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

NCT01191944 | Completed Phase 3 Results

• 1 other identifier: 248.671
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 20

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18

  UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.

  Baseline and week 18

Secondary Outcomes (18)

• Change From Baseline in Percentage Off-time During Waking Hours at Week 18

  Baseline and week 18

• Change From Baseline in Duration of Off-time During Waking Hours at Week 18

  Baseline and week 18

• Responder in Percentage Off-time During Waking Hours at Week 18

  Baseline and week 18

• Change From Baseline in Percentage On-time Without Dyskinesia at Week 18

  Baseline and week 18

• Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18

  Baseline and week 18

Other Outcomes (1)

• Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks

  Baseline and week 18

Study Arms (2)

pramipexole Extended release

EXPERIMENTAL

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

Drug: pramipexole extended release tablet

pramipexole Immediate release

ACTIVE COMPARATOR

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

Drug: pramipexole immediate release tablet

Interventions

pramipexole immediate release tablet DRUG

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

pramipexole Immediate release

pramipexole extended release tablet DRUG

0.375mg-4.5mg, once a day

pramipexole Extended release

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (20)

248.671.86004 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.671.86006 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.671.86007 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.671.86020 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.671.86012 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

248.671.86013 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

248.671.86014 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

248.671.86008 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

248.671.86009 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

248.671.86017 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

248.671.86018 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

248.671.86005 Boehringer Ingelheim Investigational Site

Jinan, China

Location

248.671.86002 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

248.671.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.671.86003 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.671.86010 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.671.86011 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

248.671.86019 Boehringer Ingelheim Investigational Site

Suzhou, China

Location

248.671.86015 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

248.671.86016 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 31, 2014
• Results First Posted: January 24, 2013

Record last verified: 2014-10

Locations

CN (20)