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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

NCT01336088

Parkinson's Disease

COMPLETED PHASE2

A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease

NCT01494532

Parkinson Disease

COMPLETED PHASE4

Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

NCT00823836

Parkinson Disease

COMPLETED PHASE3

Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

NCT00368108

Parkinson's Disease

COMPLETED PHASE3

Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

NCT00505622

Parkinson's Disease

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Stage Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

pardoprunox

Intervention Type DRUG

1.5 to 12 mg/day

2

Group Type ACTIVE_COMPARATOR

pramipexole

Intervention Type DRUG

0.75-4.5 mg/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pardoprunox

1.5 to 12 mg/day

Intervention Type DRUG

pramipexole

0.75-4.5 mg/day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)