Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Erenumab Dose 1
Erenumab · 5 trials · 4 indications
Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol. The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.
Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.
At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week treatment phase - the number of migraine days during the 4-week baseline phase.
The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
The severity of hot flashes was assessed by participants based on the following categories: * Mild: sensation of heat without sweating, mild flushing; * Moderate: sensation of heat, face flushed, slightly clammy, some sweating, able to continue activity, may want to remove layers of clothing or covers at night; * Severe: sensation of heat with more severe sweating, have to stop current activity, may have to change clothing. Baseline (BL) number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day -7 to day 1 predose based on geometric mean, and the week 4 number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day 21 to day 27 based on geometric mean. The ratio of week 4 to BL was used to assess change from BL to week 4 via a log transformation (log\[week4/BL\] = log\[week4\] - log\[BL\]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received a single dose of placebo administered by intravenous infusion on day 1. |
| Erenumab | EXPERIMENTAL | Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1. |
| Erenumab 70 mg | EXPERIMENTAL | Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. |
| Erenumab 140 mg | PLACEBO_COMPARATOR | Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. |
| Erenumab + Estrogen/Progestin Contraceptive | EXPERIMENTAL | Participants received a combination oral contraceptive for 3 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider. |
| Name | Type | Description |
|---|---|---|
| Erenumab | DRUG | A single dose of erenumab 140 mg infused over approximately 60 minutes. |
| Placebo | DRUG | A single dose of a matching volume of placebo infused over approximately 60 minutes. |
| Ethynil Estradiol/Norgestimate Oral Contraceptive | DRUG | Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle. |
Inclusion Criteria * History of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month * Ischemic heart disease documented by myocardial infarction, coronary angiography or a revascularization procedure * Receiving stable doses of cardiac medication ...
Erenumab is an investigational drug being studied for the treatment and prevention of chronic migraine, as well as for headache, vasomotor symptoms such as hot flashes, and stable angina. It is in clinical development for these conditions, with trials conducted in migraine patients and other populations.
Erenumab is a monoclonal antibody, indicated by its -mab suffix, and is being developed as a small molecule therapy. Its specific molecular target has not been disclosed in available clinical trial information, so its exact mechanism of action is not described here.
Erenumab is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Erenumab is in Phase 1 clinical development, with early-stage trials completed in healthy adults and migraine patients. A Phase 3 trial in pediatric participants with episodic migraine is also active but not recruiting, indicating ongoing investigation across different stages.
Erenumab has been studied in several clinical trials, including NCT01688739 and NCT01723514, which evaluated ascending single and multiple doses in healthy adults and migraine patients. NCT01890109 studied the drug in women with hot flashes, and NCT03836040 is a Phase 3 trial in pediatric migraine patients.
Yes, Erenumab is also known as Erenumab Dose 1. This alternative name appears in clinical trial contexts, and both names refer to the same investigational drug being developed by Amgen for migraine and other conditions.