Enrolling by invitation NCT06922110
An Open-Label Study of Azetukalner in Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azetukalner.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Finland, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
Overview
X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
Interventions
- Drug Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Primary outcome measures
- Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest [Time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose]
Secondary outcome measures (5)
- Change from baseline in the Hamilton Depression Rating Scale, 17-Item (HAMD-17) total score over time [Time frame: From baseline through the active extension treatment (Week 52)]
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time [Time frame: From baseline through the active extension treatment (Week 52)]
- Change in the Clinical Global Impression of Severity (CGI-S) score over time [Time frame: From baseline through the active extension treatment (Week 52)]
- Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores over time [Time frame: From baseline through the active extension treatment (Week 52)]
- Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores over time [Time frame: From baseline through the active extension treatment (Week 52)]
Eligibility criteria
Inclusion criteria
- Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD.
- Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
- Participant is willing to comply with the contraception requirements.
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
Exclusion criteria
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
- Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
- Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 66 centers
- Ima Clinical Research - Phoenix — Phoenix
- Sanro Clinical Research Group, Llc — Bryant
- Woodland International Research Group — Little Rock
- Woodland Research Northwest — Rogers
- Cenexel Cit - Bellflower — Bellflower
- Calneuro Research Group, Inc. — Los Angeles
- Excell Research Inc. — Oceanside
- Atp Clinical Research — Orange
- … and 58 more centers
Finland · 1 center
- Oulu Mentalcare Oy — Oulu
Poland · 1 center
- Praktyka Lekarska Malgorzata Wojtanowska-Bogacka - Centrum Badań Klinicznych — Poznan
Identifiers
NCT: NCT06922110 · XPF-010-D303