- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097421
Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
March 14, 2014 updated by: Boehringer Ingelheim
Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
329
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
specialist care
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient with parkinsons disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8-12 weeks
|
Level of Adherence
Time Frame: 8-12 weeks
|
Points on Morisky scale
|
8-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Preference
Time Frame: 8-12 weeks
|
Patients were asked about their preference regarding frequency of intake (once daily or three times daily)
|
8-12 weeks
|
Adverse Events (AE) Considered Related to Observed Medication
Time Frame: 8-12 weeks
|
Some patients had not related AEs as well as related AEs.
|
8-12 weeks
|
Pramipexole (PPX) Dose
Time Frame: pre-treatment and after 8-12 weeks
|
mean Pramipexole (PPX) dose
|
pre-treatment and after 8-12 weeks
|
Clinical Global Impressions (CGI)
Time Frame: 8-12 weeks
|
Clinical Global Impression (CGI) scale at final visit
|
8-12 weeks
|
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.
|
8-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
March 25, 2010
First Submitted That Met QC Criteria
March 31, 2010
First Posted (Estimate)
April 1, 2010
Study Record Updates
Last Update Posted (Estimate)
April 11, 2014
Last Update Submitted That Met QC Criteria
March 14, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Dopamine Agonists
- Dopamine Agents
- Antioxidants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pramipexole
Other Study ID Numbers
- 248.674
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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