PUBLIC DISCLOSURE FOR CLINICAL STUDY EGL-4104-C-1702
Intoxication resulting from the use of certain illicit psychostimulant drugs may lead to a life-threatening medical condition in which the person experiences a severe increase in body temperature, metabolic abnormalities, rapid heart rate, aggressiveness, delusions, convulsions, or even coma. These illicit psychostimulant drugs are commonly taken at large mass gathering events such as outdoor electronic dance music festivals.
The current standard treatment of this serious condition is limited to body cooling by external methods and implementation of supportive measures, such as intravenous fluids and respiratory support. There is no pharmacologic drug product approved for treatment of this condition.
Eagle Pharmaceuticals, Inc., is conducting a clinical study at select music festivals to investigate the safety and efficacy of Ryanodex® (dantrolene sodium) for the treatment of acute toxicity induced by the use of illicit psychostimulant drugs, such as methamphetamine (“Meth”), or methylenedioxymethamphetamine (MDMA, Molly, or Ecstasy). Dantrolene sodium has a wide therapeutic window, with daily exposures of up to 10 mg/kg being generally safe and well-tolerated.
Ryanodex is currently approved in the United States for the treatment of Malignant Hyperthermia (MH) in conjunction with appropriate supportive measures. MH is a rare, life-threatening condition that can occur after the use of certain anesthetics and muscle relaxants and shares some of the same signs and symptoms observed in people with acute intoxication by psychostimulant drugs.
For implementation of this clinical study, Eagle Pharmaceuticals has partnered with CrowdRx, Inc., a New York based firm, who is a leading providers of health services at mass gathering events nationwide, with vast experience at large music festivals in addition to sports and entertainment venues.
The clinical study will enroll approximately 100 people. Potential study participants will be identified from those presenting to Pre-hospital Emergency Care (PHEC) units at the music festivals. These PHEC units are fully equipped and staffed to provide adequate medical care to people with psychostimulant drug-induced toxicity. Eligible study participants will be assigned randomly and will have an equal chance to receive treatment with Ryanodex in addition to standard treatment or receive the standard treatment only.
Each participant’s stay in the study is expected to last up to 6 hours. Study participants will receive study-related care from a doctor/research team at no cost for the duration of their study participation.
Further information about this clinical study can be found at:
Information about this clinical study can also be obtained by calling anytime toll-free at 1-888-701-0565 or via e-mail at firstname.lastname@example.org