Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
5
Migraines with aura
To evaluate the efficacy of amiloride (non-specific ASIC-1 channel blocker) in the prophylaxis of migraine aura.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 13 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516044-25-00
- EudraCT number
- 2017-001288-18
- ClinicalTrials.gov
- NCT04063540
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the efficacy of amiloride (non-specific ASIC-1 channel blocker) in the prophylaxis of migraine aura.
Secondary objectives 5
- To evaluate the efficacy of amiloride (a non-specific ASIC-1 channel blocker) in the migraine headache prophylaxis
- Evaluate the efficacy of amiloride (a non-specific ASIC-1 channel blocker) by measuring functional functional impact in the prophylaxis of migraine with aura.
- Evaluate the efficacy of amiloride (a non-specific ASIC-1 channel blocker) by measuring functional emotional impact in the prophylaxis of migraine with aura.
- To evaluate the efficacy of amiloride (a nonspecific ASIC-1 channel blocker) by the in the prophylaxis of migraine with aura.
- To evaluate the safety of amiloride (a non-specific ASIC-1 channel blocker) in the prophylaxis of migraine with aura.
Conditions and MedDRA coding
Migraines with aura
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027601 | Migraine aura | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Subjects aged 18 to 80
- Male or female
- Diagnosis of migraine with aura code 1.2.1 according to ICHD-3 including codes 1.2.1.1 and 1.2.1.2
- At least 1 attack with aura per month in the 3 months prior to inclusion
- Absence of prophylactic background antimigraine treatment for at least 1 month prior to inclusion
- For women of childbearing age, use of a reliable contraceptive method at least at least 3 months before and 1 month after the study
- Signature of written informed consent
- Patient affiliated to social security
Exclusion criteria 6
- Existence of contraindications to the use of amiloride
- Cardiovascular and renal history, for subjects over 75 years of age
- Athletes likely to be tested in competition and/or training
- Patients who, from the investigator's point of view, would not be compliant with the study procedure
- Pregnant or breast-feeding patients
- Patients under guardianship, curatorship or protected by law
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of seizures with aura, with or without headache
Secondary endpoints 6
- Number of days with migraine headache, with or without aura
- Number of days with any type of headache, with or without aura
- Functional impact (impact score on HIT-6 scale)
- Emotional impact (anxiety and depression score on the HAD scale)
- Health status (EQ-5D scale score)
- Occurrence or absence of significant or unknown adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9041755 · Product
- Active substance
- Amiloride Hydrochloride Dihydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C03DB01 — AMILORIDE
- Marketing authorisation
- 34009 315 020 8 1
- MA holder
- SUBSTIPHARM
- MA country
- France
- 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
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dr Michel LANTERI-MINET
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Maeva GODEMERT
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Jean Perrin
Neurologie, 58 Rue Montalembert, 63000, Clermont-Ferrand
Hospices Civils De Lyon
Neurologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Montpellier
Neurologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Regional De Marseille
Neurosciences, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nice
Evaluation de la douleur, 4 Avenue Reine Victoria, 06000, Nice
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 |
|---|---|---|---|---|---|
| France | 2020-08-11 | 2024-10-17 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-54273
- Halt date
- 2024-08-17
- Planned restart
- 2024-12-02
- Member states concerned
- France
- Publication date
- 2024-10-28
- Reason
- Medicinal Product related
- Explanation
- MP supply issues
- Follow-up measures
- Patients allready included may be followed as per protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516044-25-00 | 5.1 |
| Protocol (for publication) | D1_PROTOCOL_2024-516044-25-00_FP | 6.0 |
| Protocol (for publication) | D1_PROTOCOL_2024-516044-25-00_FP_sma | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | NA_Part II | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient | 5.1 |
| Subject information and informed consent form (for publication) | Li_SIS and ICF Adults_2024-516044-25-00_FP | 6.0 |
| Subject information and informed consent form (for publication) | Li_SIS and ICF Adults_2024-516044-25-00_FP_sma | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Modamide | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS_2024-516044-25-00_FP | 6.0 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS_2024-516044-25-00_FP_sma | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-516044-25-00 | 5.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | France | Acceptable 2024-10-03
|
2024-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-05 | France | Acceptable 2025-03-17
|
2025-04-18 |