Parkinson DiseaseNCT01097421
Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole Extended Release
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Sep 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: specialist care
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole Extended Release
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole Extended ReleaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Patient with parkinsons disease | Not described Receives: Drug: Pramipexole Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
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.
Measured: 8-12 weeks
Level of Adherence
Points on Morisky scale
Measured: 8-12 weeks
Secondary outcomes (5)
Patient Preference
Patients were asked about their preference regarding frequency of intake (once daily or three times daily)
Measured: 8-12 weeks
Adverse Events (AE) Considered Related to Observed Medication
Some patients had not related AEs as well as related AEs.
Measured: 8-12 weeks
Pramipexole (PPX) Dose
mean Pramipexole (PPX) dose
Measured: pre-treatment and after 8-12 weeks
Clinical Global Impressions (CGI)
Clinical Global Impression (CGI) scale at final visit
Measured: 8-12 weeks
Patients Global Impressions (PGI)
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.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097421
- Sponsor's protocol ID
- 248.674
- Status last verified
- Mar 2014
- First submitted
- 25 Mar 2010
- Last updated
- 11 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01097421
- Acronym / sponsor ID
- 248.674
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Posted 26 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with parkinsons disease | – | Drug: Pramipexole Extended Release |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- specialist care
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole Extended Release | Drug | Patient with parkinsons disease |
Primary outcome
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.
Level of Adherence
Time frame: 8-12 weeks
Points on Morisky scale
5 secondary outcomes
Patient Preference
Time frame: 8-12 weeks
Adverse Events (AE) Considered Related to Observed Medication
Time frame: 8-12 weeks
Pramipexole (PPX) Dose
Time frame: pre-treatment and after 8-12 weeks
Clinical Global Impressions (CGI)
Time frame: 8-12 weeks
Patients Global Impressions (PGI)
Time frame: 8-12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment (time frame: 8-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.