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A 12-week Study of Pramipexole ER in Patients With Parkinson's Disease, Followed by a 52-week Long-term Treatment Period
This study is ongoing, but not recruiting participants.
First Received: November 16, 2007   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00560508
  Purpose

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 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).


Condition Intervention Phase
Parkinson Disease
Drug: Pramipexol Extended Release
Drug: Pramipexol Immediate Release
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
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 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • No primary efficacy endpoints are set up, because the primary objective of this trial is to compare safety, tolerability and trough plasma drug concentration.

Secondary Outcome Measures:
  • Double blind period: UPDRS parts II plus III score (change from baseline), Percentage off time during waking hours (change from baseline), Open label period: UPDRS parts II plus III score change from Visit 8 [ Time Frame: 65 weeks ]

Estimated Enrollment: 100
Study Start Date: November 2007
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 episodes
    • 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 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 judgment.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560508

Locations
Japan
248.610.001 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo, Japan
248.610.002 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan
248.610.004 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa, Japan
248.610.005 Boehringer Ingelheim Investigational Site
Okayama, Okayama, Japan
248.610.006 Boehringer Ingelheim Investigational Site
Aomori, Aomori, Japan
248.610.020 Boehringer Ingelheim Investigational Site
Akita, Akita, Japan
248.610.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan
248.610.003 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo, Japan
248.610.012 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
248.610.019 Boehringer Ingelheim Investigational Site
Akashi, Hyogo, Japan
248.610.015 Boehringer Ingelheim Investigational Site
Iwamizawa,Hokkaido, Japan
248.610.007 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi, Japan
248.610.008 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan
248.610.009 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto, Japan
248.610.017 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido, Japan
248.610.018 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido, Japan
248.610.011 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
248.610.010 Boehringer Ingelheim Investigational Site
Morioka, Iwate, Japan
248.610.014 Boehringer Ingelheim Investigational Site
Fuchu, Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.610
Study First Received: November 16, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00560508     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Neurotransmitter Agents
Levodopa
Ganglion Cysts
Antioxidants
Basal Ganglia Diseases
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pramipexol
Dopamine
Parkinson Disease
Movement Disorders
Dihydroxyphenylalanine
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009