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:
Abbott Products
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
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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
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 May 21, 2013