MigraineNCT06959004
Substance P-Induced Migraine Attacks Without Aura
A study testing Substance P in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- 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
- 13 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- 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
- 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
Who cannot join
- 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
- 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
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- 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)
- Daily use of any medication other than contraceptives
- Intake of any medication other than contraceptives within 48 hours of infusion start
- Headache of any intensity within 48 hours of infusion start
- Migraine attack within 5 days of infusion start
- Aura within 48 hours of infusion start
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Haidar Al-Khazali, MD, 41598494, haidardk@hotmail.com
Hakan Ashina, MD, PhD, +4528102495, haakan.ashina@regionh.dk
About this study
Official title: Substance P-Induced Migraine Attacks Without Aura: A Randomized Clinical 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.
Read the detailed description
Substance P is a vasoactive neuropeptide of the tachykinin family, expressed in various cell types, including primary afferents of the trigeminal ganglion that innervate the meninges and associated vasculature. Its most well-established role is in nociceptive signaling, and accumulating evidence implicates substance P in the pathogenesis of headache. This study investigates whether intravenous infusion of substance P can induce migraine attacks in individuals with a history of migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.
- Conditions
- Migraine
- Being tested
- Substance P, Placebo
- Keywords
- Headache, Migraine, Pain, Substance P
- Medical subject headings
- Migraine Disorders, Headache, Pain
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 (4.0 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 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.
Measured: 12 hours
Secondary outcomes (1)
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.
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 posted6 May 2025
- Study start13 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.
- 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, Haidar Al-Khazali, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959004
- Sponsor's protocol ID
- H-23034165
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 5 Jun 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance P-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06959004
- Acronym / sponsor ID
- H-23034165
- Conditions
- Migraine
- Keywords
- Headache, Migraine, Pain, Substance P
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 May 2025 (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 neuropeptide implicated in the pathogenesis of headache. This study investigates whether its administration can trigger migraine attacks in individuals with migraine without aura.
Detailed description
Substance P is a vasoactive neuropeptide of the tachykinin family, expressed in various cell types, including primary afferents of the trigeminal ganglion that innervate the meninges and associated vasculature. Its most well-established role is in nociceptive signaling, and accumulating evidence implicates substance P in the pathogenesis of headache. This study investigates whether intravenous infusion of substance P can induce migraine attacks in individuals with a history of migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-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
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.
| 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
- 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
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 (4.0 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 migraine attacks without aura
Time frame: 12 hours
The difference in the incidence of migraine attacks without aura between substance P and placebo during the 12-hour observational period after infusion start.
1 secondary outcome
Headache intensity scores
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- 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.
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 Migraine, 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haidar Al-Khazali, MD (+4541598494, haidardk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of migraine attacks without aura (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.