NCT00103805

Brief Summary

The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4 healthy

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

March 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

February 14, 2005

Last Update Submit

May 20, 2014

Conditions

Healthy

Keywords

language acquisitionplasticitystroke recoveryassociative learning

Outcome Measures

Primary Outcomes (1)

  • Boost in language learning success through levodopa compared to placebo

Secondary Outcomes (1)

  • Stability of language learning success after one month

Interventions

levodopaDRUG

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • years old
  • Right handedness

You may not qualify if:

  • Neurological/psychiatric/metabolic/cardiac disorders
  • Asthma
  • Known allergic reactions to one of the experimental drugs
  • Other drugs affecting the central nervous system
  • Leisure drug ingestion during the past 4 weeks (urine test)
  • Smoking cessation during the past 2 weeks
  • \> 6 cups of coffee or energy drinks per day
  • \> 10 cigarettes per day
  • \> 50 grams of alcohol per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (2)

  • Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.

    PMID: 15236398BACKGROUND

  • Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.

    PMID: 15114342BACKGROUND

MeSH Terms

Interventions

Levodopa

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Caterina Breitenstein, PhD

    Dept. of Neurology, University of Muenster, Germany

    STUDY DIRECTOR

  • Stefan Knecht, MD

    Dept. of Neurology, University of Muenster, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2005

First Posted

February 15, 2005

Study Start

March 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

DE(1)