NCT00393562

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

October 26, 2006

Last Update Submit

June 25, 2015

Conditions

Parkinson's Disease

Keywords

excessive sleepinesshypersomnolenceParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

modafinilDRUG
methylphenidateDRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran at study site

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia, OPC

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDisorders of Excessive Somnolence

Interventions

ModafinilMethylphenidate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gabriel Bucurescu, MD MS

    Philadelphia, OPC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(1)