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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 small molecule being developed for the preventive treatment of chronic migraine. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is intended for patients with chronic migraine, a neurological condition characterized by frequent headaches.
IONIS-PKKRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the preventive treatment of chronic migraine.
IONIS-PKKRx is in Phase 2 clinical development. A Phase 2 trial has been completed, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not received FDA approval. Further clinical development would be needed before any regulatory submission.
IONIS-PKKRx has one completed clinical trial, identified as NCT03108469. This Phase 2 study evaluated the efficacy and safety of IONIS-PKKRx for the preventive treatment of chronic migraine. The trial enrolled 30 participants in the United States, with a minimum age of 18 years.
No, IONIS-PKKRx is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval. It remains under investigation for the preventive treatment of chronic migraine.