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NCT Number: NCT01361009

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 54, Beijing, China

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About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosis of Parkinson¿s syndrome
  • Current use of psychotolytic medications
  • Allergic to pramipexole or any other ingredient of pramipexole
  • Female patients in pregnancy and lactation
  • 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

Treatment and study plan

Pramipexole

Drug

as prescibed by the investigator

Primary outcomes

  1. Incidence of AE/SAE

    Time frame: 12 weeks

    The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.

Secondary outcomes

  1. 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)

    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).

  2. The Dosage Related Information of Pramipexole at Baseline

    Time frame: baseline

    At enrollment, the distribution of patients in 3 pramipexole dosage categories.

  3. The Dosage Related Information of Pramipexole at the End of Study

    Time frame: 12 weeks

    At the end of study, the distribution of patients in 3 pramipexole dosage categories.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 26, 2011
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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