Lupin PASS study
Research type
Research Study
Full title
An Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients with Non-dystrophic Myotonic Disorders
IRAS ID
282895
Contact name
Nikki Adetoro
Contact email
Sponsor organisation
Lupin Research Inc.
ISRCTN Number
NCT04616807
Clinicaltrials.gov Identifier
EU PAS Register, EUPAS37943
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a non-interventional, prospective, observational, multicentre study to evaluate the long-term safety and effectiveness of Namuscla in adult patients with non-dystrophic myotonic.
The study comprises of enrollment, on-treatment follow up at 12,24, 36 months , and follow up telephone calls at 6,18 and 30 months.
Patients will be enrolled over an approximate 2-year enrolment period and will be followed-up on-treatment for up to 3 years. The total study duration including enrolment period and data collection would be 5 years.
The study will target the enrolment of 50 patients who are treated with Namuscla. Approximately 6 specialized centres for myotonic disorders in the UK, Germany, and France.
REC name
North of Scotland Research Ethics Committee 2
REC reference
21/NS/0024
Date of REC Opinion
8 Mar 2021
REC opinion
Favourable Opinion