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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097421
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : November 26, 2012
Last Update Posted : April 11, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson Disease Drug: Pramipexole Extended Release

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Study Type : Observational
Actual Enrollment : 329 participants
Time Perspective: Prospective
Official Title: Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease
Study Start Date : March 2010
Actual Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patient with parkinsons disease Drug: Pramipexole Extended Release

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
specialist care

Inclusion criteria:

  1. 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
  2. Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
  3. Male or female PD patients aged at least 30
  4. Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
  5. Written informed consent by the patient for study participation.

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01097421

Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT01097421    
Other Study ID Numbers: 248.674
First Posted: April 1, 2010    Key Record Dates
Results First Posted: November 26, 2012
Last Update Posted: April 11, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents