Risk of Melanoma Among Parkinson’s Disease Patients (TV1030-CNS-50024)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42749
• EU PAS number:
  EUPAS19909
• Study ID:
  42749
• Official title and acronym:
  Risk of Melanoma Among Parkinson’s Disease Patients (TV1030-CNS-50024)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study to evaluate the risk of malignant melanoma in individuals with Parkinson’s disease treated and not treated with rasagiline. The study will be implemented in the United States Medicare research database, using data from 2006 through 2015 among individuals aged 65 years or older. The study is designed to estimate the incidence rate of melanoma in new users of rasagiline (Cohort A), new users of other anti-Parkinson’s medications (Cohort B), new and prevalent users of other anti-Parkinson’s medications (Cohort C), and individuals without Parkinson’s disease (Cohort D). Melanoma incidence will be compared between Cohorts A and B, A and C, and C and D. Potential outcomes of melanoma identified in the claims database will be validated through review of medical records.
• Study status:
  Finalised

Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Planned: 10/03/2017

Actual: 10/03/2017

Study start date

Planned: 30/07/2017

Actual: 08/01/2018

Date of final study report

Planned: 21/10/2019

Actual: 31/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceutical LTD

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)