Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Erenumab-aooe s.c. administered every four weeks for a total of five treatments · 1 trial · 1 indication
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments |
| Arm B | PLACEBO_COMPARATOR | Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments |
| Name | Type | Description |
|---|---|---|
| Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments | DRUG | Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments |
| Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments | DRUG | Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments |
Inclusion Criteria: Subjects eligible for inclusion in the study must meet all of the following criteria: 1. Signed the informed consent; 2. Have pain-related TMD myalgia assessed by history and clinical examination as established by the DC/TMD; 3. Age 18 years and younger than 60 years; 4. Have a...