At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
TNX-1900 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-blind, Randomized, Multicenter, Placebo-controlled, Three Arm Parallel Study to Evaluate the Efficacy and Safety of TNX-1900 (Intranasal Oxytocin) in Patients With Chronic Migraine (PREVENTION Study)
In Brief
A Phase 2 clinical trial evaluating TNX-1900 and Placebo Nasal Spray for Chronic Migraine and 3 related conditions. Completed, enrolled 88 participants across 26 sites.
Detailed Summary
This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine
CountriesUnited States
CollaboratorsPremier
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartDec 2022
First PostedJan 2023
Primary CompletionOct 2023
Study CompletionOct 2023
TodayJul 2026
First PostedJan 11, 2023
Enrollment StartDec 6, 2022
Primary CompletionOct 8, 2023
Study CompletionOct 23, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.5 years ago
Interventions
TNX-1900drug
Patients will spray TNX-1900 once into each nostril.
Placebo Nasal Spraydrug
Patients will spray placebo nasal spray once into each nostril.