Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
29
Countries
1
Sites
1
Migraine
The main objective of this study is to investigate the role of the intracellular messenger cAMP in migraine by exploring potential sex-related differences in the response to cilostazol in individuals with migraine.
Key facts
- Sponsor
- Syddansk Universitet (University of Southern Denmark)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 21 Nov 2025 → ongoing
- Decision date (initial)
- 2025-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Oda og Hans Svenningsens Fond
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The main objective of this study is to investigate the role of the intracellular messenger cAMP in migraine by exploring potential sex-related differences in the response to cilostazol in individuals with migraine.
Conditions and MedDRA coding
Migraine
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Healthy men and women with a diagnosis of episodic migraine without aura according to the International Classification
- Age: 18-65 years
- Weight: 50-100 kg
- Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) for women during the entire period of the study
- Fluency in Danish or English
Exclusion criteria 14
- Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
- Concomitant use of anticoagulants, antiaggregants and drugs that inhibit CYP3A4 and CYP2C19 activity
- Positive pregnancy test at the Screening and/or before the start of the experiment
- Known allergy to any component of cilostazol “Aliud”
- Member of investigational site staff or relative of investigators
- Headache less than 24 hours before the start of the experiment
- Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment
- Assumption of analgesic medications in the 24 hours preceding the experimental days
- Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit
- History or clinical signs of cardiovascular disease, cardiac arrhythmia, unstable angina pectoris, impaired liver function and/or kidney function
- Recent history of myocardial infarction or major cardiac surgery
- Anamnestic or clinical signs of mental illness, abuse or smoking
- Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
- Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The difference in the incidence of migraine-like attacks during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura
- The difference in the incidence of migraine-like attacks during the entire observational period (until 12 hours post-administration) between cilostazol-treated men and women with migraine without aura
Secondary endpoints 3
- The difference in the incidence of headache during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura
- Difference in heart rate and mean arterial pressure until 90 minutes post-administration between cilostazol- and placebo-treated men with migraine without aura
- Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between cilostazol- and placebo-treated men with migraine without aura
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cilostazol AL 100 mg Tabletten
PRD1863912 · Product
- Active substance
- Cilostazol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- B01AC23 — -
- Marketing authorisation
- 89798.00.00
- MA holder
- ALIUD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The preparation of placebo is performed at the hospital pharmacy of Herlev.
Auxiliary 2
Ibuprofen Teva 400 mg, omhulde tabletten
PRD590961 · Product
- Active substance
- Ibuprofen
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- M01AE01 — IBUPROFEN
- Marketing authorisation
- RVG 09590
- MA holder
- TEVA NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sumatriptan Accord 100 mg, filmomhulde tabletten
PRD1168824 · Product
- Active substance
- Sumatriptan Succinate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- N02CC01 — SUMATRIPTAN
- Marketing authorisation
- RVG 113184
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Syddansk Universitet (University of Southern Denmark)
- Sponsor organisation
- Syddansk Universitet (University of Southern Denmark)
- Address
- Campusvej 55
- City
- Odense M
- Postcode
- 5230
- Country
- Denmark
Scientific contact point
- Organisation
- Syddansk Universitet (University of Southern Denmark)
- Contact name
- Lanfranco Pellesi
Public contact point
- Organisation
- Syddansk Universitet (University of Southern Denmark)
- Contact name
- Lanfranco Pellesi
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 29 | 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 |
|---|---|---|---|---|---|
| Denmark | 2025-11-21 | 2025-12-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2025-521520-29-00_signed | 1 |
| Protocol (for publication) | D4_ Appendix 1_Hovedpineskema_0-90 | 1 |
| Protocol (for publication) | D4_ Appendix 2_Hovedpineskema_derhjemme | 1 |
| Protocol (for publication) | D4_ Appendix 3_Raskscreeningsark | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF adults | 1 |
| Subject information and informed consent form (for publication) | L2_ Information leaflet men | 2 |
| Subject information and informed consent form (for publication) | L2_ Information leaflet women | 2 |
| Subject information and informed consent form (for publication) | L2_ Information rettigheder | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ Cilostazol_AL_SmPC | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis 2025-521520-29-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-29 | Denmark | Acceptable 2025-06-20
|
2025-06-20 |