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NCT02398461 · ClinicalTrials.gov registry record · Phase 1
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
A Phase 1 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02398461: Completed Phase 1 study, sponsored by Acorda Therapeutics.
NCT02398461 is a Phase 1 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02398461, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
Primary Outcome
Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).
Interventions
- DRUG Placebo
- DRUG rHIgM22
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-09-21 |
| Phase | Phase 1 |
What the finished NCT02398461 record still lists
NCT02398461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02398461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02398461 about?
NCT02398461 is a clinical study titled "An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse". This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
What is the current status of trial NCT02398461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-04. Estimated completion is 2017-09-21.
What interventions are being tested in trial NCT02398461?
The interventions under investigation include: Placebo (DRUG), rHIgM22 (DRUG).
Who is sponsoring clinical trial NCT02398461?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02398461's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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