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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 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02714036
The ClinicalTrials.gov registry entry for NCT02714036 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediciNova, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ibudilast is the first listed.
NCT02714036 reports 0 study locations.
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.
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