Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Alkermes, Inc.
Study ID
NCT04987229
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • OLZ/SAM — DRUG
    Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Study Details

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder

Key Dates

Start date
Oct 22, 2021
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
236 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All subjects
    All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 52 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
Alkermes Investigational SiteDothanAlabama36303-
Alkermes Investigational SiteLittle RockArkansas72204-
Alkermes Investigational SiteStanfordCalifornia94305-
Alkermes Investigational SiteWashington D.C.District of Columbia20010-
Alkermes Investigational SiteMiami LakesFlorida33016-
Alkermes Investigational SiteDecaturGeorgia30030-
Alkermes Investigational SiteChicagoIllinois60611-
Alkermes Investigational SiteIndianapolisIndiana46202-
Alkermes Investigational SiteSaint CharlesMissouri63304-
Alkermes Investigational SiteLincolnNebraska68526-
Alkermes Investigational SiteCincinnatiOhio45229-
Alkermes Investigational SiteWest ChesterOhio45069-
Alkermes Investigational SiteRichmondVirginia23220-
Alkermes Investigational SiteEverettWashington98201-

Find similar trials in Dothan, AL

By condition
Bipolar disorderSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Alkermes Investigational Site· Dothan, ALAlkermes Investigational Site· Little Rock, ARAlkermes Investigational Site· Stanford, CAAlkermes Investigational Site· Washington D.C., DCAlkermes Investigational Site· Miami Lakes, FLAlkermes Investigational Site· Decatur, GA

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