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Completed

NCT Number: NCT01097421

Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
  • Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
  • Male or female PD patients aged at least 30
  • Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
  • Written informed consent by the patient for study participation.

Exclusion criteria

  • Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
  • Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).

Treatment and study plan

Pramipexole Extended Release

Drug

Primary outcomes

  1. Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment

    Time frame: 8-12 weeks

    Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.

  2. Level of Adherence

    Time frame: 8-12 weeks

    Points on Morisky scale

Secondary outcomes

  1. Patient Preference

    Time frame: 8-12 weeks

    Patients were asked about their preference regarding frequency of intake (once daily or three times daily)

  2. Adverse Events (AE) Considered Related to Observed Medication

    Time frame: 8-12 weeks

    Some patients had not related AEs as well as related AEs.

  3. Pramipexole (PPX) Dose

    Time frame: pre-treatment and after 8-12 weeks

    mean Pramipexole (PPX) dose

  4. Clinical Global Impressions (CGI)

    Time frame: 8-12 weeks

    Clinical Global Impression (CGI) scale at final visit

  5. Patients Global Impressions (PGI)

    Time frame: 8-12 weeks

    Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 1, 2010
Registry last updated
Apr 11, 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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