Trial · NCT02423408
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
NCT02423408, Phase 2, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2017-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache. Trials, record NCT02423408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02423408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
- NCT number
- NCT02423408
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- Tension-Type Headache
- Interventions
- TNX-201, Placebo
- First posted
- 2015-04-22
- Last updated
- 2017-04-11
- Results first posted
- 2017-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Pain Free | 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 |
| Secondary | 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 | 4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe. VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain |
| Secondary | Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period | 24-hour post-dose period | |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Pain Free | 2 hours | LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period | 24-hour post-dose period | 8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Only subjects who were categorized as severe or moderate at baseline and have data reported at 2 hours were included in this analysis. All subjects who took rescue medication at or before 2 hours were considered non-responders. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Pain Free | TNX-201 | Binary Response | 21 | Participants | |
| Number of Subjects Pain Free | Placebo | Binary Response | 20 | Participants | |
| Number of Subjects Pain Free | TNX-201 | 4-Point NRS | 21 | Participants | |
| Number of Subjects Pain Free | Placebo | 4-Point NRS | 19 | Participants | |
| Number of Subjects Pain Free | TNX-201 | VAS | 20 | Participants | |
| Number of Subjects Pain Free | Placebo | VAS | 21 | Participants | |
| 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) | TNX-201 | Binary Response : 15 Minutes | 1 | Participants | |
| 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) | Placebo | Binary Response : 15 Minutes | 0 | Participants | |
| 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) | TNX-201 | Binary Response : 30 Minutes | 4 | Participants | |
| 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) | Placebo | Binary Response : 30 Minutes | 2 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TNX-201 | 83 | |
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | COMPLETED | TNX-201 | 82 | |
| Overall Study | COMPLETED | Placebo | 80 | |
| Overall Study | NOT COMPLETED | TNX-201 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | TNX-201 | 1 | 78 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 73 | |
| other | Abdominal discomfort | Gastrointestinal disorders | TNX-201 | 1 | 78 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 73 | |
| other | Chills | General disorders | TNX-201 | 1 | 78 | |
| other | Chills | General disorders | Placebo | 0 | 73 | |
| other | Dry Mouth | Gastrointestinal disorders | TNX-201 | 1 | 78 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 0 | 73 | |
| other | Malaise | General disorders | TNX-201 | 1 | 78 | |
| other | Malaise | General disorders | Placebo | 0 | 73 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNX-201 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | TNX-201 | 5 | 78 |
| Total, other adverse events | Placebo | 6 | 73 |
| Total, serious adverse events | TNX-201 | 0 | 78 |
| Total, serious adverse events | Placebo | 0 | 73 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TNX-201 vs Placebo: Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period | Trial comparisons |
| TNX-201 vs Placebo: Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders) | Trial comparisons |
| TNX-201 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02423408
GET https://conductscience.org/api/trials/v1/NCT02423408/results?page=2