Ischemic StrokePhase 2Cap-SPGASNCT07406971
Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke
A Phase 2 study testing Capsaicin Transmucosal Oral Film in people with Ischemic Stroke, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
This study will evaluate the safety and tolerability of a dissolvable oral film containing a very small dose of capsaicin (the compound that produces the "hot" sensation in chili peppers) in adults with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Capsaicin Transmucosal Oral Film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2025to 31 Oct 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 at screening.
- Symptom onset within 24 hours prior to study intervention.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
- Provision of written informed consent by the participant or legally authorized representative.
Who cannot join
- Intracranial hemorrhage on neuroimaging.
- Severe impairment of consciousness judged by the investigator to preclude safe participation.
- Persistent blood pressure >220/120 mmHg after initial medical management.
- Severe systemic disease that, in the investigator's judgment, may interfere with study participation or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, 20000
Jorge O López, MD, 449 994 6720, neurogeorge@gmail.com
About this study
Official title: Safety of Transmucosal Capsaicin for Chemical Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke Within 24 Hours of Symptom Onset: A Randomized Double-Blind Placebo-Controlled Trial
This study will evaluate the safety and tolerability of a dissolvable oral film containing a very small dose of capsaicin (the compound that produces the "hot" sensation in chili peppers) in adults with acute ischemic stroke. The film is designed to stimulate nerves in the mouth that may activate the sphenopalatine ganglion, a structure involved in regulating blood flow to the brain. The main purpose of this study is to determine whether the capsaicin film can be given safely to patients with acute ischemic stroke when started within 24 hours of symptom onset.
Participants will be randomly assigned (like flipping a coin) to receive either the capsaicin oral film or a placebo film that looks and tastes similar but contains no capsaicin. Neither the participants nor the clinical team will know which film is given (double-blind). All participants will continue to receive standard medical care for acute ischemic stroke.
Read more
After administration of the study film, participants will be closely monitored for side effects and changes in vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) at prespecified time points up to 72 hours. The primary outcome is the frequency of adverse events related to the study product within 72 hours after treatment begins. Participants will also be followed clinically up to 3 months as part of usual stroke care.
The results of this study will help determine whether this approach is safe and feasible, and whether further studies are warranted.
- Conditions
- Ischemic Stroke
- Being tested
- Capsaicin Transmucosal Oral Film, Placebo Transmucosal Oral Film
- Keywords
- Acute ischemic stroke, Capsaicin, Sphenopalatine ganglion stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Transmucosal Oral FilmDrug
A dissolvable transmucosal oral film containing a low dose of capsaicin designed for local administration in the oral cavity. The formulation is intended to provide controlled mucosal exposure to capsaicin for investigational neuromodulatory stimulation of trigeminal-parasympathetic pathways potentially involved in cerebral blood flow regulation. The film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke.
Placebo Transmucosal Oral FilmDrug
A dissolvable transmucosal oral film identical in appearance, texture, and administration method to the active study film but without capsaicin. The placebo film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Transmucosal Capsaicin | Experimental | Not described Receives: Drug: Capsaicin Transmucosal Oral Film |
| Placebo Oral Film | Placebo comparator | Not described Receives: Drug: Placebo Transmucosal Oral Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events Within 72 Hours After Administration
The primary outcome is the proportion of participants experiencing any adverse event within 72 hours after administration of the study oral film. Adverse events include any unfavorable clinical sign, symptom, or change in vital signs temporally associated with study treatment, regardless of causality. Vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) are recorded at predefined time points during the first 72 hours.
Measured: 72 hours after study intervention administration
Secondary outcomes (3)
Change in Systolic Blood Pressure Over 72 Hours
Change in systolic blood pressure (mmHg) from baseline (pre-dose) to each prespecified post-dose assessment time point through 72 hours. Values will be summarized by treatment group.
Measured: Baseline (pre-dose) through 72 hours post-dose
Change in Heart Rate Over 72 Hours
Change in heart rate (beats per minute) from baseline (pre-dose) to each prespecified post-dose assessment time point through 72 hours. Values will be summarized by treatment group.
Measured: Baseline (pre-dose) through 72 hours post-dose
Treatment Tolerability Within 72 Hours
Proportion of participants who complete the assigned study oral film administration without discontinuation due to intolerance, and incidence of local tolerability symptoms (e.g., oral burning/irritation, excessive salivation, cough) within 72 hours after administration.
Measured: Up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Responsible party
- Principal investigator, Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406971
- Sponsor's protocol ID
- Cap-SPGAS
- Acronym
- Cap-SPGAS
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, subject to institutional approval, data use agreements, and applicable privacy regulations.
Publications
Marquez-Romero JM, Huerta-Franco MR, Vargas-Luna M, Madrigal-Gutierrez CA, Esparza-Hernandez JM, Velazquez-Barcena MG. Dose Escalation and Safety of Capsaicin for Cerebral Perfusion Augmentation: A Pilot Study. Stroke. 2021 Jul;52(7):2203-2209. doi: 10.1161/STROKEAHA.120.032773. Epub 2021 May 10.
PubMed 33966493Marquez-Romero JM, Garcia-Perales C, Garcia-Arellano M, Ortiz MS, Perez-Malagon CD, Huerta-Franco MR, Vargas-Luna FM. Capsaicin for Cerebral Perfusion Augmentation: A Randomized Open-Label Trial. Stroke. 2024 Apr;55(4):e112-e114. doi: 10.1161/STROKEAHA.123.046045. Epub 2024 Mar 8. No abstract available.
PubMed 38456262
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Transmucosal Capsaicin for Chemical Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke Within 24 Hours of Symptom Onset: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07406971
- Acronym / sponsor ID
- Cap-SPGAS / Cap-SPGAS
- Conditions
- Ischemic Stroke
- Keywords
- Acute ischemic stroke, Capsaicin, Sphenopalatine ganglion stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 12 Feb 2026 (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.
This study will evaluate the safety and tolerability of a dissolvable oral film containing a very small dose of capsaicin (the compound that produces the "hot" sensation in chili peppers) in adults with acute ischemic stroke. The film is designed to stimulate nerves in the mouth that may activate the sphenopalatine ganglion, a structure involved in regulating blood flow to the brain. The main purpose of this study is to determine whether the capsaicin film can be given safely to patients with acute ischemic stroke when started within 24 hours of symptom onset.
Participants will be randomly assigned (like flipping a coin) to receive either the capsaicin oral film or a placebo film that looks and tastes similar but contains no capsaicin. Neither the participants nor the clinical team will know which film is given (double-blind). All participants will continue to receive standard medical care for acute ischemic stroke.
After administration of the study film, participants will be closely monitored for side effects and changes in vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) at prespecified time points up to 72 hours. The primary outcome is the frequency of adverse events related to the study product within 72 hours after treatment begins. Participants will also be followed clinically up to 3 months as part of usual stroke care.
The results of this study will help determine whether this approach is safe and feasible, and whether further studies are warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmucosal Capsaicin | Experimental | Drug: Capsaicin Transmucosal Oral Film |
| Placebo Oral Film | Placebo comparator | Drug: Placebo Transmucosal Oral Film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years.
- National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 at screening.
- Symptom onset within 24 hours prior to study intervention.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
- Provision of written informed consent by the participant or legally authorized representative.
Key exclusion criteria (4 listed)
- Intracranial hemorrhage on neuroimaging.
- Severe impairment of consciousness judged by the investigator to preclude safe participation.
- Persistent blood pressure >220/120 mmHg after initial medical management.
- Severe systemic disease that, in the investigator's judgment, may interfere with study participation or safety.
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 |
|---|---|---|
| Capsaicin Transmucosal Oral FilmA dissolvable transmucosal oral film containing a low dose of capsaicin designed for local administration in the oral cavity. The formulation is intended to provide controlled mucosal exposure to capsaicin for investigational neuromodulatory stimulation of trigeminal-parasympathetic pathways potentially involved in cerebral blood flow regulation. The film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke. | Drug | Transmucosal Capsaicin |
| Placebo Transmucosal Oral FilmA dissolvable transmucosal oral film identical in appearance, texture, and administration method to the active study film but without capsaicin. The placebo film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke to maintain blinding. | Drug | Placebo Oral Film |
Primary outcome
Incidence of Adverse Events Within 72 Hours After Administration
Time frame: 72 hours after study intervention administration
The primary outcome is the proportion of participants experiencing any adverse event within 72 hours after administration of the study oral film. Adverse events include any unfavorable clinical sign, symptom, or change in vital signs temporally associated with study treatment, regardless of causality. Vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) are recorded at predefined time points during the first 72 hours.
3 secondary outcomes
Change in Systolic Blood Pressure Over 72 Hours
Time frame: Baseline (pre-dose) through 72 hours post-dose
Change in Heart Rate Over 72 Hours
Time frame: Baseline (pre-dose) through 72 hours post-dose
Treatment Tolerability Within 72 Hours
Time frame: Up to 72 hours post-dose
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 17 Feb 2026.
- Background: PubMed 33966493Marquez-Romero JM, Huerta-Franco MR, Vargas-Luna M, Madrigal-Gutierrez CA, Esparza-Hernandez JM, Velazquez-Barcena MG. Dose Escalation and Safety of Capsaicin for Cerebral Perfusion Augmentation: A Pilot Study. Stroke. 2021 Jul;52(7):2203-2209. doi: 10.1161/STROKEAHA.120.032773. Epub 2021 May 10.
- Background: PubMed 38456262Marquez-Romero JM, Garcia-Perales C, Garcia-Arellano M, Ortiz MS, Perez-Malagon CD, Huerta-Franco MR, Vargas-Luna FM. Capsaicin for Cerebral Perfusion Augmentation: A Randomized Open-Label Trial. Stroke. 2024 Apr;55(4):e112-e114. doi: 10.1161/STROKEAHA.123.046045. Epub 2024 Mar 8. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, subject to institutional approval, data use agreements, and applicable privacy regulations.
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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 Phase 2 study testing Capsaicin Transmucosal Oral Film in people with Ischemic Stroke, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 5 inclusion and 4 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 17 Feb 2026. 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 Mexico. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Juan M Marquez-Romero, MD, PhD (+524499136423, scint1st@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events Within 72 Hours After Administration (time frame: 72 hours after study intervention administration). 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 NCT07406971, which also lists 2 linked publications.
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 17 Feb 2026.