Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache

NCT02423408 | Completed Phase 2 Results

• 1 other identifier: TNX-IS-T201
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Pain Free

  Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question). 4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; "pain-free" defined as score = 0. VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). "Pain-free" was defined as a score \<= 5

  2 hours

Secondary Outcomes (3)

• Number of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question)

  15, 30, 60, 90 minutes and 4 hours post-dose

• Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period

  24-hour post-dose period

• Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)

  2 hours

Study Arms (2)

TNX-201

EXPERIMENTAL

4 X 35 mg capsules to be taken when qualifying tension-type headache occurs

Drug: TNX-201

Placebo

PLACEBO COMPARATOR

4 X placebo capsules to be taken when qualifying tension-type headache occurs

Drug: Placebo

Interventions

TNX-201 DRUG

TNX-201 capsule

Also known as: (R)-isometheptene mucate

TNX-201

Placebo DRUG

Placebo capsule

Also known as: TNX-201 Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of reading and understanding English and able to provide written informed consent to participate.
• Male or female adults ≥ 18 and \< 65 years of age at the time of Visit 1.
• Body mass index (BMI) ≥ 18.5 and ≤ 45.0.
• Greater than 1 year history of episodic tension-type headache with onset prior to 50 years of age.
• History of tension-type headaches that typically last ≥ 4 hours if untreated.
• History of 2-14 tension-type headaches per month for the last 3 months prior to Visit 1.
• Diagnosis must comply with the International Headache Society (IHS) diagnostic criteria.
• No significant ECG findings at Screening
• 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.
• Willing and able to comply with all protocol-specified requirements.

You may not qualify if:

• Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulation.
• Use of any excluded concomitant medications.
• Current use of opiate analgesics.
• 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.
• History of medication use for acute headache on ≥ 10 days per month on average during the 3 months prior to Visit 1.
• Positive results for addictive substances (e.g., cocaine, phencyclidine (PCP), amphetamines, opiates) at Screening.
• History of migraine that exceeds a mean of four attacks per month during the preceding calendar year.
• Lifetime history of schizophrenia, schizoaffective disorder, bipolar I/II disorder, delusional disorder, or psychotic disorder not otherwise specified.
• Chronic pain disorders requiring medical treatment with opioids, chronic daily use of NSAIDs at the time of screening
• 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).
• Inadequately controlled hypertension or persistently elevated systolic blood pressure or diastolic blood pressure upon repeat assessment at screening or on the day of randomization.
• 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)
• History cerebral vascular accident, transient ischemic attack, seizure disorders.
• Other clinically significant cardiac disease.
• History of concurrent illness that requires hospitalization within 30 days prior to Visit 1.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (10)

James D. Wolfe, MD

San Jose, California, 95117, United States

Location

Avail Clinical Research LLC.

DeLand, Florida, 32720, United States

Location

Nathan Segall, MD, CPI

Stockbridge, Georgia, 30281, United States

Location

Michigan Head-Pain Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Gary D. Berman, MD

Minneapolis, Minnesota, 55402, United States

Location

John Rubino, MD

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Winston-Salem, LLC.

Winston-Salem, North Carolina, 27103, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Stephan C. Sharp, MD

Nashville, Tennessee, 37203, United States

Location

Duane G. Wombolt, MD

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Judith Gendreau, Senior Medical Director
• Organization: Tonix Pharmaceuticals

judy.gendreau@tonixpharma.com

858-433-5574

Study Officials

• Tracie Ruther, M.S

  1 513 579 9911 ext 2214

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 11, 2017
• Results First Posted: February 17, 2017

Record last verified: 2016-12

Locations

US (10)