The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Syddansk Universitet (University of Southern Denmark)

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

1 Nov 2024 → 10 Jul 2025

Decision date (initial)

2024-08-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Oda og Hans Svenningsens Fond

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

The purpose of the trial is to investigate the occurrence of headache and migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura and in sildenafil-treated women with migraine without aura.

Conditions and MedDRA coding

Migraine without aura

Regulatory references

Plan to share IPD

Yes

IPD plan description

Individual participant data related to primary and secondary outcomes will be published in a scientific article.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Healthy men and women with a diagnosis of migraine without aura according to the International Classification of Headache disorders.
2. Frequency of migraine between one and six attacks within the last 8 weeks.
3. Age between 18 and 50 years.
4. Weight between 60 and 90 kg.
5. Fluency in Danish or English.
6. Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) for women during the entire period of the study.

Exclusion criteria 12

1. Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification of Headache Disorders.
2. Known allergy to any component of sildenafil "Orion".
3. Member of investigational site staff or relative of investigators.
4. Headache less than 24 hours before the start of the experiment.
5. Drinking coffee, cola or alcohol less than 12 hours before the start of the experiment.
6. Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit.
7. Assumption of analgesic medications in the 48 hours preceding the experimental days.
8. Assumption of α-blockers, ritonavir and/or drugs inhibiting the activity of the CYP3A4 enzyme.
9. Anamnestic or clinical signs of cardiovascular diseases, anatomical abnormalities of the penis, retinal disorders, sickle cell anemia, multiple myeloma and/or leukemia.
10. Anamnestic or clinical signs of mental illness, abuse or smoking.
11. Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study.
12. Pregnant and/or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Difference in the occurrence of migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura.
2. Difference in the occurrence of migraine-like attacks in sildenafil-treated men and women with migraine without aura.

Secondary endpoints 3

1. Difference in the occurrence of headache in sildenafil- and placebo-treated men with migraine without aura.
2. Difference in heart rate and mean arterial pressure (MAP) between sildenafil- and placebo-treated men with migraine without aura
3. Difference in the incidence of adverse events between sildenafil- and placebo-treated men with migraine without aura

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Syddansk Universitet (University of Southern Denmark)

Sponsor organisation

Syddansk Universitet (University of Southern Denmark)

Address

Campusvej 55

City

Odense M

Postcode

5230

Country

Denmark

Scientific contact point

Organisation

Syddansk Universitet (University of Southern Denmark)

Contact name

Lanfranco Pellesi

Public contact point

Organisation

Syddansk Universitet (University of Southern Denmark)

Contact name

Lanfranco Pellesi

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications