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
Finalized
Finalized
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:
Drug: Immediate release dopamine agonists
Drug: Ropinirole-PR
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2018-30-04
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)
No location data available.
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
Finalized
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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