Substance P-Induced Migraine Attacks Without Aura

ConditionMigraine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorDanish Headache Center

About this trial

Substance P is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether its administration can trigger migraine attacks in individuals with migraine without aura.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 65 years of age upon entry into screening

A body weight of 50 to 100 kg

History of migraine without aura for ≥12 months and in accordance with ICHD-3

Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening

Disqualifiers

Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache

Any history of moderate to severe traumatic brain injury

Any history of cardiovascular disease, including cerebrovascular diseases

Any history of pulmonary disease

Trial design

Design model

Crossover

Treatments tested in this trial

Substance P
Drug
The participants will receive a continuous intravenous infusion of 20 mL of substance P (4.0 pmol/kg/min) over 20 minutes.
Placebo
Drug
The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Treatment groups

21 Participants

are divided into 2 treatment groups

Group A: Substance PExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of migraine attacks without aura

The difference in the incidence of migraine attacks without aura between substance P and placebo during the 12-hour observational period after infusion start.

Time frame

12 hours

Secondary outcomes

Headache intensity scores

The secondary outcome is the difference in the area under the curve (AUC) for headache intensity scores between substance P and placebo during the 12-hour observational period after infusion start.

Time frame

12 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov

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