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Completed

NCT Number: NCT01061567

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Bad Ischl, Austria

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: From the treatment initiation to the end of study, on average 92.9 days

    The number of patients with any adverse events (AEs), patients with drug-related AEs.

  2. Proportion of Patients With Withdrawals Due to Adverse Events.

    Time frame: 16 weeks

    Patients who discontinued treatment due to adverse events including deaths.

Secondary outcomes

  1. 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)

    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.

  2. Clinical Global Impression of Improvement (CGI-I) Responder Rate

    Time frame: Baseline and the end of study (up to 16 weeks)

    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.

  3. Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction

    Time frame: Baseline and the end of study (up to 16 weeks)

    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.

  4. Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score

    Time frame: Baseline and the end of study (up to 16 weeks)

    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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2010
Registry last updated
Jul 8, 2014

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

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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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