Last updated: 03/29/2021 16:00:08
Post-marketing study of ropinirole prolonged release tablets in Parkinson’s disease: Evaluation outcomes associated with long term use of Ropinirole-PR using the clinical practice research datalink (CPRD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Post-marketing study of ropinirole prolonged release tablets in Parkinson’s disease: Evaluation outcomes associated with long term use of Ropinirole-PR using the clinical practice research datalink (CPRD)
Trial description: Parkinson’s disease (PD) is a neurodegenerative condition resulting in the deficiency of dopamine; current available therapies aim to compensate for its deficiency. Ropinirole is non-ergot dopamine agonists (DA) indicated for the treatment of PD. The immediate release formulation was approved over 15 years ago, a prolonged release (PR) formulation (ropinirole-PR) was more recently licensed in 2008. The proposed study is part of a post-marketing commitment to the Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate long term safety of ropinirole-PR. Specifically, it is proposed to estimate the incidence of dyskinesias, on-off phenomena (subject to feasibility) and impulse control disorders in PD patients initiating ropinirole-PR monotherapy vs. initiators of immediate release (IR) DA monotherapy. This retrospective observational study will use longitudinal electronic medical records from the United Kingdom (UK)- Clinical Practice Research Datalink (CPRD) supplemented with general physician (GP) questionnaire data. Treatment persistence and adherence to medication be also be evaluated. A propensity matched cohort design with adjustments for time varying covariates will be used. As requested by the MHRA, the extent of off-label use of ropinirole-PR will be estimated by evaluating the medical history of patients prescribed ropinirole-PR without a history of Parkinson’s disease using data captured in the CPRD.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence rate ratio of dyskinesia, on-off phenomena, and impulse control disorders in subjects initiating ropinirole-PR monotherapy versus those initiating immediate release dopamine agonist monotherapy
Timeframe: Follow-up will commence at date of initiation of treatment +30days (index date), upto a maximum of 5 years of treatment
Secondary outcomes:
Baseline characteristics of subjects initiating ropinirole-PR versus IR-DA monotherapy for PD
Timeframe: Follow-up will commence at date of initiation of treatment +30days (index date). Upto a maximum of 5 years of treatment
Treatment persistence and adherence (ropinirole-PR versus matched cohort IR-DA cohort)
Timeframe: Follow-up will commence at date of initiation of treatment +30days (index date). Upto a maximum of 5 years of treatment
Extent of off-label use amongst ropinirole-PR initiators
Timeframe: Medical history prior to initiation
Interventions:
Enrollment:
1
Primary completion date:
2018-30-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Usha Gungabissoon, Oksana Kirichek, Celine El Baou, Nicholas Galwey. Comparison of long-term use of prolonged-release ropinirole and immediate-release dopamine agonists in an observational study in patients with Parkinson’s disease. Pharmacoepidemiol Drug Saf. 2020;1-8
Usha Gungabissoon, Oksana Kirichek, Celine El Baou, Nicholas Galwey.Comparison of long-term use of prolonged-release ropinirole and immediate-release dopamine agonists in an observational study in patients with Parkinson’s disease .Pharmacoepidemiol Drug Saf.2020;29(5):591-598
DOI: 10.1002/pds.4986
PMID: 32153056
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
None
Study date(s)
April 2016 to April 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Primary/idiopathic Parkinsons disease patients.
- At least 12 months of registration prior to index date allow time for the recording of prevalent events
- Patients aged less than 40 years at the time of PD diagnosis.
- Drug induced Parkonsinism (code for drug induced PD or exposure to any prescription for drugs known to induce Parkinsonism in the 3 month period before PD diagnosis date).
Inclusion and exclusion criteria
Inclusion criteria:
- Primary/idiopathic Parkinsons disease patients.
- At least 12 months of registration prior to index date allow time for the recording of prevalent events
- Patients must be aged at least 40 years at the time of PD diagnosis.
- At least one prescription for a dopamine agonist of interest between 2004 and 2012 for treatment of PD.
Exclusion criteria:
- Patients aged less than 40 years at the time of PD diagnosis.
- Drug induced Parkonsinism (code for drug induced PD or exposure to any prescription for drugs known to induce Parkinsonism in the 3 month period before PD diagnosis date).
- Other secondary parkinsonism. (including Malignant Neuroleptic syndrome, Postencephalytic Parkinsonism, Vascular and Syphilitic Parkinsonisms) prior to index date.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-30-04
Actual study completion date
2018-30-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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