Tension-Type HeadachePhase 2NCT02423408
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
A Phase 2 study testing TNX-201 in people with Tension-Type Headache, run by Tonix Pharmaceuticals, Inc. at 10 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- TNX-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Current evidence of human immunodeficiency virus infection or clinically significant hepatitis B or C infection.
- Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history.
- 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.
- Women who are pregnant, breast-feeding, or planning to become pregnant during this trial.
- Any other household member currently participating in a Tonix-sponsored study or family member or relative of investigative staff.
- Any condition and/or medical history that would make the subject unsuitable for study participation and completion.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Michigan Head-Pain Neurological Institute
Ann Arbor, Michigan, 48104
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Avail Clinical Research LLC.
DeLand, Florida, 32720
Gary D. Berman, MD
Minneapolis, Minnesota, 55402
Stephan C. Sharp, MD
Nashville, Tennessee, 37203
Duane G. Wombolt, MD
Norfolk, Virginia, 23507
John Rubino, MD
Raleigh, North Carolina, 27609
James D. Wolfe, MD
San Jose, California, 95117
Nathan Segall, MD, CPI
Stockbridge, Georgia, 30281
PMG Research of Winston-Salem, LLC.
Winston-Salem, North Carolina, 27103
About this study
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
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).
Read the detailed 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.
- Conditions
- Tension-Type Headache
- Being tested
- TNX-201, Placebo
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-201Drug
Also called (R)-isometheptene mucate
TNX-201 capsule
PlaceboDrug
Also called TNX-201 Placebo
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| TNX-201 | Experimental | 4 X 35 mg capsules to be taken when qualifying tension-type headache occurs Receives: Drug: TNX-201 |
| Placebo | Placebo comparator | 4 X placebo capsules to be taken when qualifying tension-type headache occurs Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe.
VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain
Measured: 15, 30, 60, 90 minutes and 4 hours post-dose
Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period
Measured: 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)
The Carvalho Responder analysis refers to subjects with at least 2 categories of improvement in their VAS severity category (0-100 scale). VAS severity categories were defined as "severe" if between 52-100 inclusive, "moderate" between 31-51 inclusive, "mild" between 6-30 inclusive, and pain-free if less than 6. Therefore, a Carvalho responder was either a subject who had a VAS response classified as 'severe' at baseline and 'mild' or pain-free at the post-dose assessment time point, or a subject who had a VAS response classified as 'moderate' at baseline and pain-free at the post-dose assessment time point.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracie Ruther, M.S, Study director, 1 513 579 9911 ext 2214
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423408
- Sponsor's protocol ID
- TNX-IS-T201
- Status last verified
- Dec 2016
- First submitted
- 15 Apr 2015
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02423408
- Acronym / sponsor ID
- TNX-IS-T201
- Conditions
- Tension-Type Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNX-201 | Experimental | Drug: TNX-2014 X 35 mg capsules to be taken when qualifying tension-type headache occurs |
| Placebo | Placebo comparator | Drug: Placebo4 X placebo capsules to be taken when qualifying tension-type headache occurs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-201Also: (R)-isometheptene mucateTNX-201 capsule | Drug | TNX-201 |
| PlaceboAlso: TNX-201 PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
Number of Subjects Pain Free
Time frame: 2 hours
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
3 secondary outcomes
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)
Time frame: 15, 30, 60, 90 minutes and 4 hours post-dose
Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period
Time frame: 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)
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracie Ruther, M.S study director
1 513 579 9911 ext 2214
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNX-201 in people with Tension-Type Headache, run by Tonix Pharmaceuticals, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Pain Free (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.