Trial · NCT02513095
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
NCT02513095, Phase 2, Completed, Eagle Pharmaceuticals, Inc.; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS). Trials, record NCT02513095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02513095
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
- NCT number
- NCT02513095
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Conditions
- Heat Stroke
- Interventions
- Dantrolene sodium for injectable suspension
- First posted
- 2015-07-31
- Last updated
- 2021-06-29
- Results first posted
- 2017-05-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | 90 minutes post-randomization | Number of subjects achieving a Glasgow Coma Scale(GCS) ≥ 13 at or prior to 90 minutes post-randomization. The Glasgow Coma Scale (GCS) is a reliable and objective way of recording the initial and subsequent level of consciousness in a person after a brain injury. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score\*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe. \*Subscales: Eyes Response -Spontaneous=4; To sound =3; To Pressure=2; None=1; not tested. Verbal Response- Oriented=5; Confused=4; Words=3; Sounds=2; None-1; Not tested. Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | 90 minutes post-randomization | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | Ryanodex Plus Standard of Care | 5 | Participants | ||
| Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | Standard of Care | 2 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active | 17 | |
| Overall Study | STARTED | Control | 17 | |
| Overall Study | Treatment Phase - Up to 120 Minutes | Active | 17 | |
| Overall Study | Treatment Phase - Up to 120 Minutes | Control | 17 | |
| Overall Study | COMPLETED | Active | 17 | |
| Overall Study | COMPLETED | Control | 17 | |
| Overall Study | NOT COMPLETED | Active | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events58
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 | Dysphagia | Gastrointestinal disorders | Ryanodex | 1 | 17 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Standard of Care Only (SOC) | 0 | 17 | 0 |
| other | Nausea | Gastrointestinal disorders | Ryanodex | 1 | 17 | 1 |
| other | Nausea | Gastrointestinal disorders | Standard of Care Only (SOC) | 0 | 17 | 0 |
| other | Vomiting | Gastrointestinal disorders | Ryanodex | 1 | 17 | 1 |
| other | Vomiting | Gastrointestinal disorders | Standard of Care Only (SOC) | 0 | 17 | 0 |
| other | Chills | General disorders | Ryanodex | 0 | 17 | 0 |
| other | Chills | General disorders | Standard of Care Only (SOC) | 3 | 17 | 3 |
| other | Alanine Aminotransferase Increased | Investigations | Ryanodex | 1 | 17 | 1 |
| other | Alanine Aminotransferase Increased | Investigations | Standard of Care Only (SOC) | 0 | 17 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ryanodex | 1 | 17 |
| Total, all-cause mortality | Standard of Care Only (SOC) | 0 | 17 |
| Total, other adverse events | Ryanodex | 17 | 17 |
| Total, other adverse events | Standard of Care Only (SOC) | 17 | 17 |
| Total, serious adverse events | Ryanodex | 4 | 17 |
| Total, serious adverse events | Standard of Care Only (SOC) | 3 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 vs Standard of Care Only (SOC): deaths from any cause | Trial comparisons |
| Ryanodex Plus Standard of Care vs Standard of Care: Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | Trial comparisons |
| Ryanodex 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/NCT02513095
GET https://conductscience.org/api/trials/v1/NCT02513095/events?page=2