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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03108469 | Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine | PHASE2 | COMPLETED | 30 | — | — | Aug 1, 2017 | Apr 26, 2019 | Feb 12, 2020 | 2 | United States |
Compare the efficacy of ISIS 546254 in the preventive treatment of chronic migraine, measured by the number of monthly migraine days comparing baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo.
| Arm | Type | Description |
|---|---|---|
| IONIS-PKKRx (ISIS 546254) | ACTIVE_COMPARATOR | Those randomized to IONIS-PKKRx (ISIS 546254) will receive subcutaneous injections containing 1.00 mL (200mg) weekly for weeks 1-16. |
| Placebo | PLACEBO_COMPARATOR | Those randomized to placebo will receive subcutaneous injections containing 1.00 mL (200mg) weekly for weeks 1-16. |
| Name | Type | Description |
|---|---|---|
| IONIS-PKKRx (ISIS 546254) | DRUG | Those randomized to IONIS-PKKRx (ISIS 546254) will receive subcutaneous injections containing 1.00 mL (200mg) of IONIS- PKKRx (ISIS 546254) weekly for weeks 1-16. |
| Placebo | OTHER | Those randomized to placebo will receive subcutaneous injections 1.00 mL (200mg) weekly for weeks 1-16. |
Inclusion Criteria: Potential subjects must meet the following criteria at the screening visit to enter this study: 1. male or female, in otherwise good health, 18 to 65 years of age. 2. history of chronic migraine meeting the diagnostic criteria listed in the International Classification of Heada...