Clinical trial NCT01191944: Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
Official title: A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-08-31
Enrollment: 475
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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)

Primary outcomes:
measure: Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
timeFrame: Baseline and week 18
Secondary outcomes:
measure: Change From Baseline in Percentage Off-time During Waking Hours at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Duration of Off-time During Waking Hours at Week 18
timeFrame: Baseline and week 18
measure: Responder in Percentage Off-time During Waking Hours at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Duration of On-time Without Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18
timeFrame: Baseline and week 18
measure: Clinical Global Impression of Improvement (CGI-I) Responder at Week 18
timeFrame: 18 weeks
measure: Patient Global Impressions of Improvement (PGI-I) Responder at Week 18
timeFrame: 18 weeks
measure: Responder in UPDRS Parts II+III Score at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in UPDRS II Score Separately at Week 18
timeFrame: Baseline and week 18
measure: Change From Baseline in UPDRS III Score Separately at Week 18
timeFrame: Baseline and week 18
measure: Levodopa (L-Dopa) Introduction During the Study
timeFrame: 18 weeks
measure: Levodopa (L-Dopa) Dose Change During the Study
timeFrame: 18 weeks
Other outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks
timeFrame: Baseline and week 18
Locations:
city: Beijing
country: China
facility: 248.671.86004 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 248.671.86006 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 248.671.86007 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 248.671.86020 Boehringer Ingelheim Investigational Site
city: Chengdu
country: China
facility: 248.671.86012 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 248.671.86013 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 248.671.86014 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 248.671.86008 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 248.671.86009 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 248.671.86017 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 248.671.86018 Boehringer Ingelheim Investigational Site
city: Jinan
country: China
facility: 248.671.86005 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 248.671.86002 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 248.671.86001 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 248.671.86003 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 248.671.86010 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 248.671.86011 Boehringer Ingelheim Investigational Site
city: Suzhou
country: China
facility: 248.671.86019 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 248.671.86015 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 248.671.86016 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: