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.

This study has been terminated.
(The study was terminated on 31 May, 2011, due to strategic considerations.)
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00903838
First received: May 14, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Advanced Stage Parkinson's Disease
Drug: pardoprunox
Drug: pramipexole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change from baseline to endpoint in ON-time without dyskinesia [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pardoprunox
1.5 to 12 mg/day
Active Comparator: 2 Drug: pramipexole
0.75-4.5 mg/day

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903838

Locations
Germany
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
Italy
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
Portugal
Site Reference ID/Investigator# 45438
Coimbra, Portugal, 3000-075
Site Reference ID/Investigator# 45439
Lisbon, Portugal, 1649-035
Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Juliana Bronzova, MD Abbott Healthcare Products B.V.
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT00903838     History of Changes
Other Study ID Numbers: S308.2.008, 2008-000400-81
Study First Received: May 14, 2009
Last Updated: August 25, 2011
Health Authority: Italy: The Italian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:
Parkinson's disease

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

ClinicalTrials.gov processed this record on July 28, 2014