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Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinsons Disease in Routine Clinical Practice

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01061567
First received: December 24, 2009
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The general aim of this PMS study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinsons disease in routine clinical practice.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinsons Disease in Routine Clinical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary objective is to evaluate the safety of pramipexole extended release in patients with Parkinsons disease. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Coprimary endpoints: incidence of adverse events and proportion of withdrawals due to adverse events. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy; [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Unified Parkinsons Disease Rating Scale (UPDRS) Parts I and III scores (change from baseline to end of study of Parts I and III separately); [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Improvement (CGII) Responder rate (rated at least minimally improved); [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) of patient satisfaction (change from baseline to end of study); [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Morisky Medication Adherence Scale, MMAS-4 Item (change in score from baseline to end of study). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2085
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Male and female patients with Parkinson

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients

Criteria

Inclusion criteria:

Early and advanced idiopathic Parkinsons disease Male and female patients over 18 years of age Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Exclusion criteria:

Ongoing treatment with pramipexole ER

Exclusion criteria in line with the pramipexole ER SmPC:

In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061567

  Show 284 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 Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01061567     History of Changes
Other Study ID Numbers: 248.675
Study First Received: December 24, 2009
Last Updated: May 2, 2013
Health Authority: Austria: Medicines and Medical Devices Agency
Estonia: The State Agency of Medicine
Kazakhstan: Ethical Commission
Romania: Ministry of Public Health
Serbia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013