Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients

NCT ID: NCT01191944

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-01-31

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 II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

pramipexole Extended release

subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement

Group Type: EXPERIMENTAL

pramipexole extended release tablet

Intervention Type: DRUG

0.375mg-4.5mg, once a day

pramipexole Immediate release

subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement

Group Type: ACTIVE_COMPARATOR

pramipexole immediate release tablet

Intervention Type: DRUG

0.375mg-4.5mg(daily dose), three times a day

Interventions

pramipexole immediate release tablet

0.375mg-4.5mg(daily dose), three times a day

Intervention Type: DRUG

pramipexole extended release tablet

0.375mg-4.5mg, once a day

Intervention Type: DRUG

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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

248.671.86004 Boehringer Ingelheim Investigational Site

Beijing, , China

248.671.86006 Boehringer Ingelheim Investigational Site

Beijing, , China

248.671.86007 Boehringer Ingelheim Investigational Site

Beijing, , China

248.671.86020 Boehringer Ingelheim Investigational Site

Beijing, , China

248.671.86012 Boehringer Ingelheim Investigational Site

Chengdu, , China

248.671.86013 Boehringer Ingelheim Investigational Site

Chongqing, , China

248.671.86014 Boehringer Ingelheim Investigational Site

Chongqing, , China

248.671.86008 Boehringer Ingelheim Investigational Site

Guangzhou, , China

248.671.86009 Boehringer Ingelheim Investigational Site

Guangzhou, , China

248.671.86017 Boehringer Ingelheim Investigational Site

Hangzhou, , China

248.671.86018 Boehringer Ingelheim Investigational Site

Hangzhou, , China

248.671.86005 Boehringer Ingelheim Investigational Site

Jinan, , China

248.671.86002 Boehringer Ingelheim Investigational Site

Nanjing, , China

248.671.86001 Boehringer Ingelheim Investigational Site

Shanghai, , China

248.671.86003 Boehringer Ingelheim Investigational Site

Shanghai, , China

248.671.86010 Boehringer Ingelheim Investigational Site

Shanghai, , China

248.671.86011 Boehringer Ingelheim Investigational Site

Shenyang, , China

248.671.86019 Boehringer Ingelheim Investigational Site

Suzhou, , China

248.671.86015 Boehringer Ingelheim Investigational Site

Wuhan, , China

248.671.86016 Boehringer Ingelheim Investigational Site

Wuhan, , China

Countries

China

Other Identifiers

248.671

Identifier Type: -

Identifier Source: org_study_id