Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dantrolene sodium for injectable suspension
Dantrolene for injectable · 1 trial · 1 indication
Number of subjects achieving a Glasgow Coma Scale(GCS) ≥ 13 at or prior to 90 minutes post-randomization. The Glasgow Coma Scale (GCS) is a reliable and objective way of recording the initial and subsequent level of consciousness in a person after a brain injury. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score\*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe. \*Subscales: Eyes Response -Spontaneous=4; To sound =3; To Pressure=2; None=1; not tested. Verbal Response- Oriented=5; Confused=4; Words=3; Sounds=2; None-1; Not tested. Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested.
| Arm | Type | Description |
|---|---|---|
| Ryanodex | EXPERIMENTAL | Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment. |
| Standard of Care only (SOC) | NO_INTERVENTION | Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately. |
| Name | Type | Description |
|---|---|---|
| Dantrolene sodium for injectable suspension | DRUG | Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg. |
Inclusion Criteria: * Subjects may be entered in the study if they have a core body temperature obtained rectally of ≥ 40.0°C (104°F) * Recent history or suspected recent history (prior 24 hours) of performing intense physical activity (exertional activity) * The subject has an impaired consciousne...
Top 4 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 1 | PHASE3 | Milvexian |
| DiaMedica Therapeutics Inc. | DMAC | 1 | PHASE3 | DM199 |
| Grace Therapeutics, Inc. | GRCE | 1 | PHASE3 | GTX-104 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | TAK-755 |