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ENIGMA-TRS 2NCT07184619

Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved 3 months later.

See at-risk trials from Newron Pharmaceuticals SPA

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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 19 words
    • Trial sites expanded: 19 → 25 locations
    • Secondary endpoints: details revised at 2 of 5 entries
    • Publications: details revised at 3 of 3 entries
  2. Primary and study completion pushed from Dec 31, 2026 to Mar 31, 2027
    • Trial sites expanded: 15 → 19 locations
    v8
  3. Trial sites expanded: 10 → 15 locationsv7
  4. Primary and study completion pushed from Sep 1, 2026 to Dec 31, 2026
    • Trial sites expanded: 5 → 10 locations
    v6
  5. Site details revised at 2 of 5 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 15, 2025 to Jan 23, 2026
    • Site details revised at 5 of 5 sites
    v4
  2. Interventions: Evenamide 15 mg BID (Drug), Placebo (Drug) to Evenamide 15 mg bid (Drug), Placebo (Drug)v3
  3. Eligibility criteria expanded, about 56 wordsv2 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Start date: Nov 1, 2025 to Oct 15, 2025
    • Interventions: Evenamide (Drug), Placebo (Drug) to Evenamide 15 mg BID (Drug), Placebo (Drug)
    • Secondary endpoints revised (5)
    • Site contacts updated at 5 of 5 sites
    • Study title expanded, about 1 word
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
Timeframe: From Baseline to Week 12
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Timeframe: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)

Secondary (5)

Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.
Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).

Arms and interventions

Evenamide 15 mg bidExperimental

Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment

PlaceboPlacebo comparator

Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Drugs: Evenamide 15 mg bid, Placebo

Sites

25 sites in 5 countries

Argentina 7, India 7, United States 5, Malaysia 4, Colombia 2