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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02741310 | Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan | PHASE1 | COMPLETED | 34 | — | — | Feb 22, 2016 | Aug 11, 2016 | Apr 2, 2019 | 1 | Belgium |
Mean arterial pressure (MAP) is the average arterial pressure during a single cardiac cycle. MAP was calculated as diastolic blood pressure (DBP) + 0.33 \* (systolic blood pressure \[SBP\]-DBP). Individual time-weighted average in MAP were calculated as area under the measurement-time curve from predose through 2.5 hours of MAP divided by the time period over which the measurements were made (ie, AUCmap0-2.5 hr /2.5 hours). Data were analyzed using a linear mixed effects regression model with fixed effects for treatment and period and random effect for subject; Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2). |
| Erenumab | EXPERIMENTAL | Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered by intravenous infusion |
| Sumatriptan | DRUG | Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5 |
| Erenumab | DRUG | Administered by intravenous infusion |
Inclusion Criteria: * Healthy male and female subjects ≥ 18 to ≤ 55 years old * Good general health * Laboratory results within range * Other Inclusion Criteria May Apply Exclusion Criteria: * Female subjects pregnant or breastfeeding * An unstable medical condition * History of cancer * Active l...