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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:June 2015
End Date:February 2016

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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

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).

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.

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.
We found this trial at
9
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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Cleveland, Ohio 44122
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Minneapolis, Minnesota 55402
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Nashville, Tennessee 37203
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Norfolk, Virginia 23507
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Raleigh, North Carolina 27609
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San Jose, California 95117
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Stockbridge, Georgia 30281
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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