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) (111981)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40748
• EU PAS number:
  EUPAS12518
• Study ID:
  40748
• Official title and acronym:
  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) (111981)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Parkinson 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 DA indicated for the treatment of PD. The immediate release formulation was approved over 15 years ago, a prolonged release formulation (ropinirole-PR) was more recently licensed in 2008. The proposed study is part of a post-marketing commitment to the 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 DA monotherapy. This retrospective observational study will use longitudinal electronic medical records (EMR) from the UK- Clinical Practice Research Datalink (CPRD) supplemented with GP questionnaire data. Treatment persistence, adherence off-label use of ropinirole-PR will be also be evaluated. A propensity matched cohort design with adjustments for time varying covariates will be used.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 29/09/2015

Actual: 29/09/2015

Study start date

Planned: 31/03/2016

Actual: 07/04/2016

Date of final study report

Planned: 26/04/2018

Actual: 30/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-111981-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)