Parkinson's DiseaseNCT00393562
Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
A study testing modafinil and methylphenidate in people with Parkinson's Disease, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is an open-label cross-over randomized control study comparing the effect of modafinil and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- modafinil and methylphenidate
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2007
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran at study site
Who cannot join
- Patients unable to give consent
- Diagnosis of EDS prior to diagnosis of PD
- Brain injury due to trauma, CVA, tumor or anoxia
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label cross-over randomized control study comparing the effect of modafinil and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness.
Read the detailed description
Sleep disorders are common in Parkinson's disease (PD) and a significant cause of impairment of function in already disabled individuals. Almost all patients with PD report disturbed sleep, including excessive daytime sleepiness (EDS), disorders of initiating and maintaining sleep (DIMS) or parasomnias.1 The underlying pathology associated with PD and medication effects have both been implicated in the sleep disorders affecting these patients. EDS has become the focus of attention because of its effect on quality of life and impairment in driving and predisposition to traffic accidents. Its prevalence has been estimated between 15-50%. Treatment of EDS has become an important factor in the management of the PD patient, and the recent introduction of modafinil, a wakefulness promoting agent approved for narcolepsy, has led to increasing off-label use of this agent. Prior to modafinil, amphetamine and methylphenidate, two classical psychostimulants, were the agents of choice in treating EDS. However, these agents also have a direct effect on the dopaminergic system. They increase both sleep and REM latency, while reducing total sleep time and REM sleep. By comparison, the mechanism of action of modafinil is unknown, yet distinct from that of the psychostimulants. A direct comparison of the effect on EDS of modafinil with classical psychostimulants is lacking. The overall goals of this research proposal are to determine which agent is most effective in treating EDS in PD patients by using an open-label randomized control study comparing efficacy, onset of action and tolerability.
- Conditions
- Parkinson's Disease
- Being tested
- modafinil, methylphenidate
- Keywords
- excessive sleepiness, hypersomnolence, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
methylphenidateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks
Secondary outcomes (1)
Compare the safety profile of modafinil and methylphenidate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Unable to recruit any subjects for this study
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Gabriel Bucurescu, MD MS, Principal investigator, Philadelphia, OPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393562
- Sponsor's protocol ID
- PADRECC 01
- Status last verified
- Jun 2015
- First submitted
- 26 Oct 2006
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00393562
- Acronym / sponsor ID
- PADRECC 01
- Conditions
- Parkinson's Disease
- Keywords
- excessive sleepiness, hypersomnolence, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit any subjects for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Oct 2006 (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.
This is an open-label cross-over randomized control study comparing the effect of modafinil and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness.
Detailed description
Sleep disorders are common in Parkinson's disease (PD) and a significant cause of impairment of function in already disabled individuals. Almost all patients with PD report disturbed sleep, including excessive daytime sleepiness (EDS), disorders of initiating and maintaining sleep (DIMS) or parasomnias.1 The underlying pathology associated with PD and medication effects have both been implicated in the sleep disorders affecting these patients. EDS has become the focus of attention because of its effect on quality of life and impairment in driving and predisposition to traffic accidents. Its prevalence has been estimated between 15-50%. Treatment of EDS has become an important factor in the management of the PD patient, and the recent introduction of modafinil, a wakefulness promoting agent approved for narcolepsy, has led to increasing off-label use of this agent. Prior to modafinil, amphetamine and methylphenidate, two classical psychostimulants, were the agents of choice in treating EDS. However, these agents also have a direct effect on the dopaminergic system. They increase both sleep and REM latency, while reducing total sleep time and REM sleep. By comparison, the mechanism of action of modafinil is unknown, yet distinct from that of the psychostimulants. A direct comparison of the effect on EDS of modafinil with classical psychostimulants is lacking. The overall goals of this research proposal are to determine which agent is most effective in treating EDS in PD patients by using an open-label randomized control study comparing efficacy, onset of action and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veteran at study site
Key exclusion criteria (3 listed)
- Patients unable to give consent
- Diagnosis of EDS prior to diagnosis of PD
- Brain injury due to trauma, CVA, tumor or anoxia
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 |
|---|---|---|
| modafinil | Drug | – |
| methylphenidate | Drug | – |
Primary outcome
Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks
1 secondary outcome
Compare the safety profile of modafinil and methylphenidate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Gabriel Bucurescu, MD MS principal investigator
Philadelphia, OPC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modafinil and methylphenidate in people with Parkinson's Disease, run by US Department of Veterans Affairs 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 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 26 Jun 2015.