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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intake of sildenafil (a potent vasodilator) can induce cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Oral administration of 100mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of migraine attack | Difference in incidence of migraine attack (0 to 12 hours) between sildenafil and placebo. A migraine attack is defined as an 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:
D. During headache at least one of the following:
(ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of headache | Difference in incidence of headache (0 to 12 hours) between sildenafil and placebo. Incidence of headache is defined as headache intensity ≥1 as measured by a numerical rating scale (NRS) from 0 to 10. It is a verbally declared scale from 0 to 10, where 0 is no pain; 10 is the worst pain imaginable. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38850034 | Derived | Raffaelli B, Do TP, Ashina H, Snellman J, Maio-Twofoot T, Ashina M. Induction of cGMP-mediated migraine attacks is independent of CGRP receptor activation. Cephalalgia. 2024 Jun;44(6):3331024241259489. doi: 10.1177/03331024241259489. |
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| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Other |
Placebo |
|
| Intensity of headache |
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between sildenafil and 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. |
| 12 hours |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |