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NCT02714036 · ClinicalTrials.gov registry record · Phase 1
A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)
A Phase 1 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT02714036: Completed Phase 1 study, sponsored by MediciNova.
NCT02714036 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02714036, a Phase 1 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be eligible subjects must meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability, blood, neuro-imaging biomarkers, and clinical outcomes will be collected on all subjects. Subjects will receive study drug for 36 weeks. The study will consist of a Screening Phase (up to 6 weeks), an Open-Label Treatment Phase (36 weeks) and an Off-Treatment Follow-up Phase (4 Weeks). Number of Subjects (Planned): Approximately 45 subjects are planned to be screened with the goal of enrolling 35 subjects.
Primary Outcome
Glial activation will be estimated in eligible participants in the Regular arm by combined magnetic resonance positron emission tomography (MR-PET) using the \[11C\]-PBR28 radioligand. \[11C\]-PBR28 uptake is quantified as the ratio of the standardized uptake value (SUVR). An independent neuroimaging rater blinded to the clinical data will assess for quality control of the PBR28-PET images and SUVR. The primary analysis will be performed on the modified Intent-to-Treat (mITT) population. The med
Interventions
- DRUG Ibudilast
- DRUG ibudilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-05-06 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 1 |
What the finished NCT02714036 record still lists
NCT02714036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibudilast is the first listed.
NCT02714036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02714036 about?
NCT02714036 is a clinical study titled "A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)". This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be eligible subjects must meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability, blood, neuro-imaging biomarkers, an...
What is the current status of trial NCT02714036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2016-05-06. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02714036?
The interventions under investigation include: Ibudilast (DRUG), ibudilast (DRUG).
Who is sponsoring clinical trial NCT02714036?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02714036's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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