Clinical trial NCT06029439: Study to Assess the Safety and Effectiveness of NMRA-335140-501
Official title: Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
NMRA-335140
Long-term
Safety
Efficacy
Navacaprant
NMRA335140
NMRA 335140
Lead sponsor: Neumora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.


Eligibility criteria: 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 (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
* Signed an informed consent form (ICF) for this study.
* Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
* Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.

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, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic 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 attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal 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 clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
* Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
* Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
* Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
* Use of disallowed concomitant medication or therapy that would have been exclusionary 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.

Primary outcomes:
measure: Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales
timeFrame: Up to 54 Weeks
Secondary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time.
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in PHQ-9 Anhedonia Item #1 over time.
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.
timeFrame: Baseline and up to Week 54
measure: Change from Baseline in the Clinical Global Impression Scale of Severity (CGI-S)
timeFrame: Baseline and up to Week 54
measure: Clinical Global Impression Scale of Improvement (CGI-I) score at each timepoint
timeFrame: Baseline and up to Week 54
measure: Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from Baseline over time
timeFrame: Up to Week 54
measure: Percentage of participants whose MADRS total score decreased to 10 or less over time
timeFrame: Up to Week 54
measure: Change from baseline in the Sheehan Disability Scale (SDS) over time
timeFrame: Baseline and up to Week 54
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Neumora Investigator site
state: Alabama
city: Phoenix
country: United States
facility: Neumora Investigator Site
state: Arizona
city: Bentonville
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Little Rock
country: United States
facility: Neumora Investigator site
state: Arkansas
city: Rogers
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Bellflower
country: United States
facility: Neumora Investigator site
state: California
city: Cerritos
country: United States
facility: Neumora Investigator Site
state: California
city: Garden Grove
country: United States
facility: Neumora Investigator Site
state: California
city: Glendale
country: United States
facility: Neumora Investigator Site
state: California
city: Imperial
country: United States
facility: Neumora Investigator Site
state: California
city: Irvine
country: United States
facility: Neumora Investigator Site
state: California
city: Lafayette
country: United States
facility: Neumora Investigator Site
state: California
city: Long Beach
country: United States
facility: Neumora Investigator Site-1
state: California
city: Long Beach
country: United States
facility: Neumora Investigator site
state: California
city: Los Angeles
country: United States
facility: Neumora Investigator Site
state: California
city: Newport Beach
country: United States
facility: Neumora Investigator Site
state: California
city: Oceanside
country: United States
facility: Neumora Investigator Site
state: California
city: Orange
country: United States
facility: Neumora Investigator Site-1
state: California
city: Orange
country: United States
facility: Neumora Investigator Site
state: California
city: Riverside
country: United States
facility: Neumora Investigator Site
state: California
city: San Jose
country: United States
facility: Neumora Investigator Site
state: California
city: Santa Ana
country: United States
facility: Neumora Investigator Site
state: California
city: Sherman Oaks
country: United States
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state: California
city: Temecula
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Norwalk
country: United States
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state: Connecticut
city: Bradenton
country: United States
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state: Florida
city: Brandon
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Hallandale Beach
country: United States
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state: Florida
city: Hialeah
country: United States
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city: Hialeah
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Lauderhill
country: United States
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state: Florida
city: Maitland
country: United States
facility: Neumora Investigator Site #1
state: Florida
city: Maitland
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Lakes
country: United States
facility: Neumora Investigator site
state: Florida
city: Miami Lakes
country: United States
facility: Neumora Investigator Site #2
state: Florida
city: Miami Lakes
country: United States
facility: Neumora Investigator Site-1
state: Florida
city: Miami Springs
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site-1
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pembroke Pines
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pompano Beach
country: United States
facility: Neumora Investigator Site #1
state: Florida
city: Pompano Beach
country: United States
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state: Florida
city: Tampa
country: United States
facility: Neumora Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Neumora Investigator Site-1
state: Georgia
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Decatur
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Chicago
country: United States
facility: Neumora Investigator Site
state: Illinois
city: Warrenville
country: United States
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state: Illinois
city: Marrero
country: United States
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state: Louisiana
city: New Orleans
country: United States
facility: Neumora Investigator Site
state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Towson
country: United States
facility: Neumora Investigator site
state: Maryland
city: Boston
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Boston
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Methuen
country: United States
facility: Neumora Investigator site
state: Massachusetts
city: Springfield
country: United States
facility: Neumora Investigator site
state: Massachusetts
city: Watertown
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Bloomfield Township
country: United States
facility: Neumora Investigator site
state: Michigan
city: Flowood
country: United States
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state: Mississippi
city: Saint Charles
country: United States
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city: Saint Louis
country: United States
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state: Missouri
city: Las Vegas
country: United States
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state: Nevada
city: Berlin
country: United States
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state: New Jersey
city: Princeton
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city: Toms River
country: United States
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state: New Jersey
city: Bronx
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state: New York
city: Brooklyn
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city: Cedarhurst
country: United States
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state: New York
city: Inwood
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Charlotte
country: United States
facility: Neumora Investigator Site
state: North Carolina
city: Monroe
country: United States
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state: North Carolina
city: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: North Canton
country: United States
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state: Ohio
city: Edmond
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Allentown
country: United States
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state: Pennsylvania
city: Media
country: United States
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state: Pennsylvania
city: Memphis
country: United States
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state: Tennessee
city: Austin
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state: Texas
city: Austin
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facility: Neumora Investigator site
state: Texas
city: Fort Worth
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Wichita Falls
country: United States
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state: Texas
city: Bellevue
country: United States
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state: Washington
city: Everett
country: United States
facility: Neumora Investigator Site
state: Washington
city: Curitiba
country: Brazil
facility: Neumora Investigator Site
state: Paraná
city: Botafago - Rio De Janeiro
country: Brazil
facility: Neumora Investigator Site
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Neumora Investigator Site
state: Rio Grande Do Sul
city: Santa Cecília
country: Brazil
facility: Neumora Investigator Site
state: São Paulo
city: São Paulo
country: Brazil
facility: Neumora Investigator Site
city: Cherven Bryag
country: Bulgaria
facility: Neumora Investigator Site
state: Pleven
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Varosha
country: Bulgaria
facility: Neumora Investigator Site
state: Targovishte
city: Kardzhali
country: Bulgaria
facility: Neumora Investigator Site
city: Pleven
country: Bulgaria
facility: Neumora Investigator Site
city: Varna
country: Bulgaria
facility: Neumora Investigator Site
city: Kelowna
country: Canada
facility: Neumora Investigator Site
state: British Columbia
city: Markham
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Mississauga
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Toronto
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Antofagasta
country: Chile
facility: Neumora Investigator Site
city: Plzen 3
country: Czechia
facility: Neumora Investigator Site
state: Plzeň
city: Praha 8
country: Czechia
facility: Neumora Investigator Site
state: Prague
city: Kladno
country: Czechia
facility: Neumora Investigator Site
state: South Bohemian
city: Kladno
country: Czechia
facility: Neumora Investigator Site
city: Prague
country: Czechia
facility: Neumora Investigator Site
city: Helsinki
country: Finland
facility: Neumora Investigator Site
state: Etelä-Suomen Lääni
city: Turku
country: Finland
facility: Neumora Investigator Site
state: Etelä-Suomen Lääni
city: Oulu
country: Finland
facility: Neumora Investigator Site
state: Oulun Lääni
city: Clermont-Ferrand Cedex 1
country: France
facility: Neumora Investigator Site
state: Auvergne-Rhone-Alpes
city: Douai
country: France
facility: Neumora Investigator Site
state: Hauts-de-France
city: Montpellier
country: France
facility: Neumora Investigator Site
state: Hérault
city: La Roche-sur-Yon
country: France
facility: Neumora Investigator Site
state: Vendée
city: Poitiers
country: France
facility: Neumora Investigator Site
state: Vienne
city: Berlin
country: Germany
facility: Neumora Investigator Site #1
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Hamburg
country: Germany
facility: Neumora Investigator Site
city: Wrocław
country: Poland
facility: Neumora Investigator Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Neumora Investigator Site
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Neumora Investigator Site
state: Lubelskie
city: Lublin
country: Poland
facility: Neumora Investigator Site
state: Lubelskie
city: Białystok
country: Poland
facility: Neumora Investigator Site
state: Podkarpackie
city: Gdańsk
country: Poland
facility: Neumora Investigator Site
state: Pomorskie
city: Suchy Las
country: Poland
facility: Neumora Investigator Site
state: Wielkopolskie
city: Lund
country: Sweden
facility: Neumora Investigator Site
state: Skåne Län
city: Stockholm
country: Sweden
facility: Neumora Investigator Site
state: Stolkholm Ian
Study officials:
References: