trial
as of 2026-07-01Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
NCTId NCT04987229
at a glance
Phase 3 · Enrolling By Invitation
Enrollment 236 (estimated)
Sponsored by Alkermes, Inc.
Primary completion 2027-09
Synthesized from structured facts only — each point cited above.
Design & status
Phase
Phase 3
Status
Enrolling By Invitation
Enrollment
236 (estimated)
Study type
Interventional
Allocation
Na
Model
Single Group
Masking
None
Start
2021-10-22
Primary completion
2027-09
Eligibility
ALL · 10 Years · 17 Years
Interventions & indications
Drugs
Indications
Sponsors
Alkermes, Inc.Lead Sponsor
Investigators
1
David McDonnell, MDStudy Director
Sites
35 total
Dothan, United StatesLittle Rock, United StatesStanford, United StatesWashington D.C., United StatesMiami Lakes, United StatesDecatur, United StatesChicago, United StatesIndianapolis, United StatesSaint Charles, United StatesLincoln, United StatesCincinnati, United StatesWest Chester, United States
Linked catalysts
1
Facts & assertions
4 sourced
Enrollment
236
Phase
PHASE3
Primary Completion Date
2027-09
Status
ENROLLING_BY_INVITATION
relationships
The graph out of here
drug
drug
lead_sponsor
company
indication
investigator
person