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The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced.
The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACAP38 + Imigran | Active Comparator | Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigran infusion (0.4 mg/min) for 10 mins |
|
| PACAP38 + Isotonic Saline | Placebo Comparator | Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imigran | Drug | All patients will undergo this intervention on one of two study days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of migraine | Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine | From 0 to 12 hours after infusion |
| Effect of Sumatriptan | Severity of PACAP38-induced headache and migraine after pretreatment with sumatriptan in migraine patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") | From 0 to 12 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of flushing | Facial skin blood flow (flushing) will be measured by laser doppler flowmetry to evaluate the severity of PACAP38-induced flushing with and without sumatriptan-treatment | From 0 to 4 hours after infusion |
| Facial temperature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, MD,PhD,DMSc | Danish Headache Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DanishHC | Glostrup Municipality | DK-2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33567890 | Derived | Wienholtz NKF, Christensen CE, Zhang DG, Coskun H, Ghanizada H, Al-Karagholi MA, Hannibal J, Egeberg A, Thyssen JP, Ashina M. Early treatment with sumatriptan prevents PACAP38-induced migraine: A randomised clinical trial. Cephalalgia. 2021 May;41(6):731-748. doi: 10.1177/0333102420975395. Epub 2021 Feb 10. |
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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 |
|---|---|
| D018170 | Sumatriptan |
| D012965 | Sodium Chloride |
| D051219 | Pituitary Adenylate Cyclase-Activating Polypeptide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Isotonic Saline | Other | All patients will undergo this intervention on one of two study days |
|
| Pituitary adenylate cyclase-activating peptide-38 | Other | All patients will undergo this intervention on both study days |
|
|
PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography
| From 0 to 4 hours after infusion |
| Superficial temporal artery diameter | Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound | From 0 to 4 hours after infusion |
| Severity of headache | Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") | From 0 to 12 hours after infusion |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |