Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02238626 · ClinicalTrials.gov registry record · Phase 2
Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT02238626 is a Phase 2 study that has completed, run by MediciNova. The registered enrollment target is 70 participants.
The verdict
NCT02238626, a Phase 2 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS. This study will consist of two treatment arms, MN-166 and matching placebo. Randomization will occur in a 2:1 ratio (MN- 166: placebo). Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months; Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last dose. During treatment phase, subjects return to the clinic at Months 3 and 6 and will be telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new or concomitant medications. All subjects (subjects who complete the Double-blind Phase and subjects who complete the Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately 2 weeks after the last dose of study drug to assess adverse event status and to document concomitant medications. Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. 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.
Interventions
- DRUG MN-166
- DRUG Placebo (for MN-166)
- DRUG riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02238626
The ClinicalTrials.gov registry entry for NCT02238626 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 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 3 interventions - of which MN-166 is the first listed.
NCT02238626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02238626 about?
NCT02238626 is a clinical study titled "Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)". This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS. This study will consist of...
What is the current status of trial NCT02238626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2014-09. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02238626?
The interventions under investigation include: MN-166 (DRUG), Placebo (for MN-166) (DRUG), riluzole (DRUG).
Who is sponsoring clinical trial NCT02238626?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.