Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05679908 | A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine | PHASE2 | COMPLETED | 88 | — | — | Dec 6, 2022 | Oct 23, 2023 | Feb 25, 2025 | 26 | United States |
Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.
| Arm | Type | Description |
|---|---|---|
| TNX-1900 High Dose | EXPERIMENTAL | 30 IU oxytocin taken intranasally twice daily. |
| TNX-1900 Low Dose | EXPERIMENTAL | 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. |
| Placebo | PLACEBO_COMPARATOR | Placebo taken intranasally twice daily. |
| Name | Type | Description |
|---|---|---|
| TNX-1900 | DRUG | Patients will spray TNX-1900 once into each nostril. |
| Placebo Nasal Spray | DRUG | Patients will spray placebo nasal spray once into each nostril. |
Major Inclusion Criteria: * Men and women aged 18 to 65 years, inclusive, at the time of Visit 1. * History of migraine with or without aura for at least 1 year and onset at \< 50 years of age. Patient must also have a history of chronic migraine \> 3 months prior to Visit 1 as defined by IHS ICHD-...