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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01892722 | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 240 | — | — | Jul 26, 2013 | Feb 18, 2030 | Jun 8, 2026 | 73 | United States, Australia +23 |
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
| Arm | Type | Description |
|---|---|---|
| Fingolimod | EXPERIMENTAL | Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment |
| Interferon beta-1a | ACTIVE_COMPARATOR | An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase |
| Fingolimod-Younger Cohort | EXPERIMENTAL | The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage \<2) |
| Name | Type | Description |
|---|---|---|
| Interferon beta-1a | DRUG | Administration once weekly via i.m. injections. |
| Fingolimod | DRUG | Administrated orally once daily: 0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less. |
| Placebo capsule | DRUG | Matching placebo capsule required for double-dummy masking to blind formulations. |
| Placebo i.m. injection | DRUG | Matching placebo i.m. injection required for double-dummy masking to blind formulations. |
Key Inclusion Criteria Core Phase: * diagnosis of multiple sclerosis * at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive Key Exclusion Criteria Core Phase: * pati...