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NCT03189433 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
A Phase 2 study, sponsored by Eagle Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03189433 is a Phase 2 study that was terminated before completion, run by Eagle Pharmaceuticals. The registered enrollment target is 2 participants.
The verdict
NCT03189433, a Phase 2 study, was terminated before completion, sponsored by Eagle Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ryanodex (dantrolene sodium) for injectable suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-08-12 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03189433
The ClinicalTrials.gov registry entry for NCT03189433 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eagle Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ryanodex (dantrolene sodium) for injectable suspension is the first listed.
NCT03189433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03189433 about?
NCT03189433 is a clinical study titled "Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)". 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";...
What is the current status of trial NCT03189433?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2017-08-12. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03189433?
The interventions under investigation include: Ryanodex (dantrolene sodium) for injectable suspension (DRUG).
Who is sponsoring clinical trial NCT03189433?
This trial is sponsored by Eagle Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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