Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: pramipexole immediate release tablet; pramipexole extended release tablet
Intervention description: 0.375mg-4.5mg(daily dose), three times a day; 0.375mg-4.5mg, once a day
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 475.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to
      Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease
      Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female Chinese patient with idiopathic Parkinson's disease (PD) confirmed by
             at least two of the following signs: resting tremor, bradykinesia, rigidity.

          2. Parkinson's disease diagnosed for at least 2 years.

          3. Patients 30 years of age or older at the time of diagnosis.

          4. Modified Hoehn and Yahr stage of 2 to 4 at on-time.

          5. If a patient is treated with standard or controlled release Levodopa combined with a
             Dopa-Decarboxylase-inhibitor or with Levodopa combined with a
             Dopa-Decarboxylase-inhibitor/entacapone, the dosage should be optimised according to
             investigator's judgement, and stable for at least 4 weeks prior to baseline visit.

          6. If a patient treated with Levodopa combined with a Dopa-Decarboxylase-inhibitor has
             motor fluctuations, he should not have more than 6 hours of off-time every day during
             waking hours (documented on a patient diary completed for 2 consecutive days before
             baseline visit).

          7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory
             tests and other study procedures (in particular, after training, the patient should be
             able to recognise the off-time and on-time periods during waking hours and to record
             them accurately in the patient diary).

          8. Signed informed consent obtained before any study procedures are carried out (in
             accordance with International Conference on Harmonisation-Good Clinical Practice
             guidelines and local legislation).

        Exclusion criteria:

        Medical exclusions:

          1. Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine),
             metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases
             (e.g., progressive supranuclear palsy).

          2. Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
             [R96-2656].

          3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental
             Disorders (4th edition)criteria that could prevent compliance or completion of the
             study and/or put the patient at risk if he/she takes part in the study.

          4. History of psychosis, except history of drug induced hallucinations (provided the
             investigator considers that participation to the trial would not represent a
             significant risk for the patient).

          5. History of deep brain stimulation

          6. Clinically significant electrocardiogram abnormalities at screening visit, according
             to investigator's judgement.

          7. Clinically significant hypotension (i.e. supine systolic blood pressure < 90 mmHg)
             and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic
             hypotension associated with a decline >=20 mmHg in systolic blood pressure and a
             decline >= 10 mmHg in diastolic blood pressure, at one minute after standing compared
             with the previous supine systolic and diastolic blood pressure obtained after 5
             minutes of quiet rest) at screening or baseline visit.

          8. Malignant melanoma or history of previously treated malignant melanoma.

          9. Any other clinically significant disease, whether treated or not, that could put the
             patient at risk or could prevent compliance or completion of the study.

         10. Pregnancy (to be excluded by urine pregnancy test at screening visit) or
             breast-feeding.

         11. Sexually active female of childbearing potential (less than 6 months post-menopausal
             and not surgically sterilised) not using a medically approved method of birth control
             (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one
             month prior to the screening visit and throughout the study period (up to the
             follow-up visit).

         12. Serum levels of Aspartate Aminotransferase, Alanine Aminotransferase , alkaline
             phosphatases or total bilirubin > 2 Upper Limit of Normal (on screening lab test).

         13. Patients with a creatinine clearance < 50 mL/min/1.73m2 (estimated by the local lab /
             the investigator using the Modification of Diet in Renal Disease (MDRD), and
             calculated on screening lab test)