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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00903838

Enrollment

Registered

2009-05-18

Start date

2009-09-30

Completion date

2011-05-31

Last updated

2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Stage Parkinson's Disease

Keywords

Parkinson's disease

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.

Interventions

DRUGpardoprunox

1.5 to 12 mg/day

DRUGpramipexole

0.75-4.5 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany, Italy, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026