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Also known as IONIS-PKKRx (ISIS 546254)
IONIS-PKKRx · 1 trial · 1 indication
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...
IONIS-PKKRx is an investigational drug being developed for the preventive treatment of chronic migraine. It is not approved for any indication and remains in clinical development. Chronic migraine is a neurological condition characterized by headaches occurring on 15 or more days per month, with migraine features on at least 8 of those days.
IONIS-PKKRx is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. The company is the sponsor of the clinical program evaluating the drug for chronic migraine prevention.
IONIS-PKKRx is in Phase 2 clinical development for chronic migraine. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
IONIS-PKKRx has been studied in one completed Phase 2 trial, NCT03108469, titled "Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine." The trial enrolled 30 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older of all sexes.
Yes, IONIS-PKKRx is also known as ISIS 546254. The two names refer to the same investigational compound developed by Ionis Pharmaceuticals for chronic migraine prevention. The ISIS prefix reflects the company's earlier corporate name, Isis Pharmaceuticals, which was later changed to Ionis Pharmaceuticals.