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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01097421
First received: March 25, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Parkinson Disease
Drug: Pramipexole Extended Release

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    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.

  • Level of Adherence [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    Points on Morisky scale


Secondary Outcome Measures:
  • Patient Preference [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    Patients were asked about their preference regarding frequency of intake (once daily or three times daily)

  • Adverse Events (AE) Considered Related to Observed Medication [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    Some patients had not related AEs as well as related AEs.

  • Pramipexole (PPX) Dose [ Time Frame: pre-treatment and after 8-12 weeks ] [ Designated as safety issue: No ]
    mean Pramipexole (PPX) dose

  • Clinical Global Impressions (CGI) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression (CGI) scale at final visit

  • Patients Global Impressions (PGI) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 329
Study Start Date: March 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with parkinsons disease Drug: Pramipexole Extended Release

  Eligibility

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

specialist care

Criteria

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).
  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: NCT01097421

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: NCT01097421     History of Changes
Other Study ID Numbers: 248.674
Study First Received: March 25, 2010
Results First Received: September 14, 2012
Last Updated: March 14, 2014
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014