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Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)

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ClinicalTrials.gov Identifier: NCT03189433
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eagle Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Drug Toxicity Psychotropic Agents Psychostimulants Drug: Ryanodex (dantrolene sodium) for injectable suspension Phase 2

Detailed Description:
This study will be conducted at pre-hospital emergency care (PHEC) facilities. The PHECs are medical units that are fully equipped and staffed to provide adequate emergency medical care to patients with PDIT. The study is designed to evaluate the safety and efficacy of Ryanodex in an on0site pre-hospital emergency setting where subjects are anticipated to be treated over a short period of time and then transferred to another medical facility or released. After screening and diagnosis of PDIT, SOC treatment will be initiated. Subjects eligible for the study will be randomized to either receive SOC + Ryanodex or to receive SOC only. Study subjects are expected to remain at the study site for a maximum of 6 hours post-baseline.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ryanodex (dantrolene sodium) for injectable suspension
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.

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].



Primary Outcome Measures :
  1. Proportion of subjects who achieved a LODS total score less than or equal to 5 [ Time Frame: At or prior to 60 minutes post-randomization ]
    Logistic Organ Dysfunction System (LODS) score (measure/scoring of 1-3 specific parameters in 6 organ systems; neurologic, cardiologic, renal, pulmonary, hematologic, and hepatic)


Secondary Outcome Measures :
  1. 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. ]
    Proportion of subjects who achieved a LODS total score less than or equal to 5 at other planned time points.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189433


Locations
United States, Maryland
CrowdRx Medical Office- Moonrise Festival
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Eagle Pharmaceuticals, Inc.

Responsible Party: Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03189433     History of Changes
Other Study ID Numbers: EGL-4104-C-1702
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Dantrolene
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents