Phase 2 study of FNP 223 (oral formulation) in PSP
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, Phase 2 study to assess the efficacy, safety, and pharmacokinetics of FNP-223 (oral formulation) to slow the disease progression of progressive supranuclear palsy (PSP) (PROSPER)
IRAS ID
1009456
Contact name
Anna Colomé
Contact email
Sponsor organisation
Ferrer Internacional, S.A
Clinicaltrials.gov Identifier
Research summary
This study is a Phase 2 a randomized, double-blind, placebo-controlled study which will be conducted in approximately 220 male and female adult participants with progressive supranuclear palsy (PSP).
Participants with either be randomised to receive the study medication FNP-223 or the placebo to be taken orally three times a day.
The study will consist of a Screening Phase lasting up to 42 days during which participants will be assessed for eligibility, a Treatment Phase consisting of 52 weeks treatment and a 4 week follow up period.Participants will undergo site visits (Visit 1/Week 0/Day 1), Week 4 (Visit 3), Week 16 (Visit 6), Week 28 (Visit 8), Week 40 (Visit 10), and Week 52 (Visit 12). On Week 2 (Visit 2), Week 8 (Visit 4), Week 12 (Visit 5), Week 22 (Visit 7), Week 34 (Visit 9), Week 46 (Visit 11), and follow up on Week 56 (Visit 13), visit will be conducted telephonically.
During the course of the study, participants will undergo a number of different procedures including blood sampling, ECGs, MRIs (optional), Neurological and physical examinations and assessment of balance. Participants will be invited to consent to 2 optional lumbar punctures to collect Cerebrospinal fluid (CSF) at Visit 1 and Visit 8 or Visit 12. 4 mL of CSF would be collected per extraction. Prior to their consent, the study doctor access the participants to confirm if they are eligible to provide the CSF sample.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0042
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion