Phase 2
Completed N=88
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
Migraine · Chronic Migraine, Headache · Chronic Migraine Without Aura · Aura Migraine
Source: ClinicalTrials.gov NCT05679908 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Mean Change in the Number of Monthly Migraine Headache Days — -8.17; -7.78; -5.77 number of days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Number of Monthly Migraine Headache Days |
-8.17; -7.78; -5.77 | — |
| SECONDARY Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days |
15; 15; 10 | — |
| SECONDARY Mean Change in the Number of Days Using Rescue Medication |
-3.16; -4.09; -2.07 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
12; 16; 14 | — |
| SECONDARY Mean Change in the Number of Moderate or Severe Headache Days |
-8.39; -8.17; -5.00 | — |
| SECONDARY Mean Change in the Number of Migraine Headache Days |
-7.09; -6.67; -5.24 | — |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire |
26.07; 28.98; 21.10 | — |
Eligibility Criteria
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 3 months prior to Visit 1 as defined by IHS ICHD-3
- Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for 90 days prior to Screening and during the study. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Note: Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study.
Major Exclusion Criteria:
- History of cluster headache.
- Presence of headaches more than 26 days a month on average for the 6 months prior to Screening.
- Failed to benefit from an adequate dose and duration, in the investigator's judgment (eg, one month of β-blocker), of 3 or more migraine preventive medications.
- Use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to Visit 1 and during the study.
- Use of over-the-counter (OTC) nasal products (ie, saline spray, Neti-Pot, Naväge® etc.) during the study.
- Any use of intranasal corticosteroid medications or conditions in which use of intranasal corticosteroids may be indicated during the study, eg, unstable allergic rhinitis that has previously required intranasal corticosteroids. Intranasal corticosteroid use is not allowed within 28 days of Baseline/Randomization/Visit 2 and during the treatment phase or follow-up period of the study.
- Patients who recently discontinued treatment with an anti-calcitonin-gene-related peptide (CGRP) or participated in anti-CGRP clinical study must be at least 4 months from the last drug administration prior to Visit 1.
Data sourced from ClinicalTrials.gov (NCT05679908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.