7 doses. Receives: Drug: Methylphenidate
Placebo 10	Placebo comparator	Placebo capsule three times daily for a total of 7 doses. Receives: Drug: Placebo 10
Methylpheindate 20	Experimental	Methylphenidate 20mg three times daily for a total of 7 doses. Receives: Drug: Methylphenidate
Placebo 20	Placebo comparator	Placebo capsule three times daily for a total of 7 doses. Receives: Drug: Placebo 20

What is being measured

The primary outcome is the main question the study is designed to answer.

Conners' Continuous Performance Test-II score
Measured: Baseline, 2 hours following first dose, 2 hours following last dose
Orthostatic drop - blood pressure in mmHg
Blood pressure will be measured following 5 minutes of rest in a lying position and again 1, 3, and 5 minutes after rising to a standing position. The orthostatic drop will be calculated by subtracting the blood pressures recorded at each time interval(1, 3, and 5 minutes after standing) from the blood pressure recorded in a lying position.
Measured: Baseline, 2 hours following first dose, 2 hours following last dose
Average speed of center of pressure oscillations
As recorded using dynamic posturography (Sensory Organization Test).
Measured: Baseline, 2 hours following first dose, 2 hours following last dose
Total area of center of pressure oscillations
As recorded using dynamic posturography (Sensory Organization Test).
Measured: Baseline, 2 hours following first dose, 2 hours following last dose

Secondary outcomes (4)

Visual analog fatigue scale scores
Measured: Baseline, 2 hours following last dose
Blood pressure (mmHg)
Measured: Baseline, 30, 60, and 90 minutes following first and final dose of study medication
Heart rate
Measured: Basesline, 30, 60, and 90 minutes following first and final dose of study medication
Number of errors recorded for 'Backward Digit Span' task
Following administration of the Backward Digit Span assessment of the Wechsler Adult Intelligence Scale to control for individual capacities, each subject will be provided with a string of digits before the onset of 50% of the trials in the postural test. Subjects will be required to memorize the string of digits in reverse and repeat them at the end of the trial. Errors will be quantified as either errors of insertion, deletion, or order.
Measured: Baseline, 2 hours following first dose, 2 hours following final dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jun 2011

First posted19 Nov 2010 (estimated)
Study startDec 2010
Primary completionJun 2011
Study completionJun 2011

Why it stopped: Inadequate enrolment, protocol too challenging for participants, lack of observable benefit after analysis of 6 patients.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Laval UniversityThe 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01244269
Sponsor's protocol ID: MPH.NMS.2011
Status last verified: Oct 2012
First submitted: 18 Nov 2010
Last updated: 22 Oct 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.
ClinicalTrials.gov ID: NCT01244269
Acronym / sponsor ID: MPH.NMS.2011
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, Methylphenidate, Non motor symptoms, Postural control
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inadequate enrolment, protocol too challenging for participants, lack of observable benefit after analysis of 6 patients.
Enrolment: 6 participants (actual)
Lead sponsor: Laval UniversityUniversity, hospital or other
Collaborators: Fonds de la Recherche en Santé du Québec, Quebec Memory and Motor Skills Disorders Research Center
Study start: Dec 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Methylphenidate 10	Experimental	Drug: MethylphenidateMethylphenidate 10mg three times daily for a total of 7 doses.
Placebo 10	Placebo comparator	Drug: Placebo 10Placebo capsule three times daily for a total of 7 doses.
Methylpheindate 20	Experimental	Drug: MethylphenidateMethylphenidate 20mg three times daily for a total of 7 doses.
Placebo 20	Placebo comparator	Drug: Placebo 20Placebo capsule three times daily for a total of 7 doses.

Who may qualify

Ages: Up to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Patients with stages 2-3 Parkinson's disease as defined by the Hoehn \&Yahr staging system (Hoehn \&Yahr, 1967).
Age less than or equal to 75 years.
Subjects who are willing and able to provide, in writing, informed consent.
Subjects who are willing and able to be confined to the clinical research unit as required by the protocol and to complete all procedures required on an outpatient basis.

Key exclusion criteria (8 listed)

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies and excluding seasonal allergies).
Subjects with a history of substance abuse or dependence or a positive urine screen for drugs of abuse.
A history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Subjects with a documented allergy to methylphenidate or one of the product excipients.
Subjects with any medical condition affecting drug absorption (e.g. gastrectomy).

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: RitalinMethylphenidate 10mg tablets will be overencapsulated in gelatin capsules for blinding. Subjects will take 1 capsule three times daily for a total of 7 doses.	Drug	Methylphenidate 10
MethylphenidateAlso: RitalinMethylphenidate 20mg three times daily for a total of 7 doses.	Drug	Methylpheindate 20
Placebo 10Blind gelatin capsule three times daily for a total of 7 doses.	Drug	Placebo 10
Placebo 20Blind gelatin capsule three times daily for a total of 7 doses	Drug	Placebo 20

Primary outcome

Conners' Continuous Performance Test-II score
Time frame: Baseline, 2 hours following first dose, 2 hours following last dose
Orthostatic drop - blood pressure in mmHg
Time frame: Baseline, 2 hours following first dose, 2 hours following last dose
Blood pressure will be measured following 5 minutes of rest in a lying position and again 1, 3, and 5 minutes after rising to a standing position. The orthostatic drop will be calculated by subtracting the blood pressures recorded at each time interval(1, 3, and 5 minutes after standing) from the blood pressure recorded in a lying position.
Average speed of center of pressure oscillations
Time frame: Baseline, 2 hours following first dose, 2 hours following last dose
As recorded using dynamic posturography (Sensory Organization Test).
Total area of center of pressure oscillations
Time frame: Baseline, 2 hours following first dose, 2 hours following last dose
As recorded using dynamic posturography (Sensory Organization Test).

4 secondary outcomes

Visual analog fatigue scale scores
Time frame: Baseline, 2 hours following last dose
Blood pressure (mmHg)
Time frame: Baseline, 30, 60, and 90 minutes following first and final dose of study medication
Heart rate
Time frame: Basesline, 30, 60, and 90 minutes following first and final dose of study medication
Number of errors recorded for 'Backward Digit Span' task
Time frame: Baseline, 2 hours following first dose, 2 hours following final dose

Results and safety

The study was stopped early (reason given: Inadequate enrolment, protocol too challenging for participants, lack of observable benefit after analysis of 6 patients.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
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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.

Philippe Corbeil, PhD study director

Laval University

Jaime McDonald, BScPhm study director

Laval University

Emmanuelle Pourcher, MD principal investigator

Québec Memory and Motor Skills Disorders Research Center

2 sites 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 in people with Parkinson's Disease, run by Laval University at 2 sites in Canada.

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 8 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: stopped early, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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?

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?

Conners' Continuous Performance Test-II score (time frame: Baseline, 2 hours following first dose, 2 hours following last dose). The study lists 4 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 NCT01244269.

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 Oct 2012.