Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Status:
Terminated
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
Ryanodex is being investigated as a potential adjuvant treatment for people suffering from
psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that
results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and
related forms (MDMC or "Molly"; MDMA or "Ecstasy"). Ryanodex is approved for the treatment of
malignant hyperthermia in conjunction with appropriate supportive measures and for prevention
of malignant hyperthermia in patients at high risk and in this study, will be investigated
for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as
adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with
SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as
body cooling and supportive measures.