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NCT07002034

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from Reunion Neuroscience Inc

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Record History

All 16 versions: 16 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
    • Primary completion pushed from Nov 2026 to Apr 2027
    • Study completion pushed from Dec 2026 to May 2027
    • Study sites: 32 to 33
  2. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site contacts updated at 5 of 32 sites
  3. Study sites: 30 to 32v14
  4. Study sites revised (30)v13
  5. Study sites: 28 to 30v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 26 to 28v11
  2. Study sites: 25 to 26v10
  3. Study sites: 24 to 25v9
  4. Study sites: 22 to 24v8
  5. Study sites: 19 to 22v7
  6. Study sites: 17 to 19v6
  7. Study sites: 12 to 17
    • Secondary endpoints: details revised at 1 of 2 entries
    v5
  8. Study sites: 8 to 12v4
  9. Eligibility criteria expanded, about 1 word
    • Study sites: 5 to 8
    v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jun 2025 to Jul 30, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Timeframe: Day 7

Secondary (2)

RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

Arms and interventions

1.5 mg RE104Active comparator

A single subcutaneous injection of 1.5 mg RE104 for Injection

30 mg RE104Experimental

A single subcutaneous injection of 30 mg RE104 for Injection

Drugs: RE104 for Injection

Sites

33 sites in 1 country