Table 1.
Overview of Studies Included in Exposure‐Response Assessments
| Study Number/Phase/Population | Objectives | Efficacy Endpoints and Sampling Schedules | Dose Administration |
|---|---|---|---|
| LBR‐101‐021/Phase 2b/Patients with CM | Randomized, placebo‐controlled study evaluating the efficacy and safety of sc fremanezumab in comparison to placebo for the preventative treatment of CM | Number of headache days of at least moderate severity during 28‐day monthly periods starting with the 1st dose date | 1 of 3 dose treatments administered sc once monthly for 3 months: (1) monthly dosing 225 mg with a starting dose of 675 mg, (2) monthly dosing of 900 mg, or (3) monthly dosing of placebo |
| LBR‐101‐022/Phase 2b/Patients with EM | Randomized, placebo‐controlled study evaluating the efficacy and safety of sc fremanezumab in comparison to placebo for the preventative treatment of EM | Number of migraine days during 28‐day monthly periods starting with the 1st dose date | 1 of 3 dose treatments administered sc once monthly for 3 months: (1) monthly dosing of 225 mg, (2) monthly dosing of 675 mg, or (3) monthly dosing of placebo |
| TV48125‐CNS‐0049/Phase 3/Patients with CM | Randomized, placebo‐controlled study evaluating the efficacy and safety of sc fremanezumab in comparison to placebo for the preventative treatment of CM | Number of headache days of at least moderate severity during 28‐day monthly periods starting with the 1st dose date | 1 of 3 dose treatments administered sc once monthly for 3 months: (1) monthly dosing: monthly 225 mg (with a starting dose of 675 mg), (2) quarterly dosing: a single dose of 675 mg every 3 months with placebo injections on months in which fremanezumab was not injected to maintain blinding, or (3) monthly dosing of placebo |
| TV48125‐CNS‐0050/Phase 3/Patients with EM | Randomized, placebo‐controlled study evaluating the efficacy and safety of sc fremanezumab in comparison to placebo for the preventative treatment of EM | Number of migraine days during 28‐day monthly periods starting with the 1st dose date | 1 of 3 treatments administered sc once monthly for 3 months: (1) monthly dosing of 225 mg, (2) quarterly dosing: a single dose of 675 mg every 3 months with placebo injections on months in which fremanezumab was not injected to maintain blinding, or (3) monthly dosing of placebo |
| TV48125‐CNS‐0051/Phase 3/Patients with CM or EM | Randomized roll‐over study evaluating long‐term safety, tolerability, and efficacy of sc fremanezumab for the preventive treatment of migraine | Number of headache days of at least moderate severity during 28‐day monthly periods starting with the 1st dose date for patients with CM; Number of migraine days during 28‐day monthly periods starting with the 1st dose date for patients with EM | Patients randomized to active treatment groups in the phase 3 efficacy studies (TV48125‐CNS‐30049 and TV48125‐CNS‐30050) continued to receive the same treatment; patients with CM previously randomized to placebo or “new patients” (patients not rolling over from phase 3) received 1 of 2 treatments for 12 months: monthly dosing of 225 mg (with a starting dose of 675 mg) or quarterly dosing of 675 mg; patients with EM previously randomized to placebo or “new patients” (patients not rolling over from phase 3) received 1 of 2 treatments for 12 months: monthly dosing of 225 mg or quarterly dosing of 675 mg |
CM = chronic migraine; EM = episodic migraine; sc = subcutaneous.