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NCT02446886 · ClinicalTrials.gov registry record · Phase 4

Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS

A Phase 4 study, sponsored by Weill Medical College of Cornell University.

Terminated
Registry status
Phase 4
Development phase
15
Enrollment target

NCT02446886: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.

NCT02446886 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02446886, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.

TERMINATED
Registry status
Phase 4
Development phase
15 participants
Enrollment target

Study Summary

The primary objective of this study is to determine if monthly pulse doses of a three-day course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course of treatment. The main secondary objective is to utilize every three month MWF measurements to determine the peak time of remyelination in new multiple sclerosis lesions when followed over the course of 12 months.

Primary Outcome

Primary outcome: The absolute change in lesion MWF (over our test-retest variability) between baseline and one year MRI's will be calculated and compared between treatment groups. Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MW

Interventions

  • DRUG Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2016-06
Est. Completion 2020-06
Phase Phase 4

Why NCT02446886 stopped before completion

NCT02446886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®) is the first listed.

NCT02446886 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02446886 about?

NCT02446886 is a clinical study titled "Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS". The primary objective of this study is to determine if monthly pulse doses of a three-day course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course of treatment. The main se...

What is the current status of trial NCT02446886?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2016-06. Estimated completion is 2020-06.

What interventions are being tested in trial NCT02446886?

The interventions under investigation include: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®) (DRUG).

Who is sponsoring clinical trial NCT02446886?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02446886's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT02446886, the US trial registry maintained by the National Library of Medicine. NCT02446886 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.