Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02423408 | Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache | PHASE2 | COMPLETED | 165 | — | — | Jun 1, 2015 | Feb 1, 2016 | Apr 11, 2017 | 10 | United States |
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
| Arm | Type | Description |
|---|---|---|
| TNX-201 | EXPERIMENTAL | 4 X 35 mg capsules to be taken when qualifying tension-type headache occurs |
| Placebo | PLACEBO_COMPARATOR | 4 X placebo capsules to be taken when qualifying tension-type headache occurs |
| Name | Type | Description |
|---|---|---|
| TNX-201 | DRUG | TNX-201 capsule |
| Placebo | DRUG | Placebo capsule |
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 ≤ 45.0. 4. Greater than 1 year history of episodic tensio...