JPRN-jRCT2031230317
Recruiting
Phase 3
A phase III study (physician-initiated clinical trial) to evaluate the efficacy and safety of sirolimus for epileptic seizures with focal cortical dysplasia type II
Kato Mituhiro0 sites20 target enrollmentSeptember 4, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- focal cortical dysplasia type II
- Sponsor
- Kato Mituhiro
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients with a diagnosis of focal cortical dysplasia type II (including hemimegalencephaly) based on neuroimaging findings by head MRI within 156 weeks prior to enrollment or brain pathology prior to enrollment
- •(2\) Patients aged 1 year or older at the time of consent
- •(3\) Patients diagnosed with focal motor onset seizures (with motor signs which are able to be confirmed by others) or focal to bilateral tonic\-clonic seizures associated with FCD based on the operational classification of seizure types by the International League Against Epilepsy (ILAE) 2017 (Appendix 1\)
- •(4\) Patients who have been treated with at least 2 antiepileptic drugs for at least 26 weeks since the diagnosis of epilepsy
- •(5\) Patients on treatment with 1 to 4 antiepileptic drugs at the time of consent
- •(6\) Patients whose dosage and administration of antiepileptic drugs has been constant for 8 weeks prior to enrollment
- •(7\) Patients whose vagal nerve stiumulation therapy stimulation conditions have been constant for 8 weeks prior to enrollment
- •(8\) Patients with at least 2 focal motor onset seizures (with motor signs which are able to be confirmed by others) or focal to bilateral tonic\-clonic seizures during the 28\-day baseline observation period
- •(9\) Patients who provide written consent to participate in this study from the patient or a surrogate (parent or legal guardian).
Exclusion Criteria
- •(1\)Patients who have participated in another clinical trial within 12 weeks prior to obtaining consent
- •(2\)Patients who have taken sirolimus or everolimus within 52 weeks prior to enrollment
- •(3\)Patients in whom neither the patient nor a surrogate can accurately record the number and duration of seizures
- •(4\)Patients suspected of having progressive brain lesions on computed tomography(CT)or magnetic resonance imaging(MRI)performed to date
- •(5\)Patients who have undergone neurosurgery for epilepsy(focal resection, cortical resection, functional hemispherectomy, corpus callosotomy, vagus nerve stimulation, or electrode implantation)within 26 weeks prior to enrollment
- •(6\)Patients who are taking or have taken felbamate or vigabatrin within 26 weeks prior to enrollment
- •(7\)Patients on a ketogenic diet
- •(8\)Patients with previous suicide attempts
- •(9\)Patients with a history or complications of substance abuse(including alcohol abuse)
- •(10\)Patients of childbearing potential or male patients with a partner of childbearing potential who cannot agree to use contraception from the time of consent until 12 weeks after completion of study medication, patients who are pregnant or lactating, or patients who may be pregnant
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
N/A
Prelude A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - NDEUCTR2005-004630-41-ITELI LILLY459
Recruiting
Phase 3
A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand diseaseCoagulation disorderHereditary deficiency of Von Willebrand Factor in blood1006447710005330NL-OMON38008Baxter4
Active, Not Recruiting
N/A
Assessment of the efficacy of PGL4001 in repeated treatment courses on reducing symptoms of uterine fibroids causing heavy menstrual periodsterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.MedDRA version: 14.0Level: LLTClassification code 10046801Term: Uterine myomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]EUCTR2010-019497-32-PLPregLem S.A.200
Active, Not Recruiting
N/A
PGL4001 Efficacy Assessment in Reduction of symptoms due to uterine Leiomyomataterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.MedDRA version: 14.0Level: LLTClassification code 10046801Term: Uterine myomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]EUCTR2010-018999-25-ATPregLem S.A.200
Active, Not Recruiting
Phase 1
A Phase III, multicentre, clinical study investigating the efficacy and safety of 3-months open-label treatment with PGL4001, followed by a randomised, double-blind placebo controlled period of 10 days treatment with progestin, in subjects with myomas and heavy uterine bleeding. - PEARL III: PGL4001 Efficacy Assessment in Reduction of symptoms due to uterine Leiomyomataterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.MedDRA version: 12.1Level: LLTClassification code 10046801Term: Uterine myomaEUCTR2010-018999-25-BEPregLem S.A.200