NCT00359723

Brief Summary

The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

July 31, 2006

Last Update Submit

November 27, 2018

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasePDmethylphenidateRitalinMPD

Outcome Measures

Primary Outcomes (1)

  • Time "on" defined by tapping speed

Study Arms (2)

Methylphenidate 0.4 mg/kg TID followed by placebo TID

EXPERIMENTAL

As above

Drug: methylphenidate

Placebo TID followed by methylphenidate 0.4 mg/kg TID

EXPERIMENTAL

As above

Drug: methylphenidate

Interventions

methylphenidateDRUG
Methylphenidate 0.4 mg/kg TID followed by placebo TIDPlacebo TID followed by methylphenidate 0.4 mg/kg TID

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic PD treated with levodopa and experiencing motor fluctuations
  • At least 21 years of age
  • Male or female.

You may not qualify if:

  • Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Nutt JG, Carter JH, Carlson NE. Effects of methylphenidate on response to oral levodopa: a double-blind clinical trial. Arch Neurol. 2007 Mar;64(3):319-23. doi: 10.1001/archneur.64.3.319.

    PMID: 17353373RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John G. Nutt, MD

    Professor of Neurology, Oregon Health Science University

    PRINCIPAL INVESTIGATOR

  • Julie H. Carter, ANP

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Nichole T. Carlson, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 2, 2006

Study Start

July 1, 2004

Primary Completion

January 1, 2006

Study Completion

March 1, 2006

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

US(1)