Overview
Sponsor-declared trial summary
Migraine
- Temporal Evolution of Biochemical Marker Levels in Blood and Saliva During NTG-Induced Migraine Attacks and After Treatment with Sumatriptan and Rimegepant - Correlation of Biochemical Marker Profiles with Acute Treatment Response to Sumatriptan and Rimegepant During NTG-Induced Migraine Attacks.
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Mar 2026 → ongoing
- Decision date (initial)
- 2025-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto de Salud Carlos III
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others
- Temporal Evolution of Biochemical Marker Levels in Blood and Saliva During NTG-Induced Migraine Attacks and After Treatment with Sumatriptan and Rimegepant
- Correlation of Biochemical Marker Profiles with Acute Treatment Response to Sumatriptan and Rimegepant During NTG-Induced Migraine Attacks.
Conditions and MedDRA coding
Migraine
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027599 | Migraine | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adults between 18 and 60 years old.
- Diagnosis of migraine, with or without aura, according to the The International Classification of Headache Disorders 3rd edition.
- According to the calendar, frequency of cefalea < 10 days/month.
- Signature of the Inform Consent Form.
Exclusion criteria 10
- Contraindication to nitroglycerin
- History of poor tolerance or prior hypersensitivity reaction to triptans or gepants
- History of severe or refractory migraine attacks unresponsive to treatment with triptans, gepants, or NSAIDs
- Preventive treatment for migraines (includes antidepressants, beta-blockers, lisinopril or candesartan, topiramate, valproic acid, botulinum toxin, or CGRP-targeted therapies).
- Tretament with drugs acting on the central nervous system
- Relevant medical or psychiatric diseases
- History of unstable ischemic heart disease, cerebrovascular disease, peripheral vasculopathy
- History of significant hepatic disease
- Pregnant women
- Child-bearing women that not use one acceptable method of birth contro
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Temporal evolution of GRP, AMY , VIP and PACAP-38 levels in blood and saliva (4 time points: Basal, begging migraine; peak-migraine; 2 hours post migraine treatment)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP116462429 · ATC
- Active substance
- Sumatriptan
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02CC01 — SUMATRIPTAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP56449652 · ATC
- Active substance
- Rimegepant
- Substance synonyms
- BMS927711, BHV-3000, BMS-927711, (5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA(B)PYRIDIN-9-YL 4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO(4,5-B)PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02CD06 — RIMEGEPANT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SCP1127655 · ATC
- Active substance
- Isosorbide Dinitrate
- Substance synonyms
- ISDN
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.5 µg/Kg microgram(s)/kilogram
- Max total dose
- 10 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01DA02 — GLYCERYL TRINITRATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Marta Torres Ferrús
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Marta Torres Ferrús
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-03-05 | 2026-04-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol ESP EU CT 2024-519770-38-00 | 1 |
| Protocol (for publication) | D1_Protocolo_EU CT 2024-519770-38-00_Spanish_cc | 1 |
| Protocol (for publication) | D1_Protocolo_EU CT 2024-519770-38-00_Spanish_clean | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF General_cc | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF General_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rimegepant | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sumatriptan | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis EU CT 2024-519770-38-00_cc | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis EU CT 2024-519770-38-00_clean | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis EU CT 2024-519770-38-00_Spanish_cc | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis EU CT 2024-519770-38-00_Spanish_clean | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG_EU CT 2024-519770-38-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP_EU CT 2024-519770-38-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-21 | Spain | Acceptable 2025-04-01
|
2025-04-01 |