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

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (35)v18 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 36 to 35v17
  3. Re-verified, no change to tracked fieldsv16
  4. Study sites: 40 to 36v15
  5. Study sites: 41 to 40v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites revised (41)v13 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 40 to 41v12
  3. Study sites: 41 to 40v11
  4. Study sites: 43 to 41v10
  5. Study sites: 41 to 43v9
  6. Study sites revised (41)v8 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 42 to 41v7
  8. Study sites: 4 to 42v6
  9. Study sites: 3 to 4v5
  10. Study sites: 2 to 3v4
  11. Study sites: 1 to 2 Start date changed from estimate of Oct 2021 to Oct 22, 2021v3 Show 1 more changeShow less
    • Start date changed from estimate of Oct 2021 to Oct 22, 2021
  12. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date: Aug 2021 to Oct 2021 · Study sites: 0 to 1 · Study title expanded, about 1 wordv2 Show 3 more changesShow less
    • Start date: Aug 2021 to Oct 2021
    • Study sites: 0 to 1
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Alkermes
10 trials monitored
See 1 trial at risk
Schizophrenia
685 trials monitored
See 32 trials at risk
Bipolar Disorder
388 trials monitored
See 23 trials at risk
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Trial Details
NCT Number NCT04987229
Lead Sponsor Alkermes, Inc.
Conditions Bipolar I Disorder, Schizophrenia
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov