Clinical trial NCT00903838: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Stage Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to endpoint in ON-time without dyskinesia
timeFrame: 16 weeks
Secondary outcomes:
measure: Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Site Reference ID/Investigator# 45433
city: Kassel
country: Germany
facility: Site Reference ID/Investigator# 45428
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 45422
city: Ulm
country: Germany
facility: Site Reference ID/Investigator# 45427
city: Cassino
country: Italy
facility: Site Reference ID/Investigator# 45435
city: Chieti Scalo
country: Italy
facility: Site Reference ID/Investigator# 45436
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 45437
city: Coimbra
country: Portugal
facility: Site Reference ID/Investigator# 45438
city: Lisbon
country: Portugal
facility: Site Reference ID/Investigator# 45439
Study officials:
affiliation: Abbott Healthcare Products B.V.
name: Juliana Bronzova, MD
role: STUDY_DIRECTOR
References: