Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02383511 | Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet | PHASE1 | COMPLETED | 12 | — | — | Feb 1, 2015 | Aug 1, 2015 | Aug 26, 2015 | 4 | United Kingdom |
To determine the plasma concentration of SMT C1100 parent and the major metabolites calculated at each time point for each subject.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | OTHER | Drug: SMT C1100 or placebo 3-treatment (Period 1,2 and 3) |
| Sequence 2 | OTHER | Drug: SMT C1100 or placebo 3-treatment (Period 1,2, and 3) |
| Sequence 3 | OTHER | Drug: SMT C1100 or placebo 3-treatment (Period 1,2 and 3) |
| Name | Type | Description |
|---|---|---|
| SMT C1100 | DRUG | Period 1, SMT C1100 1250 mg BID; Period 2, Placebo BID; Period 3, SMT C1100 2500 mg BID |
Inclusion Criteria: 1. Patients will be males of any ethnic origin with a genetic diagnosis of DMD. 2. Children between 5 and 13 years of age. 3. A parent/legal guardian must date and sign a written consent on behalf of the patient, according to International Conference on Harmonisation (ICH) and l...