- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189433
Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Phase 2, Multiple-Site, Open-Label, Randomized, 2-Group, Parallel Study to Assess the Efficacy and Safety of Ryanodex(R) (EGL-4101)as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21215
- CrowdRx Medical Office- Moonrise Festival
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 After enrollment, if the pending baseline LODS score turns out to be less than 6, the subject will be withdrawn from the study and replaced); known or suspected us of a psychostimulant drug in the judgment of the Investigator; negative blood pregnancy test for females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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Ryanodex + Standard of Care
Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC).
SOC is defined as efficient body cooling by physical methods and supportive measures [ice packs, evaporative cooling(application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
Administer a single dose of Ryanodex.
If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.
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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.
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NO_INTERVENTION: Standard of Care only (SOC)
Standard of Care is defined as efficient body cooling by physical methods and supportive methods and supportive measures[ice packs, evaporative cooling (application of room temperature water via mist with use of a fan], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities].
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Who Achieved a Logistic Organ Dysfuction System (LODS) Total Score Less Than or Equal to 5
Time Frame: At or prior to 60 minutes post-randomization
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Logistic Organ Dysfunction System (LODS) score (measure/scoring of 1-3 specific parameters in 6 organ systems; neurologic, cardiologic, renal, pulmonary, hematologic, and hepatic).
One to 5 LODS points are assigned to the levels of severity and the resulting LODS scores range can range from 0 to 22 points.
A lower score represents a better outcome; a score of 0 points is a better outcome than a score o 22 points.
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At or prior to 60 minutes post-randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Who Achieved a LODS Total Score Less Than or Equal to 5 at Other Planned Time Points.
Time Frame: Up to 6 hours post-dose.
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Proportion of subjects who achieved a LODS total score less than or equal to 5 at other planned time points.
One to 5 LODS points are assigned to the levels of severity and the resulting LODS scores range can range from 0 to 22 points.
A lower score represents a better outcome.
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Up to 6 hours post-dose.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGL-4104-C-1702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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