Spp-004 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 21 | ミトコンドリア病 | 4 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JMA-IIA00406 | 01/02/2019 | 18/01/2019 | Long-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 system | Intervention 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 Hospital | NULL | Recruiting | >=9 MONTHS | No Limit | BOTH | 55 | Phase 3 | Japan |
| 2 | JPRN-JMA-IIA00358 | 30/06/2018 | 22/06/2018 | Multicenter 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 system | Intervention 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 Hospital | NULL | Completed | >=3 MONTHS | No Limit | BOTH | 40 | Phase 3 | Japan |
| 3 | JPRN-JMA-IIA00214 | 02/06/2015 | 26/05/2015 | Long-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 symptoms | Intervention 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 Hospital | NULL | Completed | >=9 MONTHS | <30 MONTHS | BOTH | 10 | Phase 2 | Japan |
| 4 | JPRN-JMA-IIA00200 | 10/12/2014 | 09/12/2014 | Multicenter trial of SPP-004 in mitochondrial diseases | Multicenter trial of SPP-004 in mitochondrial diseases | Mitochondrial disease, mainly to cranial nerve symptoms | Intervention 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 Hospital | NULL | Completed | >=3 YEARS | <2 YEARS | BOTH | 10 | Phase 2 | Japan |