A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

NCT ID: NCT00560508

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

Brief Summary

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Conditions

Parkinson Disease

Study Design

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

Study Groups

Pramipexole Extended Release

patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID

Group Type: EXPERIMENTAL

Pramipexole Extended Release

Intervention Type: DRUG

titration as individually needed (0.375 mg -4.5 mg daily)

Pramipexole Immediate Release

patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -\> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID

Group Type: ACTIVE_COMPARATOR

Pramipexole Immediate Release

Intervention Type: DRUG

titrated as individually needed (0.25 mg - 4.5 mg daily)

Interventions

Pramipexole Immediate Release

titrated as individually needed (0.25 mg - 4.5 mg daily)

Intervention Type: DRUG

Pramipexole Extended Release

titration as individually needed (0.375 mg -4.5 mg daily)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.

2. Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.

3. Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).

4. Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:

• wearing-off phenomena
• no on /delayed on
• dystonia at off time
• on-off phenomena
• freezing phenomena at off time
• the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy

Exclusion Criteria

1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.

2. Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening visit.

3. Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.

4. History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).

5. Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.

6. Clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc 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) either at screening visit or at baseline visit.

7. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.

8. Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.

9. Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.

10. Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal .

11. Patients with a creatinine clearance <50 mL/min

12. Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.

• Minimum Eligible Age: 1 Year
• 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

248.610.019 Boehringer Ingelheim Investigational Site

Akashi, Hyogo, , Japan

248.610.020 Boehringer Ingelheim Investigational Site

Akita, Akita, , Japan

248.610.006 Boehringer Ingelheim Investigational Site

Aomori, Aomori, , Japan

248.610.017 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, , Japan

248.610.018 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, , Japan

248.610.001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

248.610.014 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, , Japan

248.610.011 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

248.610.015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, , Japan

248.610.003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, , Japan

248.610.008 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

248.610.021 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

248.610.010 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

248.610.005 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

248.610.012 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

248.610.004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

248.610.009 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, , Japan

248.610.007 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, , Japan

248.610.002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

Countries

Japan

Other Identifiers

248.610

Identifier Type: -

Identifier Source: org_study_id