a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01361009
First received: May 23, 2011
Last updated: May 7, 2014
Last verified: June 2013
  Purpose

This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.


Condition Intervention
Parkinson Disease
Drug: pramipexole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of AE/SAE [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.


Secondary Outcome Measures:
  • Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) [ Time Frame: Baseline (Visit 1) and 12 weeks (Visit 3) ] [ Designated as safety issue: No ]
    Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).

  • The Dosage Related Information of Pramipexole at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    At enrollment, the distribution of patients in 3 pramipexole dosage categories.

  • The Dosage Related Information of Pramipexole at the End of Study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    At the end of study, the distribution of patients in 3 pramipexole dosage categories.


Enrollment: 2017
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pramipexole group
It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Drug: pramipexole
as prescibed by the investigator

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

3000

Criteria

Inclusion criteria:

  1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria
  2. Age: from 30 to 75 years old
  3. Stage I-IV of revised Hoehn-Yahr standards
  4. With current use of pramipexole
  5. Informed consent signed by every subject

Exclusion criteria:

  1. Diagnosis of Parkinson¿s syndrome
  2. Current use of psychotolytic medications
  3. Allergic to pramipexole or any other ingredient of pramipexole
  4. Female patients in pregnancy and lactation
  5. Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study
  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: NCT01361009

  Show 103 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01361009     History of Changes
Other Study ID Numbers: 248.682
Study First Received: May 23, 2011
Results First Received: January 31, 2013
Last Updated: May 7, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
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 August 28, 2014