Study to Assess the Safety and Effectiveness of NMRA-335140-501

Last updated: March 25, 2025
Sponsor: Neumora Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Depression (Major/severe)

Depression

Mood Disorders

Treatment

NMRA-335140

Clinical Study ID

NCT06029439
NMRA-335140-501
KOASTAL-LT
  • Ages 18-65
  • All Genders

Study Summary

This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), who provide informed consent, and who have no evidence of safety concerns that would preclude treatment with NMRA-335140 may be enrolled into this extension study.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Rollover participants are eligible for the study if the following inclusion criteria are met:

  • Completed a previous NMRA-335140 Phase 3 MDD study (NMRA-335140-301,NMRA-335140-302, or NMRA-335140-303) according to the completion definition in theparent study protocol.

  • Signed an informed consent form (ICF) for this study.

  • Willing to comply with the contraception requirements described in the inclusioncriteria of the parent study protocol.

  • Willing to comply with the concomitant medication/therapy restrictions described inthe exclusion criteria of the parent study protocol.

Exclusion

Key Exclusion Criteria:

Rollover participants are excluded from the study if any of the following exclusion criteria are met:

  • Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, FifthEdition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in theparent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any otherpsychotic disorder, or moderate or severe substance or alcohol use disorder [excluding nicotine]).

  • Considered to be at significant risk of suicide in the judgment of the Investigator.This includes participants who are actively suicidal (eg, any suicide attemptsduring the parent study) or are at serious suicidal risk as indicated by any currentsuicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit"version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinicalevaluation by the Investigator; or are homicidal, in the opinion of theInvestigator.

  • Non-adherent with study medication (took ≤70% of study drug over any 2-week visitinterval) or procedures during the parent study.

  • Experienced treatment emergent adverse events (TEAEs) considered related to thestudy medication from the parent study and judged by the Investigator to beclinically significant to render the participant ineligible for enrollment.

  • Have an abnormality on ocular examination that would prohibit continued studyparticipation as determined by the Investigator.

  • Use of disallowed concomitant medication or therapy that would have beenexclusionary in the parent study, may compromise the safety of the participant,and/or confound the interpretation of protocol assessments.

  • Considered by the Investigator to be inappropriate for any other reason.

Study Design

Total Participants: 650
Treatment Group(s): 1
Primary Treatment: NMRA-335140
Phase: 3
Study Start date:
November 10, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Neumora Investigator Site

    Botafago - Rio De Janeiro, Rio De Janeiro 22270-060
    Brazil

    Active - Recruiting

  • Neumora Investigator Site

    Cherven Bryag, Pleven 5980
    Bulgaria

    Active - Recruiting

  • Neumora Investigator Site

    Sofia, Sofia City 1408
    Bulgaria

    Active - Recruiting

  • Neumora Investigator Site

    Varosha, Targovishte 7700
    Bulgaria

    Active - Recruiting

  • Neumora Investigator Site

    Kardzhali, 6600
    Bulgaria

    Active - Recruiting

  • Neumora Investigator Site

    Pleven, 5800
    Bulgaria

    Completed

  • Neumora Investigator Site

    Varna, 9020
    Bulgaria

    Active - Recruiting

  • Neumora Investigator Site #1

    Varna, 9020
    Bulgaria

    Completed

  • Neumora Investigator Site

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Active - Recruiting

  • Neumora Investigator Site

    Markham, Ontario L3R 1A3
    Canada

    Active - Recruiting

  • Neumora Investigator Site

    Mississauga, Ontario L5L 1W8
    Canada

    Active - Recruiting

  • Neumora Investigator Site

    Toronto, Ontario M5S 1M2
    Canada

    Active - Recruiting

  • Neumora Investigator Site

    Santiago, Región Metropolitana De Santiago 7560356
    Chile

    Active - Recruiting

  • Neumora Investigator Site

    Antofagasta, 1270244
    Chile

    Active - Recruiting

  • Neumora Investigator Site

    Plzen 3, Plzeň 301 00
    Czechia

    Active - Recruiting

  • Neumora Investigator Site

    Praha 8, Prague 186 00
    Czechia

    Active - Recruiting

  • Neumora Investigator Site

    Kladno, South Bohemian 272 01
    Czechia

    Active - Recruiting

  • Neumora Investigator Site

    Prague, 109 00
    Czechia

    Completed

  • Neumora Investigator Site

    Helsinki, Etelä-Suomen Lääni 00100
    Finland

    Active - Recruiting

  • Neumora Investigator Site

    Turku, Etelä-Suomen Lääni 20520
    Finland

    Site Not Available

  • Neumora Investigator Site

    Oulu, Oulun Lääni 90100
    Finland

    Active - Recruiting

  • Neumora Investigator Site

    Douai, Hauts-de-France 59500
    France

    Active - Recruiting

  • Neumora Investigator Site

    Montpellier, Hérault 34295
    France

    Active - Recruiting

  • Neumora Investigator Site

    La Roche-sur-Yon, Vendée 85000
    France

    Active - Recruiting

  • Neumora Investigator Site

    Berlin, 10629
    Germany

    Active - Recruiting

  • Neumora Investigator Site

    Wrocław, Dolnoslaskie 50-414
    Poland

    Active - Recruiting

  • Neumora Investigator Site

    Bydgoszcz, Kujawsko-pomorskie 85-133
    Poland

    Active - Recruiting

  • Neumora Investigator Site

    Lublin, Lubelskie 20-582
    Poland

    Completed

  • Neumora Investigator Site

    Białystok, Podkarpackie 15-879
    Poland

    Active - Recruiting

  • Neumora Investigator Site

    Gdańsk, Pomorskie 80-438
    Poland

    Active - Recruiting

  • Neumora Investigator Site

    Suchy Las, Wielkopolskie 62-002
    Poland

    Active - Recruiting

  • Neumora Investigator Site

    Lund, Skåne Län 222 22
    Sweden

    Active - Recruiting

  • Neumora Investigator Site

    Stockholm, Stolkholm Ian 113 29
    Sweden

    Active - Recruiting

  • Neumora Investigator site

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Phoenix, Arizona 85012
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Bentonville, Arkansas 72712
    United States

    Active - Recruiting

  • Neumora Investigator site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Neumora Investigator site

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Cerritos, California 90703
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Glendale, California 91206
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Imperial, California 92251
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Irvine, California 92614
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Lafayette, California 94549
    United States

    Active - Recruiting

  • Neumora Investigator Site-1

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Neumora Investigator site

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Los Angeles, California 90015
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Orange, California 92868
    United States

    Site Not Available

  • Neumora Investigator Site-1

    Orange, California 92868
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Riverside, California 92506
    United States

    Site Not Available

  • Neumora Investigator Site

    San Jose, California 95124
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Santa Ana, California 92704
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Temecula, California 92591
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Torrance, California 90504
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Neumora Investigator Site

    Norwalk, Connecticut 06851
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Hallandale Beach, Florida 33009
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Neumora Investigator site

    Miami, Florida 33183
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Neumora Investigator Site-1

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Neumora Investigator site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami Springs, Florida 33166
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • Neumora Investigator Site-1

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Neumora Investigator site

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Atlanta, Georgia 30338
    United States

    Site Not Available

  • Neumora Investigator Site-1

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Chicago, Illinois 60634
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Warrenville, Illinois 60555
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Neumora Investigator Site

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Baltimore, Maryland 21208
    United States

    Active - Recruiting

  • Neumora Investigator site

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Boston, Massachusetts 02116
    United States

    Active - Recruiting

  • Neumora Investigator site

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Neumora Investigator site

    Springfield, Massachusetts 01103
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Neumora Investigator site

    Bloomfield Township, Michigan 48302
    United States

    Completed

  • Neumora Investigator Site

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Neumora Investigator Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Neumora Investigator Site

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Neumora Investigator site

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Brooklyn, New York 11224
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Cedarhurst, New York 11516
    United States

    Active - Recruiting

  • Neumora Investigator Site

    New York, New York 10029
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    New York, New York 10029
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Staten Island, New York 10310
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Dayton, Ohio 45417
    United States

    Active - Recruiting

  • Neumora Investigator Site

    North Canton, Ohio 44720
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Allentown, Pennsylvania 18104
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Neumora Investigator Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Austin, Texas 78737
    United States

    Active - Recruiting

  • Neumora Investigator site

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Wichita Falls, Texas 76309
    United States

    Completed

  • Neumora Investigator Site

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Neumora Investigator Site #1

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Everett, Washington 98201
    United States

    Active - Recruiting

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