120
Participants
Start Date
May 27, 2025
Primary Completion Date
May 31, 2027
Study Completion Date
December 31, 2027
SKY-0515
"Study Drug Name (INN): SKY-0515 Type: Drug (small molecule) Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 12 months~Use: Experimental Sourcing: SKY-0515 will be provided centrally by the Sponsor or subsidiary, or designee Packaging and Labeling: Study drug will be provided in blinded bottles labeled as required per country requirement. All packaging and labeling operations for the study drug will be performed according to current Good Manufacturing Practice for Medicinal Products and the relevant regulatory requirements."
SKY-0515 Placebo
"Route of Administration: Oral Dosage~Frequency: Once daily~Blinded Treatment Duration: 12 months~Use: Experimental~Sourcing: SKY-0515 placebo will be provided centrally by the Sponsor or subsidiary, or designee~Packaging and Labeling: Study drug will be provided in blinded bottles labeled as required per country requirement. All packaging and labeling operations for the study drug will be performed according to current Good Manufacturing Practice for Medicinal Products and the relevant regulatory requirements"
RECRUITING
Auckland City Hospital, Auckland
RECRUITING
Westmead Hospital, Westmead
RECRUITING
John Hunter Hospital, New Lambton Heights
RECRUITING
The Royal Melbourne Hospital, Parkville
RECRUITING
Calvary Health Care Bethlehem, Caulfield South
RECRUITING
The University of Queensland, Herston
RECRUITING
Flinders Medical Centre, Adelaide
RECRUITING
The Perron Institute for Neurology and Translational Science (Perron Institute), Nedlands
RECRUITING
Wellington Hospital, Wellington
RECRUITING
Christchurch Neurology Trials Limited, Christchurch
Skyhawk Therapeutics, Inc.
INDUSTRY