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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: Clinical Trial Phase 2 study, sponsored by Eagle Pharmaceuticals.
NCT03189433 is a Phase 2 study that was terminated before completion, run by Eagle Pharmaceuticals. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT03189433 stopped before completion
NCT03189433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Ryanodex (dantrolene sodium) for injectable suspension is the first listed.
NCT03189433 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03189433's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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