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

This study has been terminated.
(Unable to recruit any subjects for this study)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00393562
First received: October 26, 2006
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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 Intervention
Parkinson's Disease
Drug: modafinil
Drug: methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Compare efficacy of the two agents in treating excessive daytime sleepiness at 4 and 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the safety profile of modafinil and methylphenidate [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393562

Locations
United States, Pennsylvania
Philadelphia, OPC
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Investigators
Principal Investigator: Gabriel Bucurescu, MD MS Philadelphia, OPC
  More Information

No publications provided

Responsible Party: Bucurescu, Gabriel - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00393562     History of Changes
Other Study ID Numbers: PADRECC 01
Study First Received: October 26, 2006
Last Updated: March 11, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
excessive sleepiness
hypersomnolence
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
Methylphenidate
Modafinil
Armodafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on September 18, 2014