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Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00479401
  Purpose

The objectives of this trial conducted in early PD patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for UPDRS Parts II and III combined), safety, and tolerability of Pramipexole ER (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.

In addition, the efficacy of Pramipexole IR will be compared to placebo, for assay sensitivity


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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-Week Maintenance Phase in Patients With Early Parkinsons Disease (PD).

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint of the trial is the change from baseline to end of the maintenance period in UPDRS parts II+III score. [ Time Frame: 33 weeks ]

Secondary Outcome Measures:
  • Responder rate for Clinical Global Impression of Improvement Responder rate for Patient Global Impression of Improvement UPDRS I, II and III scores separately [ Time Frame: 33 weeks ]

Enrollment: 539
Study Start Date: May 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
  2. Parkinsons disease diagnosed within 5 years.
  3. Patients 30 years of age or older at the time of diagnosis.
  4. Modified Hoehn and Yahr stage of 1 to 3.
  5. Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrolment (screening visit, V1) according to the investigators judgement.

Exclusion Criteria:

  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
  3. Any psychiatric disorder according to DSM-IV
  4. History of psychosis
  5. Clinically significant electrocardiogram (ECG) abnormalities at screening visit
  6. Clinically significant hypotension
  7. Malignant melanoma or history of previously treated malignant melanoma
  8. 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
  9. Pregnancy
  10. Sexually active female of childbearing potential not using a medically approved method of birth control
  11. Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN
  12. Patients with a creatinine clearance < 50 mL/min
  13. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
  14. Total cumulative duration of prior exposure to Levodopa of more than 3 months.
  15. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
  16. Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
  17. Flunarizine within 3 months prior to baseline visit
  18. Known hypersensitivity to Pramipexole or its excipients
  19. Drug abuse (including alcohol), according to Investigators judgement, within 2 years prior to screening.
  20. Participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479401

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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.524, Eudract No 2007-000073-39
Study First Received: May 25, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00479401  
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica);   Austria: Federal Office for Safety in Health Care;   Czech Republic: SUKL (state institute for drug control);   Finland: National Agency for Medicines;   Germany: Federal Institute for Drugs and Medical Devices;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   India: Drug Control General of India;   Japan: Ministry of Health, Labor and Welfare;   Malaysia: Ministry of Health, Malaysia;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Slovakia: SUKL (state institute for drug control);   Taiwan: Department of Health, Executive Yuan, Taiwan;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Protective Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009