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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.

Primary Purpose

Advanced Stage Parkinson's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pardoprunox
pramipexole
Sponsored by
Abbott Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Stage Parkinson's Disease focused on measuring Parkinson's disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 45433
  • Site Reference ID/Investigator# 45428
  • Site Reference ID/Investigator# 45422
  • Site Reference ID/Investigator# 45427
  • Site Reference ID/Investigator# 45435
  • Site Reference ID/Investigator# 45436
  • Site Reference ID/Investigator# 45437
  • Site Reference ID/Investigator# 45438
  • Site Reference ID/Investigator# 45439

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to endpoint in ON-time without dyskinesia

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

Full Information

First Posted
May 14, 2009
Last Updated
August 25, 2011
Sponsor
Abbott Products
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1. Study Identification

Unique Protocol Identification Number
NCT00903838
Brief Title
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.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated on 31 May, 2011, due to strategic considerations.
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Products

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Stage Parkinson's Disease
Keywords
Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pardoprunox
Intervention Description
1.5 to 12 mg/day
Intervention Type
Drug
Intervention Name(s)
pramipexole
Intervention Description
0.75-4.5 mg/day
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in ON-time without dyskinesia
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Bronzova, MD
Organizational Affiliation
Abbott Healthcare Products B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45433
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Site Reference ID/Investigator# 45428
City
Kassel
ZIP/Postal Code
34128
Country
Germany
Facility Name
Site Reference ID/Investigator# 45422
City
Tuebingen
ZIP/Postal Code
BW 72076
Country
Germany
Facility Name
Site Reference ID/Investigator# 45427
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Site Reference ID/Investigator# 45435
City
Cassino
ZIP/Postal Code
03043
Country
Italy
Facility Name
Site Reference ID/Investigator# 45436
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Site Reference ID/Investigator# 45437
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
Site Reference ID/Investigator# 45438
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Site Reference ID/Investigator# 45439
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal

12. IPD Sharing Statement

Learn more about this trial

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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