Effect of Sildenafil in Individuals With Migraine Pretreated With Erenumab

Migraine Without Aura Clinical Trial

— COMPETE  

Official title:

Effect of Sildenafil in Individuals With Migraine Pretreated With Erenumab: A Randomized Double-Blind Placebo-Controlled Two-Way Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889455
• Other study ID #: H-22031717
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: October 12, 2023

Study information

• Verified date: October 2023
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant has provided informed consent prior to initiation of any study-specific activities/procedures.

• Age =18 years upon entry into screening.

• History of migraine without aura for =12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.

Exclusion Criteria:

• History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of =5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.

• History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.

• Intake of prophylactic migraine medication within =30 days or 5 plasma half-lives (whichever is longer) prior to screening.

• Prior intake of therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, and small molecule CGRP receptor antagonists.

• The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.

• History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

• Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.

• Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.

• Evidence of current pregnancy or breastfeeding per participant self-report or medical records.

• Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• Sildenafil
Oral administration of 100mg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	Novartis

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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; (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).	12 hours
Secondary	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
Secondary	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