Trial · NCT03600376
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
NCT03600376, Phase 3, Completed, Eagle Pharmaceuticals, Inc.; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS. Trials, record NCT03600376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03600376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
- NCT number
- NCT03600376
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 17 participants, actual
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Conditions
- Exertional Heat Stroke
- Interventions
- Ryanodex and Standard of Care, Standard of Care
- First posted
- 2018-07-26
- Last updated
- 2021-05-19
- Results first posted
- 2021-04-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | 90 minutes post-randomization | The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst). |
| Secondary | Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Treatment duration, up to 6 hours | The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | 90 minutes post-randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Treatment duration, up to 6 hours | the outcome measure data table below is a summary of results showing the cumulative proportion of subjects achieving GCS score ≥13 post-randomization at all planned time points. Data is cumulative therefore the counts in the categories below will not add up to the Number Analyzed.~score ≥ 13 post-randomization at all planned time points in the study is shown | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | Ryanodex and Standard of Care | 4 | Participants | ||
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | Standard of Care Only (SOC) | 2 | Participants | ||
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Ryanodex and Standard of Care | Pts. achieving GCS score ≥ 13 at 15 min post-randomization | 1 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Standard of Care Only (SOC) | Pts. achieving GCS score ≥ 13 at 15 min post-randomization | 0 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Ryanodex and Standard of Care | Pts. achieving GCS score ≥ 13 at 30 min. post-randomization | 1 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Standard of Care Only (SOC) | Pts. achieving GCS score ≥ 13 at 30 min. post-randomization | 0 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Ryanodex and Standard of Care | Pts. achieving GCS score ≥ 13 after 45 min. post-randomization | 1 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Standard of Care Only (SOC) | Pts. achieving GCS score ≥ 13 after 45 min. post-randomization | 0 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Ryanodex and Standard of Care | Pts. achieving GCS score ≥ 13 after 60 min. post-randomization | 2 | Participants | |
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration] | Standard of Care Only (SOC) | Pts. achieving GCS score ≥ 13 after 60 min. post-randomization | 1 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ryanodex and Standard of Care | 9 | |
| Overall Study | STARTED | Standard of Care Only (SOC) | 8 | |
| Overall Study | COMPLETED | Ryanodex and Standard of Care | 7 | |
| Overall Study | COMPLETED | Standard of Care Only (SOC) | 2 | |
| Overall Study | NOT COMPLETED | Ryanodex and Standard of Care | 2 | |
| Overall Study | NOT COMPLETED | Standard of Care Only (SOC) | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Ryanodex and Standard of Care | 1 | 9 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Standard of Care Only (SOC) | 0 | 8 | 0 |
| other | Nausea | Gastrointestinal disorders | Ryanodex and Standard of Care | 1 | 9 | 1 |
| other | Nausea | Gastrointestinal disorders | Standard of Care Only (SOC) | 0 | 8 | 0 |
| other | Coma Scale Abnormal | Investigations | Ryanodex and Standard of Care | 1 | 9 | 1 |
| other | Coma Scale Abnormal | Investigations | Standard of Care Only (SOC) | 0 | 8 | 0 |
| other | Haemoglobin decreased | Investigations | Ryanodex and Standard of Care | 1 | 9 | 1 |
| other | Haemoglobin decreased | Investigations | Standard of Care Only (SOC) | 0 | 8 | 0 |
| other | Acidosis | Metabolism and nutrition disorders | Ryanodex and Standard of Care | 1 | 9 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Standard of Care Only (SOC) | 0 | 8 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ryanodex and Standard of Care | 0 | 9 |
| Total, all-cause mortality | Standard of Care Only (SOC) | 0 | 8 |
| Total, other adverse events | Ryanodex and Standard of Care | 7 | 9 |
| Total, other adverse events | Standard of Care Only (SOC) | 5 | 8 |
| Total, serious adverse events | Ryanodex and Standard of Care | 1 | 9 |
| Total, serious adverse events | Standard of Care Only (SOC) | 2 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33848093 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ryanodex and Standard of Care vs Standard of Care Only (SOC): Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | Trial comparisons |
| Ryanodex and Standard of Care vs Standard of Care Only (SOC): deaths from any cause | Trial comparisons |
| Ryanodex and Standard of Care vs Standard of Care Only (SOC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03600376
GET https://conductscience.org/api/trials/v1/NCT03600376/events?page=2