21. ミトコンドリア病 Mitochondrial disease Clinical trials / Disease details


臨床試験数 : 39 薬物数 : 42 - (DrugBank : 32) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 67

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JMA-IIA00406
01/02/201918/01/2019Long-term, multicenter trial of SPP-004 in mitochondrial diseases(after confirmation trial)Long-term, multicenter trial of SPP-004 in mitochondrial diseases(after confirmation trial) Mitochondrial disease, involved mainly central nervous systemIntervention type:DRUG. Intervention1:SPP-004, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:5-ALA HCl and SFC capsules are administered orally or by a feeding tube in accordance with doses and frequency of administration based on body weight at screening and each observation time during the period of treatment.If capsules cannot be swollen, the content should be dissolved at the time of administration.. Control intervention1:-, Intended dose regimen:-.Saitama Medical University HospitalNULLCompleted>=9 MONTHSNo LimitBOTH55Phase 3Japan
2JPRN-JMA-IIA00358
30/06/201822/06/2018Multicenter trial of SPP-004 in mitochondrial diseases (confirmatory trial)Multicenter trial of SPP-004 in mitochondrial diseases (confirmatory trial) Mitochondrial disease, involved mainly central nervous systemIntervention type:DRUG. Intervention1:SPP-004, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Open period
A capsule of each investigational drug (5-ALA HCl capsule (25 mg) and SFC capsule (39.22 mg)) is administered orally or by a feeding tube. If capsules cannot be swollen, the content should be dissolved at the time of administration.
Double-blind period.
Same dose in open period is administered orally or by a feeding tube. If capsules cannot be swollen, the content should be dissolved at the time of administration.
Through the study treatment (open period and double-blind period), doses are based on the body weight at observation time during the treatment period.. Control intervention1:Placebo, Dose form:CAPSULE, Route of administration:ORAL, Intended dose regimen:Open period
A capsule of each investigational drug (5-ALA HCl capsule (25 mg) and SFC capsule (39.22 mg)) is administered orally or by a feeding tube. If capsules cannot be swollen, the content should be dissolved at the time of administration.
Double-blind period.
Same dose in open period is administered orally or by a feeding tube. If capsules cannot be swollen, the content should be dissolved at the time of administration.
Through the study treatment (open period and double-blind period), doses are based on the body weight at observation time during the treatment period..
Saitama Medical University HospitalNULLCompleted>=3 MONTHSNo LimitBOTH40Phase 3Japan
3JPRN-JMA-IIA00214
02/06/201526/05/2015Long-term, multicenter trial of SPP-004 in mitochondrial diseases.Long-term, multicenter trial of SPP-004 in mitochondrial diseases. Mitochondrial disease, mainly to cranial nerve symptomsIntervention type:DRUG. Intervention1:SPP-004, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:5-ALA HCl and SFC capsules are administered orally or by a feeding tube in accordance with doses and frequency of administration based on body weight at each observation time during the period of treatment. If capsules cannot be swollen, the content should be dissolved at the time of administration..Saitama Medical University HospitalNULLCompleted>=9 MONTHS<30 MONTHSBOTH10Phase 2Japan
4JPRN-JMA-IIA00200
10/12/201409/12/2014Multicenter trial of SPP-004 in mitochondrial diseasesMulticenter trial of SPP-004 in mitochondrial diseases Mitochondrial disease, mainly to cranial nerve symptomsIntervention type:DRUG. Intervention1:SPP-004, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:A capsule of each investigational drug [5-ALA HCl capsule (25 mg) and SFC capsule (39.22 mg)] is administered twice a day orally or by a feeding tube . After Week 13, a capsule of each investigational drug (5-ALA HCl capsule and SFC capsule) is administered twice a day orally and by a feeding tube. If capsules cannot be swollen, the content should be dissolved at the time of administration.. Control intervention1:Placebo, Dose form:CAPSULE, Route of administration:ORAL, Intended dose regimen:A capsule of each investigational drug [5-ALA HCl placebo capsule (25 mg) and SFC capsule (39.22 mg)] is administered twice a day orally or by a feeding tube.
If capsules cannot be swollen, the content should be dissolved at the time of administration.
.
Saitama Medical University HospitalNULLCompleted>=3 YEARS<2 YEARSBOTH10Phase 2Japan