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.

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.

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

Study Overview

• Status: Terminated
• Conditions: Advanced Stage Parkinson's Disease
• Intervention / Treatment: Drug: pardoprunox; Drug: pramipexole

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Goettingen, Germany, 37075
    • Site Reference ID/Investigator# 45433
  • Kassel, Germany, 34128
    • Site Reference ID/Investigator# 45428
  • Tuebingen, Germany, BW 72076
    • Site Reference ID/Investigator# 45422
  • Ulm, Germany, 89081
    • Site Reference ID/Investigator# 45427
• Italy
  • Cassino, Italy, 03043
    • Site Reference ID/Investigator# 45435
  • Chieti Scalo, Italy, 66013
    • Site Reference ID/Investigator# 45436
  • Rome, Italy, 00163
    • Site Reference ID/Investigator# 45437
• Portugal
  • Coimbra, Portugal, 3000-075
    • Site Reference ID/Investigator# 45438
  • Lisbon, Portugal, 1649-035
    • Site Reference ID/Investigator# 45439

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to endpoint in ON-time without dyskinesia	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4	16 weeks

Collaborators and Investigators

• Sponsor: Abbott Products
• Investigators: Study Director: Juliana Bronzova, MD, Abbott Healthcare Products B.V.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Estimate): August 26, 2011
• Last Update Submitted That Met QC Criteria: August 25, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dyskinesias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: S308.2.008; 2008-000400-81 (EudraCT Number)