Trial · NCT02238626
Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT02238626, Phase 2, Completed, MediciNova; results first posted 2021-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT02238626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02238626
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT02238626
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- MediciNova
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Placebo (for MN-166), MN-166, riluzole
- First posted
- 2014-09-12
- Last updated
- 2021-11-05
- Results first posted
- 2021-11-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | 6 months | Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs and Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations. |
| Secondary | Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | 6 months | Functional activity as assessed by the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised from baseline visit to Month 6. The best possible score is 48; the worst possible score is 0. Typically, ALS scores decline. In this outcome, the change in score will be a negative value, e.g., -4, -8, etc. The higher negative value indicates greater decline in functional activity (change in score -8 is worse than change in score -4). |
| Secondary | Respiratory Function | 6 months | Change in respiratory function (breathing capacity) from baseline to Month 6, as measured by slow vital capacity, in which the patient breathes into a spirometer slowly until the lungs are cleared of air. SVC is measured in liters (L). The greater the mean change from baseline to 6 months, the worse the outcome. For example, -10 is worse than -6. |
| Secondary | Muscle Strength | 6 months | Muscle strength measured by manual muscle testing (MMT) and instrumented hand-held dynamometry. Maximum muscle strength is assessed by measuring the best of 2 handgrips represented as kilograms (kg). The greater the change from baseline to month 6, the worse off the subject is. For example, a change of -0.50 is worse than -0.40. |
| Secondary | Use of Non-invasive Ventilation | 6 months | Non-invasive ventilation (NIV) utilization measured by clinically indicated prescription for NIV intervention and time to clinically indicated prescription for NIV intervention in each group (for early ALS subjects only). This is intended to count the number of subjects who had to go on non-invasive ventilation, as prescribed by the Principal Investigator, during study participation. |
| Secondary | The Mean Change in Baseline to Month 6 in Quality of Life as Measured by the Amyotrophic Lateral Sclerosis Assessment Questionnaire - 5 | 6 months | A patient self-reported questionnaire specifically designed to measure 5 areas of health: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional functioning. The ALSAQ-5 is brief and easy to complete questionnaire and has undergone rigorous testing for validity, reliability, and sensitivity to change and has been shown to be a robust tool for assessing ALS. The lowest possible score is 0 and the highest possible score is 20. The greater the mean decrease from baseline to Month 6, the group was considered worse off. For example, -2 is worse than -1. The greater the mean increase from baseline to Month 6, the group was considered improved. For example, 2 is better than 1. |
| Secondary | Clinical Global Impression of Change (CGIC) | 6 months | A scale used to provide a global rating of illness severity, improvement, and response to treatment. It is a 3-item observer rating scale and uses a 7-point rating scale. The scale was rated relative to the previous standard of care visit prior to randomization for entry, i.e., -3 much much much worse, -2 much much worse, - 1 much worse, 0 no change, +1 much better, +2 much much better, +3 much, much, much better. Ratings were provided by the Investigator. The greater the mean decrease from baseline to Month 6, the group was considered worse off. For example, -2 is worse than -1. The greater the mean increase from baseline to Month 6, the group was considered improved. For example, 2 is better than 1. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | 6 months | Safety analysis population included all randomized subjects who received at least one dose of study drug and had at least one post-dose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | 6 months | Safety Population | score on a scale | MEAN |
| SECONDARY | Respiratory Function | 6 months | Subjects who completed Month 6 (double-blind treatment phase) | Liters | MEAN |
| SECONDARY | Muscle Strength | 6 months | Subjects who completed Month 6 (double-blind treatment phase) | weight (kg) | MEAN |
| SECONDARY | Use of Non-invasive Ventilation | 6 months | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Mean Change in Baseline to Month 6 in Quality of Life as Measured by the Amyotrophic Lateral Sclerosis Assessment Questionnaire - 5 | 6 months | Full analysis set | score on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Change (CGIC) | 6 months | Full analysis set | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | Placebo (for MN-166) (Early ALS Cohort) | 17 | Participants | ||
| Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | MN-166 | 34 | Participants | ||
| Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | Placebo (for MN-166) (Advanced ALS Cohort) | 8 | Participants | ||
| Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS | MN-166 (Advanced ALS Cohort) | 11 | Participants | ||
| Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | Placebo (for MN-166) (Early ALS Cohort) | -3.8 | Standard Deviation 3.91 | score on a scale | |
| Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | MN-166 (Early ALS Cohort) | -4.5 | Standard Deviation 5.1 | score on a scale | |
| Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | Placebo (for MN-166) (Advanced ALS Cohort) | -2.2 | Standard Deviation 2.56 | score on a scale | |
| Mean Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Total Score From Baseline to Month 6 | MN-166 (Advanced ALS Cohort) | -4.8 | Standard Deviation 4.92 | score on a scale | |
| Respiratory Function | Placebo (for MN-166) Early ALS Cohort | -6.1 | Standard Deviation 9.33 | Liters | |
| Respiratory Function | MN-166 (Early ALS Cohort) | -10.1 | Standard Deviation 9.89 | Liters |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (for MN-166) (Early ALS Cohort) | 17 | |
| Overall Study | STARTED | MN-166 (Early ALS Cohort) | 34 | |
| Overall Study | STARTED | Placebo (Advanced ALS Cohort) | 8 | |
| Overall Study | STARTED | MN-166 (Advanced ALS Cohort) | 11 | |
| Overall Study | COMPLETED | Placebo (for MN-166) (Early ALS Cohort) | 12 | |
| Overall Study | COMPLETED | MN-166 (Early ALS Cohort) | 20 | |
| Overall Study | COMPLETED | Placebo (Advanced ALS Cohort) | 5 | |
| Overall Study | COMPLETED | MN-166 (Advanced ALS Cohort) | 4 | |
| Overall Study | NOT COMPLETED | Placebo (for MN-166) (Early ALS Cohort) | 5 | |
| Overall Study | NOT COMPLETED | MN-166 (Early ALS Cohort) | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events124
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 | muscle weakness | Musculoskeletal and connective tissue disorders | Placebo (for MN-166) (Early ALS Cohort) | 9 | 17 | 9 |
| other | muscle weakness | Musculoskeletal and connective tissue disorders | MN-166 (Early ALS Cohort) | 18 | 34 | 18 |
| other | muscle weakness | Musculoskeletal and connective tissue disorders | Placebo (for MN-166) (Advanced ALS Cohort) | 1 | 8 | 1 |
| other | muscle weakness | Musculoskeletal and connective tissue disorders | MN-166 (Advanced ALS Cohort) | 4 | 11 | 4 |
| other | Fall | Injury, poisoning and procedural complications | Placebo (for MN-166) (Early ALS Cohort) | 8 | 17 | 8 |
| other | Fall | Injury, poisoning and procedural complications | MN-166 (Early ALS Cohort) | 14 | 34 | 14 |
| other | Fall | Injury, poisoning and procedural complications | Placebo (for MN-166) (Advanced ALS Cohort) | 1 | 8 | 1 |
| other | Fall | Injury, poisoning and procedural complications | MN-166 (Advanced ALS Cohort) | 5 | 11 | 5 |
| other | Fatigue | General disorders | Placebo (for MN-166) (Early ALS Cohort) | 4 | 17 | 4 |
| other | Fatigue | General disorders | MN-166 (Early ALS Cohort) | 12 | 34 | 12 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (for MN-166) (Early ALS Cohort) | 0 | 17 |
| Total, all-cause mortality | MN-166 (Early ALS Cohort) | 1 | 34 |
| Total, all-cause mortality | Placebo (for MN-166) (Advanced ALS Cohort) | 1 | 8 |
| Total, all-cause mortality | MN-166 (Advanced ALS Cohort) | 1 | 11 |
| Total, other adverse events | Placebo (for MN-166) (Early ALS Cohort) | 17 | 17 |
| Total, other adverse events | MN-166 (Early ALS Cohort) | 34 | 34 |
| Total, other adverse events | Placebo (for MN-166) (Advanced ALS Cohort) | 8 | 8 |
| Total, other adverse events | MN-166 (Advanced ALS Cohort) | 11 | 11 |
| Total, serious adverse events | Placebo (for MN-166) (Early ALS Cohort) | 1 | 17 |
| Total, serious adverse events | MN-166 (Early ALS Cohort) | 5 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MN-166 (Early ALS Cohort) vs Placebo (for MN-166) (Early ALS Cohort): Use of Non-invasive Ventilation |
Source 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/NCT02238626
GET https://conductscience.org/api/trials/v1/NCT02238626/results?page=2