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

Tension-Type Headache Clinical Trial

Official title:

A Proof-of-Concept Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-201 for the Treatment of A Single Tension-Type Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423408
• Other study ID #: TNX-IS-T201
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2015
• Last updated: February 26, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

The study will be conducted in 4 periods (the Screening Period, the Run-In Period, the Double-Blind Treatment Period and the Follow-up Period) and 4 visits (the Screening Visit, Enrollment Visit, Randomization Visit and End-of-Study Visit).

Screening Period- Eligible subjects who provide written informed consent to participate will have study assessments performed at the Screening.

Run-In Period- The Run-In Period will last for at least 28 days. During the Run-In period, subjects will be assessed for frequency of headache, study compliance and to ensure they meet all required study criteria for randomization.

Double-Blind Treatment Period- The Double-Blind Treatment Period (Treatment Period) will last up to 4 weeks or until a qualifying headache episode has occurred and been treated using the study drug, whichever occurs first.

Follow-up Period- All subjects will return to the investigational site for this visit, regardless of whether they have treated a qualifying TTH with study medication. Subjects who have not treated a qualifying TTH with study drug during the Treatment Period will be asked to return study materials and undergo safety evaluations at the End-of-Study Visit and will be discharged from the study. Subjects who have treated a qualifying TTH with study drug during the Treatment Period will ingest a 140 mg dose of open-label TNX-201 at this visit and undergo urine and blood sample collection for 3 hours post-dose to characterize each subject's genetic metabolism and PK profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 = 40.0.

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.

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 one attack per month during the preceding calendar year.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Drug:
• TNX-201
TNX-201 capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Avail Clinical Research LLC.	DeLand	Florida
United States	Gary D. Berman, MD	Minneapolis	Minnesota
United States	Stephan C. Sharp, MD	Nashville	Tennessee
United States	Duane G. Wombolt, MD	Norfolk	Virginia
United States	John Rubino, MD	Raleigh	North Carolina
United States	James D. Wolfe, MD	San Jose	California
United States	Nathan Segall, MD, CPI	Stockbridge	Georgia
United States	PMG Research of Winston-Salem, LLC.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects pain free	Proportion of subjects pain free at 2 hours and from 2 to 24 hours post-dose (Pain will be assessed by 4-point NRS, VAS, and binary yes/no question)	up to 24 hours	No
Secondary	Proportion 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	No
Secondary	Proportion of subjects using rescue medication during the 24-hour post-dose period		24-hour post-dose period	No
Secondary	Change from baseline in pain severity score at 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, and 4 hours post-dose		5 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, and 4 hours post-dose	No