A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Healthy Volunteers: f
View:
• 25 years or older.
• Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).
• Total Functional Capacity (TFC) score of 10 or more).
• Total Motor Score (TMS) of 6 or more).
• Independence Score (IS) of 70 or more).
• Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.
• Men must agree to use birth control during the study and for 90 days after the last dose.
• Agree to sign a consent form and follow the study's rules and schedule.
Locations
United States
Colorado
CenExel Denver CO
NOT_YET_RECRUITING
Englewood
Other Locations
Argentina
Hospital El Cruce
RECRUITING
Buenos Aires
Buenos Aires British Hospital
RECRUITING
Caba
CINME Centro de Investigaciones Metabólicas
RECRUITING
Caba
IADIN (Instituto Argentino de Investigación Neurológica)
RECRUITING
Caba
Sanatorio Mater Dei
RECRUITING
Caba
Fundación Scherbovsky
RECRUITING
Mendoza
Brazil
Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH
ENROLLING_BY_INVITATION
Belo Horizonte
Hospital Angelina Caron
NOT_YET_RECRUITING
Campina Grande Do Sul
Instituto de Neurologia de Curitiba
RECRUITING
Curitiba
PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná
RECRUITING
Curitiba
Hospital Universitário Onofre Lopes (HUOL)
NOT_YET_RECRUITING
Natal
Faculdade de Medicina de Ribeirão Preto - FMRP
NOT_YET_RECRUITING
Ribeirão Preto
Hospital Universitario Pedro Ernesto (HUPE)
NOT_YET_RECRUITING
Rio De Janeiro
Hospital da Universidade Federal de São Paulo - UNIFESP