ENCALM: En undersøgelse af ENX-102 som en monoterapibehandling hos patienter med generaliseret angstlidelse (ENCALM)
17. september 2026 opdateret af: Engrail Therapeutics INC
ENCALM Trial: Et randomiseret, dobbeltblindt, placebokontrolleret monoterapiforsøg til evaluering af effektiviteten og sikkerheden af ENX-102 hos patienter med generaliseret angstlidelse
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
252
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- IMA Clinical Research Phoenix
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California
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Garden Grove, California, Forenede Stater, 92845
- Collaborative Neuroscience Research, LLC (CNS)
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Imperial, California, Forenede Stater, 92251
- Sun Valley Research Center
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Long Beach, California, Forenede Stater, 90712
- Alliance Research
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Los Angeles, California, Forenede Stater, 90015
- NRC Research Institute
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Oceanside, California, Forenede Stater, 92056
- Excell Research, Inc.
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Redlands, California, Forenede Stater, 92374
- Anderson Clinical Research
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Sherman Oaks, California, Forenede Stater, 91403
- California Neuroscience Research, LLC
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Upland, California, Forenede Stater, 91786
- Pacific Clinical Research Management Group
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Walnut Creek, California, Forenede Stater, 94596
- Sunwise Clinical Research
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Colorado
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Denver, Colorado, Forenede Stater, 80209
- Mountain View Clinical Research
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Florida
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Clermont, Florida, Forenede Stater, 34711
- Vertex Clinical Research
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Jacksonville, Florida, Forenede Stater, 32256
- Clinical Neuroscience Solutions, Inc.
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Lakeland, Florida, Forenede Stater, 33803
- Accel Research Sites Network - Lakeland CRU
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Maitland, Florida, Forenede Stater, 32751
- Accel Research Sites Network - Maitland CRU
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Orlando, Florida, Forenede Stater, 32801
- Clinical Neuroscience Solutions, Inc.
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Georgia
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Savannah, Georgia, Forenede Stater, 31405
- CenExel iResearch, LLC
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Collective Medical Research
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Boston Clinical Trials
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Precise Research Centres
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- IMA Clinical Research
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New York
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Brooklyn, New York, Forenede Stater, 11235
- SPRI Clinical Trials, LLC
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Cedarhurst, New York, Forenede Stater, 11516
- Neurobehavioral Research
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Staten Island, New York, Forenede Stater, 10314
- Richmond Behavioral Associates
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119
- Clinical Neuroscience Solutions, Inc.
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Texas
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Austin, Texas, Forenede Stater, 78737
- Austin Clinical Trials Partners
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Dallas, Texas, Forenede Stater, 75231
- FutureSearch Trials of Dallas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Plano, Texas, Forenede Stater, 75093
- Aim Trials
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Wichita Falls, Texas, Forenede Stater, 76309
- Grayline Research Center
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Utah
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Clinton, Utah, Forenede Stater, 84015
- Alpine Research Organization
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Washington
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Everett, Washington, Forenede Stater, 98201
- Core Clinical Research
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
- Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
- Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1
Key Exclusion Criteria:
- Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
- Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
- Reports moderately severe to severe symptoms of depression
- Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
- Recent suicidal ideation or behavior
- Current or recent moderate to severe substance use disorder as assessed by the MINI
- Clinically significant abnormal findings in safety assessments
- Has significant progressive disorders or unstable medical conditions
- Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ENX-102
Four weeks of 2 mg of ENX-102 in capsule form followed by 3 weeks of tapered dose plus 2 weeks of placebo in capsule form (before and/or after the ENX-102 treatment period), taken orally once daily in the evening for a 9-week total treatment period. |
Selective GABA-A alpha2,3,5 positive allosteric modulator |
|
Placebo komparator: Placebo
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period. |
Placebo |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
Tidsramme: 4 weeks
|
Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score [14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes] |
4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Estibaliz Arce, PhD, Engrail Therapeutics INC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. juli 2023
Primær færdiggørelse (Faktiske)
18. september 2025
Studieafslutning (Faktiske)
18. september 2025
Datoer for studieregistrering
Først indsendt
18. februar 2023
Først indsendt, der opfyldte QC-kriterier
28. februar 2023
Først opslået (Faktiske)
1. marts 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENX-102-003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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