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Pivotal Study in Advanced Parkinsons Disease Patients
This study has been completed.
First Received: April 25, 2007   Last Updated: April 24, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00466167
  Purpose

The general aim of this trial is 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 qd, in comparison to placebo, in L-Dopa+ treated Parkinson patients with advanced PD and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole ER versus pramipexole IR will be done.

The efficacy of pramipexole IR will also be compared to placebo, for assay sensitivity.


Condition Intervention Phase
Parkinson Disease
Drug: Pramipexole
Phase III

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 L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

Resource links provided by NLM:


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: 18 - 33 Weeks ]

Secondary Outcome Measures:
  • Percentage off time Percentage on time all subscales CGI I PGI I UPDRS I, II, III and IV scores separately BDI PDSS PDQ 39 and EQ 5D L Dopa daily dose incidences of AEs vital signs and weight ESS MMSE safety lab [ Time Frame: 18 - 33 Weeks ]

Enrollment: 518
Study Start Date: April 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   32 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient with advanced idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
  2. Parkinsons disease diagnosed for at least 2 years.
  3. Patients 30 years of age or older at the time of diagnosis.
  4. Modified Hoehn and Yahr stage of 2 to 4 at on-time.
  5. Treatment with standard or controlled release L-Dopa+, or with L-Dopa+/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit.
  6. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).
  7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary.
  8. Signed informed consent obtained before any study procedures are carried out (in accordance with ICH-GCP guidelines and local legislation).

Exclusion Criteria:

  1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
  2. Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
  3. Any psychiatric disorder according to DSM-IV 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
  4. History of psychosis, except history of drug induced hallucinations
  5. History of deep brain stimulation
  6. Clinically significant ECG abnormalities at screening visit
  7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
  8. Malignant melanoma or history of previously treated malignant melanoma
  9. 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
  10. Pregnancy or breast-feeding
  11. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period
  12. Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN
  13. Patients with a creatinine clearance < 50 mL/min
  14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
  15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
  16. Any of the following drugs within 4 weeks prior to 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 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 (whichever is longer) prior to baseline visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466167

  Show 77 Study Locations
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: 248.525
Study First Received: April 25, 2007
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00466167     History of Changes
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna;   Czech Republic: SUKL (state institute for drug control);   Great Britain: MHRA;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   India: Drug Control General of India;   Italy: Comitato di Bioetica Az. Policlinico di Catania - CATANIA;   Korea, Republic of: Korea Food and Drug Administration (KFDA);   Philippines: Department of Health, Republic of the Philippines;   Poland: Registration Medicinal Product Medical Device Biocidal Product;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   Spain: Spanish Agency for Medicines and Health Products;   Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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 03, 2009