Exenatide Once-weekly as a Treatment for Multiple System Atrophy
Status:
Recruiting
Trial end date:
2022-04-26
Target enrollment:
Participant gender:
Summary
Fifty patients with early stage Multiple System Atrophy (MSA) will be recruited and
randomised to receive Exenatide injections, or to act as controls in this open label trial.
For half of the patients, Exenatide will be given as a once weekly subcutaneous injection in
addition to participant's regular medication. All patients will continue to receive standard
of care treatment for MSA. Detailed assessments will be made of all patients at baseline and
periodically for a total of 48 weeks. The primary endpoint will be the difference in total
Uniļ¬ed Multiple System Atrophy Rating Scale (UMSARS) score (Parts I and II) at 48 weeks
comparing Exenatide treated to best medically treated patients (controls). Secondary measures
will include adverse event reports, self-completed questionnaires, and blood test results.
Aside from these assessments, all patients will continue any regular MSA medications
throughout the trial with adjustments made only according to clinical need.
Standard of care treatment for patients on non IMP arm will be dependant on the patients
individual symptoms - there is no broad standard treatment for every patient.