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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00393562
• Other study ID #: PADRECC 01
• Status: Withdrawn
• Phase: N/A
• First received: October 26, 2006
• Last updated: June 25, 2015
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• modafinil

• methylphenidate

Locations

Country	Name	City	State
United States	Philadelphia, OPC	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks			No
Secondary	Compare the safety profile of modafinil and methylphenidate			No