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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01061567
First received: December 24, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.


Condition
Parkinson's 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 Parkinson's Disease in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: From the treatment initiation to the end of study, on average 92.9 days ] [ Designated as safety issue: No ]
    The number of patients with any adverse events (AEs), patients with drug-related AEs.

  • Proportion of Patients With Withdrawals Due to Adverse Events. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Patients who discontinued treatment due to adverse events including deaths.


Secondary Outcome Measures:
  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score [ Time Frame: Baseline and the end of study (up to 16 weeks) ] [ Designated as safety issue: No ]
    Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.

  • Clinical Global Impression of Improvement (CGI-I) Responder Rate [ Time Frame: Baseline and the end of study (up to 16 weeks) ] [ Designated as safety issue: No ]
    The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.

  • Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction [ Time Frame: Baseline and the end of study (up to 16 weeks) ] [ Designated as safety issue: No ]
    The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.

  • Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score [ Time Frame: Baseline and the end of study (up to 16 weeks) ] [ Designated as safety issue: No ]
    The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement


Enrollment: 1814
Study Start Date: November 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Male and female patients with Parkinson's disease

  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 Parkinson's 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 284 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01061567     History of Changes
Other Study ID Numbers: 248.675
Study First Received: December 24, 2009
Results First Received: June 6, 2014
Last Updated: June 6, 2014
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 July 22, 2014