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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Pramipexole Immediate Release (Drug); Pramipexole Extended Release (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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).

Clinical Details

Official title: A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Experienced Adverse Events

Secondary outcome:

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

Change From Baseline in Percentage Off-time

Change From Baseline in Percentage On-time Without Dyskinesia

Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia

Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia

Change From Baseline in Percentage On-time With Troublesome Dyskinesia

Responder Rate For Clinical Global Impression of Improvement (CGI-I)

Responder Rate For Patient Global Impression of Improvement (PGI-I)

Change From Baseline in UPDRS Part I Score

Change From Baseline in UPDRS Part II Score

Change From Baseline in UPDRS Part III Score

Change From Baseline in UPDRS Part IV Score

UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)

Change From Baseline in L-dopa Daily Dose

Trough Plasma Concentration at Steady State

Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment

Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)

Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)

Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)

Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)

UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)

Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)

Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)

Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)

Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)

Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)

Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)

Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)

Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)

Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)

Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: November 2007
Last updated: July 29, 2014

Page last updated: August 23, 2015

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