Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Condition: Drug Toxicity Psychotropic Agents Psychostimulants
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Intervention: Ryanodex (dantrolene sodium) for injectable suspension
Intervention description: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL.
Intervention MeSH terms: Dantrolene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria: Male and non-pregnant subjects diagnosed with psychostimulant drug
        induced toxicity as evidenced by all of the following: core body temperature of greater
        than or equal to 39.5 degrees C; organ dysfunction, as evidenced by a Logistic Organ
        Dysfunction System score of greater than or equal to 6 (In the event of any delay in
        obtaining the results for baseline LODS score determination, subject may be enrolled. After
        enrollment, if the pending baseline LODS score turns out to be less than 6, the subject
        will be withdrawn from the study and replaced); known or suspected us of a psychostimulant
        drug in the judgment of the Investigator; negative blood pregnancy test for females (in the
        event of any delay in obtaining pregnancy test result, subject may be enrolled and
        randomized if all of the other eligibility criteria are met).

        Exclusion Criteria: Diagnosed with or is suspected to have an acute, clinically severe
        infection, which may, in the opinion of the Investigator, may increase the subject's risk
        for participating in the study an/or may impair the ability of performing and/or
        interpreting study assessments; severe hyperthermia secondary to a condition other than a
        psychostimulant drug-induced toxicity; likelihood of head trauma in the past 3 months, or
        other systemic disease that might increase the subject's risk for participating in the
        study and/or may impair the ability of performing and/or interpreting study assessments;
        positive pregnancy test or evidence of active lactation; known history of allergy or
        hypersensitivity to dantrolene; known history of seizure disorders or epilepsy; current or
        prior use (within the past 2 weeks) of calcium channel blockers.

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