Trial · NCT04569084
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
NCT04569084, Phase 3, Terminated, Shionogi; results first posted 2025-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS. Trials, record NCT04569084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04569084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
- NCT number
- NCT04569084
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 384 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- ALS
- Interventions
- MT-1186, Placebo
- First posted
- 2020-09-29
- Last updated
- 2026-07-20
- Other registries' IDs
- eudract:2019-004256-11
- Results first posted
- 2025-03-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CAFS Score at Week 48 | up to 48 Weeks | CAFS ranks patients' clinical outcomes based on survival time and change in the ALSFRS-R score. To calculate a patient's CAFS, each patient is compared individually to all other patients in the study. The summary score for each patient is the sum of the comparisons ( 1, 0, 1) against all other patients. After that, patients' summary scores are ranked. The CAFS rank is 1-383 and a higher CAFS rank indicates a better outcome than does a lower CAFS. Since CAFS were calculated using the imputed ALSFRS-R scores with multiple imputation method, and the maximum varies for each simulation, 383 is the maximum possible value of full range for measure of dispersion. |
| Secondary | Change From Baseline in % Slow Vital Capacity (SVC) at Week 48 | up to 48 Weeks | SVC measurements will be conducted in clinic at around the same time of day where possible with the subject in sitting upright position. Subjects should make at least 3 attempts to generate acceptable and reproducible SVC data. The highest value was selected and recorded. |
| Secondary | Change From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48 | up to 48 Weeks | The ALSAQ-40 is a questionnaire that consists of 40 questions/items with 5 discrete scales: physical mobility, activities of daily living and independence, eating and drinking, communication, emotional reactions, ranging from 0 (best health as assessed by the scale) to 100 (worse health as assessed by the measure). |
| Secondary | Time to Death, Tracheostomy or Permanent Assisted Mechanical Ventilation (≥ 23 Hours/Day) | up to 48 Weeks | |
| Secondary | Time to Death or PAMV (≥ 23 Hours/Day) | up to 48 Weeks | |
| Secondary | Time to Death | up to 48 Weeks |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CAFS Score at Week 48 | up to 48 Weeks | One subject randomized to the On/Off treatment group was excluded from this analysis because the subject did not receive any study treatment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in % Slow Vital Capacity (SVC) at Week 48 | up to 48 Weeks | Those patients reached to Week 48 and conducted SVC assessment. | percentage of SVC | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48 | up to 48 Weeks | Those patients reached to Week 48 and conducted ALSAQ-40 assessment. | Point | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Death, Tracheostomy or Permanent Assisted Mechanical Ventilation (≥ 23 Hours/Day) | up to 48 Weeks | Months | MEAN | |
| SECONDARY | Time to Death or PAMV (≥ 23 Hours/Day) | up to 48 Weeks | Months | MEDIAN | |
| SECONDARY | Time to Death | up to 48 Weeks | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CAFS Score at Week 48 | Edaravone 105 mg (Once Daily) | 187.2 | Full Range 4 to 383 | Units on a scale | |
| CAFS Score at Week 48 | Edaravone 105mg (2 Weeks On/Off ) | 184.2 | Full Range 1 to 383 | Units on a scale | |
| Change From Baseline in % Slow Vital Capacity (SVC) at Week 48 | Edaravone 105 mg (Once Daily) | -26.94 | Standard Error 2.45 | percentage of SVC | |
| Change From Baseline in % Slow Vital Capacity (SVC) at Week 48 | Edaravone 105mg (2 Weeks On/Off ) | -22.15 | Standard Error 2.48 | percentage of SVC | |
| Change From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48 | Edaravone 105 mg (Once Daily) | 2.35 | Standard Error 0.25 | Point | |
| Change From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48 | Edaravone 105mg (2 Weeks On/Off ) | 1.79 | Standard Error 0.25 | Point | |
| Time to Death, Tracheostomy or Permanent Assisted Mechanical Ventilation (≥ 23 Hours/Day) | Edaravone 105 mg (Once Daily) | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Death, Tracheostomy or Permanent Assisted Mechanical Ventilation (≥ 23 Hours/Day) | Edaravone 105mg (2 Weeks On/Off ) | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Death or PAMV (≥ 23 Hours/Day) | Edaravone 105 mg (Once Daily) | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Death or PAMV (≥ 23 Hours/Day) | Edaravone 105mg (2 Weeks On/Off ) | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Edaravone 105 mg (Once Daily) | 192 | |
| Overall Study | STARTED | Edaravone 105mg (2 Weeks On/Off ) | 192 | |
| Overall Study | COMPLETED | Edaravone 105 mg (Once Daily) | 125 | |
| Overall Study | COMPLETED | Edaravone 105mg (2 Weeks On/Off ) | 121 | |
| Overall Study | NOT COMPLETED | Edaravone 105 mg (Once Daily) | 67 | |
| Overall Study | NOT COMPLETED | Edaravone 105mg (2 Weeks On/Off ) | 71 |
Source ClinicalTrials.gov
Adverse events150
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 | Constipation | Gastrointestinal disorders | Edaravone 105 mg (Once Daily) | 24 | 192 | |
| other | Constipation | Gastrointestinal disorders | Edaravone 105mg (2 Weeks On/Off ) | 27 | 191 | |
| other | Diarrhoea | Gastrointestinal disorders | Edaravone 105 mg (Once Daily) | 20 | 192 | |
| other | Diarrhoea | Gastrointestinal disorders | Edaravone 105mg (2 Weeks On/Off ) | 14 | 191 | |
| other | Dysphagia | Gastrointestinal disorders | Edaravone 105 mg (Once Daily) | 11 | 192 | |
| other | Dysphagia | Gastrointestinal disorders | Edaravone 105mg (2 Weeks On/Off ) | 12 | 191 | |
| other | Fatigue | General disorders | Edaravone 105 mg (Once Daily) | 12 | 192 | |
| other | Fatigue | General disorders | Edaravone 105mg (2 Weeks On/Off ) | 10 | 191 | |
| other | Oedema peripheral | General disorders | Edaravone 105 mg (Once Daily) | 10 | 192 | |
| other | Oedema peripheral | General disorders | Edaravone 105mg (2 Weeks On/Off ) | 9 | 191 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edaravone 105 mg (Once Daily) | 9 | 192 |
| Total, all-cause mortality | Edaravone 105mg (2 Weeks On/Off ) | 16 | 192 |
| Total, other adverse events | Edaravone 105 mg (Once Daily) | 118 | 192 |
| Total, other adverse events | Edaravone 105mg (2 Weeks On/Off ) | 131 | 191 |
| Total, serious adverse events | Edaravone 105 mg (Once Daily) | 52 | 192 |
| Total, serious adverse events | Edaravone 105mg (2 Weeks On/Off ) | 55 | 191 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40474686 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Edaravone 105 mg (Once Daily) vs Edaravone 105mg (2 Weeks On/Off ): deaths from any cause | Trial comparisons |
| Edaravone 105 mg (Once Daily) vs Edaravone 105mg (2 Weeks On/Off ): 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/NCT04569084
GET https://conductscience.org/api/trials/v1/NCT04569084/events?page=2