Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: modafinil (Drug); methylphenidate (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Gabriel Bucurescu, MD MS, Principal Investigator, Affiliation: Philadelphia, OPC
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.
Clinical Details
Official title: Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks
Secondary outcome: Compare the safety profile of modafinil and methylphenidate
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.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Philadelphia, OPC, Philadelphia, Pennsylvania 19106, United States
Additional Information
Starting date: March 2006
Ending date: October 2007
Last updated: March 11, 2008
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