NCT00307450

Brief Summary

The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

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, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

3 years

First QC Date

March 27, 2006

Last Update Submit

July 31, 2009

Conditions

Parkinson's Disease

Keywords

DyskinesiasParkinson's diseaseLevetiracetamTreatment

Outcome Measures

Primary Outcomes (2)

  • Modified AIMS

    11 weeks

  • UPDRS items 32 & 33

    11 weeks

Secondary Outcomes (8)

  • UPDRS

    11 weeks

  • Schwab & England scale

    11 weeks

  • Hoehn & Yahr scale

    11 weeks

  • GCI

    11 weeks

  • Patient day record

    11 weeks

  • +3 more secondary outcomes

Interventions

LevetiracetamDRUG

up to 200 mg per day in two dosages per day.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
  • Age of 30 to 80 years
  • Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
  • Written informed consent

You may not qualify if:

  • Atypical parkinsonian syndromes
  • Treatment with antipsychotics
  • Epilepsia or seizure in the history
  • Deep brain stimulation other than DBS in STN
  • Pregnant or lactating women
  • Severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology at the Technical University of Dresden

Dresden, 01307, Germany

Location

Department of Neurology at the University of Leipzig

Leipzig, 04103, Germany

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alexander Storch, M

    Technical University of Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

DE(2)