Clinical trial • Other
Amiloride hydrochloride dihydrate for Migraine with aura
Clinical trial of Amiloride hydrochloride dihydrate for Migraine with aura.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Migraine with aura
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 17-10-2024
Trial design
Placebo: Tablets for oral use; Test: MODAMIDE 5 mg (amiloride hydrochloride dihydrate) tablet (product lists max daily dose 10 mg; schedule not specified)-controlled trial across 5 sites in France.
- Comparator
- Placebo: Tablets for oral use; Test: MODAMIDE 5 mg (amiloride hydrochloride dihydrate) tablet (product lists max daily dose 10 mg; schedule not specified)
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population not selected. Patients under guardianship, curatorship or protected by law are explicitly excluded. Only adults aged 18 to 80 are eligible. Written informed consent by the participant is required (adult ICFs shown in documents)..
- Pregnancy Exclusion
- Pregnant or breast-feeding patients
- Vulnerable Population
- Vulnerable population not selected. Patients under guardianship, curatorship or protected by law are explicitly excluded. Only adults aged 18 to 80 are eligible. Written informed consent by the participant is required (adult ICFs shown in documents).
Inclusion criteria
- {"criterion_text":"- Subjects aged 18 to 80\n- Male or female\n- Diagnosis of migraine with aura code 1.2.1 according to ICHD-3 including codes 1.2.1.1 and 1.2.1.2\n- At least 1 attack with aura per month in the 3 months prior to inclusion\n- Absence of prophylactic background antimigraine treatment for at least 1 month prior to inclusion\n- For women of childbearing age, use of a reliable contraceptive method at least at least 3 months before and 1 month after the study\n- Signature of written informed consent\n- Patient affiliated to social security"}
Exclusion criteria
- {"criterion_text":"- Existence of contraindications to the use of amiloride\n- Cardiovascular and renal history, for subjects over 75 years of age\n- Athletes likely to be tested in competition and/or training\n- Patients who, from the investigator's point of view, would not be compliant with the study procedure\n- Pregnant or breast-feeding patients\n- Patients under guardianship, curatorship or protected by law"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of seizures with aura, with or without headache","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Number of days with migraine headache, with or without aura","definition_or_measurement_approach":"Count of days with migraine headache (with or without aura) during assessment periods"}
- {"endpoint_text":"- Number of days with any type of headache, with or without aura","definition_or_measurement_approach":"Count of days with any type of headache (with or without aura) during assessment periods"}
- {"endpoint_text":"- Functional impact (impact score on HIT-6 scale)","definition_or_measurement_approach":"Measured using the HIT-6 impact score"}
- {"endpoint_text":"- Emotional impact (anxiety and depression score on the HAD scale)","definition_or_measurement_approach":"Measured using the Hospital Anxiety and Depression (HAD) scale"}
- {"endpoint_text":"- Health status (EQ-5D scale score)","definition_or_measurement_approach":"Measured using the EQ-5D health status questionnaire"}
- {"endpoint_text":"- Occurrence or absence of significant or unknown adverse events","definition_or_measurement_approach":"Adverse event monitoring and reporting (occurrence/absence of notable or unknown AEs)"}
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 64
- Consent Approach
- Written informed consent required from each participant. Only adults (18-80) are eligible; adult-specific ICF and subject information documents are provided (documents labelled 'SIS and ICF Adults'). Documents/translations available in French.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 40
France
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 18-04-2025
- Processing Time Days
- 193
- Number Of Sites
- 5
- Number Of Participants
- 40
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Neurosciences
- Contact Person Name
- Anne DONNET
- Contact Person Email
- adonnet@ap-hm.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Neurologie
- Contact Person Name
- Xavier MOISSET
- Contact Person Email
- xmoisset@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Neurologie
- Contact Person Name
- Anne DUCROS
- Contact Person Email
- a-ducros@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Evaluation de la douleur
- Contact Person Name
- michel LANTERI-MINET
- Contact Person Email
- lanteri-minet.m@chu-nice.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neurologie
- Contact Person Name
- Geneviève DEMARQUAY
- Contact Person Email
- genevieve.demarquay@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nice
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- MODAMIDE 5 mg, comprimé
- Active Substance
- Amiloride hydrochloride dihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present in France (marketingAuthNumber: 34009 315 020 8 1)
- Dose Levels
- 5 mg tablet; product lists max daily dose 10 mg
- Maximum Dose
- 10 mg per day
- Investigational Product Name
- Tablets for oral use
- Modality
- Other
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