A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NIDO-361 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)
Status: Completed
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, and efficacy of NIDO-361 in adult patients with Spinal and Bulbar Muscular Atrophy (SBMA).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Ambulatory male
• Documented SBMA diagnosis confirmed by DNA genetic testing
• Able to complete six-minute walk test (6MWT)
Locations
Other Locations
Denmark
Rigshospitalet, Klinik for Nerve- og Muskelsygdomme & Copenhagen Neuromuscular Center
Copenhagen
Italy
IRCCS Istituto Neurologico Carlo Besta
Milan
Azienda Ospedale Università di Padova
Padua
Republic of Korea
Kyungpook National University Chilgok Hospital
Daegu
United Kingdom
University of College London Hospital (UCLH)
London
Time Frame
Start Date: 2024-03-01
Completion Date: 2025-10-22
Participants
Target number of participants: 54
Treatments
Experimental: NIDO-361
Participants receive 100 mg of NIDO-361 given orally once daily.
Placebo_comparator: Placebo
Participants receive matched dose placebo given orally once daily.
Related Therapeutic Areas
Sponsors
Leads: Nido Biosciences, Inc.