NCT00408915

Brief Summary

The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced Parkinson's disease with motor fluctuations and "OFF" periods refractory to conventional treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

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, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

First QC Date

December 5, 2006

Last Update Submit

March 6, 2012

Conditions

Parkinson's Disease

Keywords

LisurideContinuous Dopaminergic StimulationMotor FluctuationsOff-TimesTroublesome DyskinesiaParkinson's Disease with motor fluctuations with OFF periods and/or troublesome dyskinesias of more than four hours per day

Outcome Measures

Primary Outcomes (1)

  • Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia

Secondary Outcomes (3)

  • Secondary objectives are to evaluate quality of life, quality of sleep, UPDRS Score

  • clinical global impression, safety and tolerability.

  • After the double-blind period, long-term efficacy of lisuride will be assessed for further 2 years in an open-label extension of the study

Interventions

Continuous Subcutaneous Lisuride InfusionDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease for at least 3 years (diagnosis based on the UK Brain Bank Criteria)
  • Presence of motor fluctuations (wearing-off or other "OFF" periods) and / or presence of troublesome dyskinesia, with a total daily minimum of at least 4 hours, despite optimized oral anti-parkinsonian therapy
  • Stable levodopa intake, i.e. at least four doses of levodopa per day
  • The following oral dopamine agonist drugs are allowed in this trial: pramipexol up to a total daily dose of 3,15mg, ropinirol up to a total daily dose of 24mg, cabergoline up to a total daily dose of 6mg or combinations Concomitant diseases are stable and well controlled Willingness and ability to comply with all trial requirements Written informed consent

You may not qualify if:

  • Non-idiopathic Parkinson's disease (e.g. drug-induced or other forms of secondary or atypical parkinsonism such as MSA)
  • Significant neurological symptoms not accounted for by Parkinson's disease
  • History or presence of dementia demonstrated by the Mini-mental status examination (MMSE \< 24)
  • Presence of major depression according to DSM IV criteria (≥ 6 months)
  • History or presence of epilepsy
  • Presence of dopaminergic psychosis
  • Unstable severe concomitant diseases (e.g. liver diseases, kidney diseases or clinically relevant cardiac or coronary dysfunction)
  • Presence of heart valvular fibrosis or indication of significant valvular stenosis / insufficiency on echocardiogram
  • History of syncope and/or severe or otherwise symptomatic orthostatic hypotension
  • Present treatment with neuroleptics, including atypical neuroleptics
  • Treatment with other CNS active drug therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics) unless the dose has been stable for at least four weeks prior to the baseline visit
  • Participation in another trial of an investigational drug within the last 28 days or current participation in another trial of an investigational drug
  • Clinically significant laboratory abnormalities
  • Previous neurosurgery for Parkinson's disease
  • Alcohol or drug abuse in the past three years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imerem GmbH

Nuremberg, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • J. Winkler, Professor

    Klinik und Poliklinik für Neurologie der Universität Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 7, 2006

Study Start

July 1, 2006

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

DE(1)