Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01097421
First received: March 25, 2010
Last updated: October 25, 2012
Last verified: October 2012
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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: | Observational Model: Cohort 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 Pharmaceuticals:
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 ]
- Clinical Global Impressions (CGI) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
- 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:
- 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).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | October 25, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 17, 2013