Trials / Completed
CompletedNCT05679908
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Tonix Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNX-1900 | Patients will spray TNX-1900 once into each nostril. |
| DRUG | Placebo Nasal Spray | Patients will spray placebo nasal spray once into each nostril. |
Timeline
- Start date
- 2022-12-06
- Primary completion
- 2023-10-08
- Completion
- 2023-10-23
- First posted
- 2023-01-11
- Last updated
- 2025-02-25
- Results posted
- 2025-02-25
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05679908. Inclusion in this directory is not an endorsement.