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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized treatment phase: Erenumab | Active Comparator | Erenumab 140 mg single subcutaneous injection at baseline |
|
| Randomized treatment phase: Placebo | Placebo Comparator | Saline placebo single subcutaneous injection at baseline |
|
| Open-label extension treatment phase: Erenumab | Other | Erenumab 140 mg monthly subcutaneous injection for six months after completion of the randomized, double-blinded, placebo-controlled study phase during the open-label extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Subcutaneous injection of 140 mg erenumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine-like attack | The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. A migraine-like attack is defined attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication). | Before (-5 min) and after administration of (+12 hours) of experimental trigger |
| Measure | Description | Time Frame |
|---|---|---|
| Headache intensity | Change in headache intensity after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no pain; 10 is the worst pain imaginable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thien P Do, MD | Contact | 004541414117 | tdoo0001@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Thien P Do, MD | Danish Headache Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Recruiting | Glostrup Municipality | 2600 | Denmark |
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Randomized, double-blinded, placebo-controlled, parallel study followed by a 6-month open-label extension.
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| Placebo | Drug | Subcutaneous injection of saline placebo. |
|
|
| Calcitonin gene-related peptide | Drug | Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes. |
|
| Cilostazol | Drug | Oral intake of 200 mg cilostazol. |
|
| Before (-5 min) and after administration of (+12 hours) of experimental trigger |
| Hemodynamics (superficial temporal artery) | Change in diameter (mm) of superficial temporal artery after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. | Before (-5 min) and after administration of (+90 minutes) of experimental trigger |
| Hemodynamics (radial artery) | Change in diameter (mm) of radial artery after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. | Before (-5 min) and after administration of (+90 minutes) of experimental trigger |
| Neuropeptide plasma concentrations (CGRP) |
| (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase |
| Neuropeptide plasma concentrations (VIP) |
| (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase |
| Neuropeptide plasma concentrations (PACAP) |
| (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase |
| Facial flushing | Change in facial skin flushing after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. | Before (-5 min) and after administration of (+90 minutes) of experimental trigger |
| Facial temperature | Change in facial temperature after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. | Before (-5 min) and after administration of (+90 minutes) of experimental trigger |
| Headache day | Change in number of headache days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase. | Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase |
| Migraine day | Change in number of migraine days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase. | Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase |
| ≥50% responder rate | Proportion of participants with a ≥50% reduction in number of migraine days per month after administration of erenumab from baseline compared to the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase. | Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020326 | Migraine without Aura |
| D020325 | Migraine with Aura |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
| D015740 | Calcitonin Gene-Related Peptide |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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