Healthy Volunteers OnlyNCT06632080
Effects of Substance P on Headache Induction in Healthy Individuals
A study testing Substance P in people with Healthy Volunteers Only, run by Danish Headache Center at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- Substance P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Copenhagen University Hospital - Rigshospitalet
Glostrup Municipality, 2600
Hakan Ashina, MD, PhD, +45 28 10 24 95, haakan.ashina@regionh.dk
About this study
Official title: Effects of Substance P on Headache Induction in Healthy Individuals: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Healthy Volunteers Only
- Being tested
- Substance P, Placebo
- Keywords
- Headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance PDrug
The participants will receive a continuous intravenous infusion of 20 mL of substance P (1.5 pmol/kg/min) over 20 minutes.
PlaceboDrug
The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Substance P | Experimental | Substance P will be administered by intravenous infusion. Receives: Drug: Substance P |
| Placebo | Placebo comparator | Placebo (isotonic saline) will be administered by intravenous infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Headache
The primary outcome is the difference in the incidence of headache* between substance P and placebo during the 12-hour observational period after infusion start.
- The intensity of headache is rated by the subject on the 11-point numerical rating scale (0 being no headache, 10 being the worst imaginable headache).
Measured: 12 hours
Secondary outcomes (1)
Headache Intensity Scores
The secondary outcome is the difference in the area under the curve for median headache intensity scores between substance P and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start14 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The present trial has a randomized, double-blind, placebo-controlled, 2-way crossover design and will be conducted at a single site.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkan Ashina, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632080
- Sponsor's protocol ID
- H-23030963
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
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.
PubMed 40369974
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Substance P on Headache Induction in Healthy Individuals: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06632080
- Acronym / sponsor ID
- H-23030963
- Conditions
- Healthy Volunteers Only
- Keywords
- Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 14 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present trial has a randomized, double-blind, placebo-controlled, 2-way crossover design and will be conducted at a single site.
| Arm | Type | Receives |
|---|---|---|
| Substance P | Experimental | Drug: Substance PSubstance P will be administered by intravenous infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (isotonic saline) will be administered by intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance PThe participants will receive a continuous intravenous infusion of 20 mL of substance P (1.5 pmol/kg/min) over 20 minutes. | Drug | Substance P |
| PlaceboThe participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes. | Drug | Placebo |
Primary outcome
Incidence of Headache
Time frame: 12 hours
The primary outcome is the difference in the incidence of headache* between substance P and placebo during the 12-hour observational period after infusion start. * The intensity of headache is rated by the subject on the 11-point numerical rating scale (0 being no headache, 10 being the worst imaginable headache).
1 secondary outcome
Headache Intensity Scores
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40369974Al-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.
- Individual participant dataSharing planned: Yes. Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substance P in people with Healthy Volunteers Only, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Ashina, MD, PhD (+45 28 10 24 95, haakan.ashina@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Headache (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.