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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01307332 | Advanced MRI Measures of Repair in Alemtuzumab Treated Patients | PHASE3 | COMPLETED | 27 | — | — | Mar 1, 2011 | Sep 28, 2018 | Oct 16, 2018 | 1 | Canada |
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
| Arm | Type | Description |
|---|---|---|
| MabCampath-1h | EXPERIMENTAL | Single arm, single cohort study, all subjects will be dosed with alemtuzumab. |
| Name | Type | Description |
|---|---|---|
| MabCampath-1h | DRUG | Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days. |
Inclusion Criteria: * Signed, informed consent form * Age 18 to 50 years old (inclusive) * Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening * Onset of MS symptoms within 15 years of screening * N...