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Not yet recruiting NCT06632080

Effects of Substance P on Headache Induction in Healthy Individuals

No phase Interventional Healthy Volunteers Only

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Substance P, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers Only. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Substance P on Headache Induction in Healthy Individuals: a Randomized Clinical Trial

Overview

Substance P is a signaling molecule that has been implicated in the pathogenesis of headache. This study aims to ascertain whether administration of substance P can induce headache in healthy adults.

Detailed description

Substance P is a vasoactive signaling molecule that belongs to the tachykinin family of peptides. It is expressed in multiple cells, including primary afferents of the trigeminal ganglion that innervate the meninges and its arteries. The best-known function of substance P is its role in pain transmission, and several lines of evidence has implicated substance P in the pathogenesis of headache. This study aims to ascertain whether intravenous infusion of substance P induces headache in healthy individuals who have no past or current history of primary or secondary headache disorder, except for infrequent episodic tension-type headache. For this purpose, we will conduct a randomized, double-blind, placebo-controlled, 2-way crossover trial.

Interventions

  • Drug Substance P
    The participants will receive a continuous intravenous infusion of 20 mL of substance P (1.5 pmol/kg/min) over 20 minutes.
  • Drug Placebo
    The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Primary outcome measures

  • Incidence of Headache [Time frame: 12 hours]
Secondary outcome measures (1)
  • Headache Intensity Scores [Time frame: 12 hours]

Eligibility criteria

Inclusion criteria

  • Age 18 to 65 years of age upon entry into screening
  • A body weight of 50 to 100 kg
  • Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion criteria

  • Any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache
  • Any first-degree relatives with a history of a primary headache disorder, except for 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
  • Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
  • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
  • Female subjects of childbearing potential with a positive pregnancy test during any study visit
  • Cardiovascular disease of any kind, including cerebrovascular diseases
  • Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
  • Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
  • Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
  • Daily use of any medication other than contraceptives
  • Intake of any medication other than contraceptives within 48 hours of infusion start
  • Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start
  • Headache of any intensity within 48 hours of infusion start

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Danish Headache Center, Copenhagen University Hospital - Rigshospitalet — Glostrup Municipality

Publications

  • Al-Khazali HM, Christensen RH, Gozalov E, Hakimzadeh Z, Melchior AG, Dominguez-Moreno R, Ashina M, Ashina H. Effects of substance P on headache induction and arterial dilation in healthy adults. Cephalalgia. 2025 May;45(5):3331024251336132. doi: 10.1177/03331024251336132. Epub 2025 May 14. PMID 40369974

Identifiers

NCT: NCT06632080 · H-23030963

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗