Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Intervention: TNX-201; Placebo
Intervention description: TNX-201 capsule; Placebo capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to
      evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a
      single qualifying Tension-Type-Headache (TTH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Capable of reading and understanding English and able to provide written informed
             consent to participate.

          2. Male or female adults ≥ 18 and < 65 years of age at the time of Visit 1.

          3. Body mass index (BMI) ≥ 18.5 and ≤ 45.0.

          4. Greater than 1 year history of episodic tension-type headache with onset prior to 50
             years of age.

          5. History of tension-type headaches that typically last ≥ 4 hours if untreated.

          6. History of 2-14 tension-type headaches per month for the last 3 months prior to Visit
             1.

          7. Diagnosis must comply with the International Headache Society (IHS) diagnostic
             criteria.

          8. No significant ECG findings at Screening

          9. If female, is either not of childbearing potential or is practicing a predefined
             medically acceptable method of birth control (hormonal methods, intrauterine device,
             double-barrier method, sexually-exclusive vasectomized male partner, same-sex
             relationship) throughout the study.

         10. Willing and able to comply with all protocol-specified requirements.

        Exclusion Criteria:

          1. Known or suspected hypersensitivity to isometheptene mucate or any excipients used in
             the formulation.

          2. Use of any excluded concomitant medications.

          3. Current use of opiate analgesics.

          4. Use of any prophylactic drug therapy for headache control within 4 weeks of screening
             (e.g., anticonvulsants, mood stabilizers, beta-blocker, antidepressants, muscle
             relaxants, botulinum toxin). Subjects taking any of these medications for an
             indication other than headache (e.g., a beta-blocker for hypertension) will require
             medical monitor's approval prior to initiation of the Run-In Period.

          5. History of medication use for acute headache on ≥ 10 days per month on average during
             the 3 months prior to Visit 1.

          6. Positive results for addictive substances (e.g., cocaine, phencyclidine (PCP),
             amphetamines, opiates) at Screening.

          7. History of migraine that exceeds a mean of four attacks per month during the preceding
             calendar year.

          8. Lifetime history of schizophrenia, schizoaffective disorder, bipolar I/II disorder,
             delusional disorder, or psychotic disorder not otherwise specified.

          9. Chronic pain disorders requiring medical treatment with opioids, chronic daily use of
             NSAIDs at the time of screening

         10. History of coronary artery disease, coronary vasospasm, aortic aneurysm, peripheral
             vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or
             Raynaud's syndrome).

         11. Inadequately controlled hypertension or persistently elevated systolic blood pressure
             or diastolic blood pressure upon repeat assessment at screening or on the day of
             randomization.

         12. Current history of two or more CAD risk factors at Screening (tobacco use, receiving
             anti-hypertensive medication for hypertension, high LDL cholesterol or low HDL
             cholesterol levels, family history of premature CAD, diabetes mellitus)

         13. History cerebral vascular accident, transient ischemic attack, seizure disorders.

         14. Other clinically significant cardiac disease.

         15. History of concurrent illness that requires hospitalization within 30 days prior to
             Visit 1.

         16. Current evidence of human immunodeficiency virus infection or clinically significant
             hepatitis B or C infection.

         17. Clinically significant laboratory abnormalities based on screening laboratory tests
             and/or medical history.

         18. Participation in another investigational trial during the 30 days prior to Visit 1 or
             during this trial. Subjects who have participated in non-interventional trials may be
             permitted to participate on a case-by-case basis after review with the Medical
             Monitor.

         19. Women who are pregnant, breast-feeding, or planning to become pregnant during this
             trial.

         20. Any other household member currently participating in a Tonix-sponsored study or
             family member or relative of investigative staff.

         21. Any condition and/or medical history that would make the subject unsuitable for study
             participation and completion.