Status:
COMPLETED
Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 I...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female Chinese patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- Parkinson's disease diagnosed for at least 2 years.
- Patients 30 years of age or older at the time of diagnosis.
- Modified Hoehn and Yahr stage of 2 to 4 at on-time.
- 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.
- 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).
- 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).
- 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:
- 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).
- Dementia, as defined by a Mini-Mental State Exam score \< 24 at screening visit \[R96-2656\].
- 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.
- 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).
- History of deep brain stimulation
- Clinically significant electrocardiogram abnormalities at screening visit, according to investigator's judgement.
- 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.
- Malignant melanoma or history of previously treated malignant melanoma.
- 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.
- Pregnancy (to be excluded by urine pregnancy test at screening visit) or breast-feeding.
- 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).
- Serum levels of Aspartate Aminotransferase, Alanine Aminotransferase , alkaline phosphatases or total bilirubin \> 2 Upper Limit of Normal (on screening lab test).
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT01191944
Start Date
August 1 2010
End Date
January 1 2012
Last Update
October 31 2014
Active Locations (20)
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1
248.671.86004 Boehringer Ingelheim Investigational Site
Beijing, China
2
248.671.86006 Boehringer Ingelheim Investigational Site
Beijing, China
3
248.671.86007 Boehringer Ingelheim Investigational Site
Beijing, China
4
248.671.86020 Boehringer Ingelheim Investigational Site
Beijing, China