Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease

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. Identifier: NCT00393562
Recruitment Status : Withdrawn (Unable to recruit any subjects for this study)
First Posted : October 30, 2006
Last Update Posted : June 26, 2015
Information provided by:
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: modafinil Drug: methylphenidate Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks

Secondary Outcome Measures :
  1. Compare the safety profile of modafinil and methylphenidate

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Veteran at study site

Exclusion Criteria:

  • Patients unable to give consent
  • Diagnosis of EDS prior to diagnosis of PD
  • Brain injury due to trauma, CVA, tumor or anoxia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393562

United States, Pennsylvania
Philadelphia, OPC
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
US Department of Veterans Affairs
Principal Investigator: Gabriel Bucurescu, MD MS Philadelphia, OPC

Responsible Party: Bucurescu, Gabriel - Principal Investigator, Department of Veterans Affairs Identifier: NCT00393562     History of Changes
Other Study ID Numbers: PADRECC 01
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
excessive sleepiness
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers