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A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

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ClinicalTrials.gov Identifier: NCT00903838
Recruitment Status : Terminated (The study was terminated on 31 May, 2011, due to strategic considerations.)
First Posted : May 18, 2009
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.

Condition or disease Intervention/treatment Phase
Advanced Stage Parkinson's Disease Drug: pardoprunox Drug: pramipexole Phase 2

Detailed Description:
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
Study Start Date : September 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: pardoprunox
1.5 to 12 mg/day
Active Comparator: 2 Drug: pramipexole
0.75-4.5 mg/day

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to endpoint in ON-time without dyskinesia [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4 [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Patients who have signed informed consent
  • Diagnosis of idiopathic Parkinson's Disease
  • Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
  • Presence of a recognizable ON and OFF state (motor fluctuations)
  • Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
  • Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries
  • Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 >= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 >=2)

Exclusion Criteria

  • Diagnosis is unclear or a suspicion of other parkinsonian syndromes
  • Patients who have undergone surgery for the treatment of PD
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903838

Site Reference ID/Investigator# 45433
Goettingen, Germany, 37075
Site Reference ID/Investigator# 45428
Kassel, Germany, 34128
Site Reference ID/Investigator# 45422
Tuebingen, Germany, BW 72076
Site Reference ID/Investigator# 45427
Ulm, Germany, 89081
Site Reference ID/Investigator# 45435
Cassino, Italy, 03043
Site Reference ID/Investigator# 45436
Chieti Scalo, Italy, 66013
Site Reference ID/Investigator# 45437
Rome, Italy, 00163
Site Reference ID/Investigator# 45438
Coimbra, Portugal, 3000-075
Site Reference ID/Investigator# 45439
Lisbon, Portugal, 1649-035
Sponsors and Collaborators
Abbott Products
Study Director: Juliana Bronzova, MD Abbott Healthcare Products B.V.
More Information

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT00903838     History of Changes
Other Study ID Numbers: S308.2.008
2008-000400-81 ( EudraCT Number )
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents