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A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

NCT05679908 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-02-25

Study results available
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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

  • Chronic Migraine
  • Chronic Migraine, Headache
  • Chronic Migraine Without Aura
  • Aura Migraine

Interventions

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.

Sponsors & Collaborators

  • Premier

    collaborator UNKNOWN

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory Sullivan, MD · Tonix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2023-10-08
Completion
2023-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679908 on ClinicalTrials.gov