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

NCT03189433 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: EGL-4104-C-1702
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Toxicity Psychotropic Agents Psychostimulants

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Achieved a Logistic Organ Dysfuction System (LODS) Total Score Less Than or Equal to 5

  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.

  At or prior to 60 minutes post-randomization

Secondary Outcomes (1)

• Proportion of Subjects Who Achieved a LODS Total Score Less Than or Equal to 5 at Other Planned Time Points.

  Up to 6 hours post-dose.

Study Arms (2)

Ryanodex + Standard of Care

ACTIVE COMPARATOR

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

Standard of Care only (SOC)

NO INTERVENTION

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\].

Interventions

Ryanodex (dantrolene sodium) for injectable suspension DRUG

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.

Ryanodex + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Eagle Pharmaceuticals, Inc.: lead

Study Sites (1)

CrowdRx Medical Office- Moonrise Festival

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Interventions

Dantrolene

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eagle Pharmaceuticals, Inc.

medinfo@eagleus.com

201-326-5300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: August 12, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)