Stopped earlyPhase 4MS (type not specified)NCT03021317

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Terminated early due to lack of resources.

What was tested

Treatment tested

  • Corticotropin

    Melanocortin receptor 2 agonist

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Treated Group000

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in T1 Lesion Relaxation Time

    12 month after the completion of intervention

    MRI lesions

Other measures (1)

  • Change in Immune Subset Expression in CD4+FOXP3 Tregs by Flow Cytometry Post ACTHAR Intervention

    6 month after the completion of intervention

    RelapsesImmune response

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * age > 18 * undergoing a clinical relapse and associated MRI active lesion Exclusion Criteria: * Recent infection, any * use of any glucocorticoid 30 days prior to enrollment * unable to consent

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

ACTHAR is a FDA approved drug for MS relapses. The purpose of the study is to examine the efficacy of this agent in improving relapses as measured by advanced MRI and laboratory techniques: 1. Advanced serial MRI studies on patients during and after an acute MS relapse. MRI will be performed at baseline, 1 month after the 1st dose of ACTHAR, and months 3, 6, and 12. ACTHAR will be administered for 10 days. Patients will start ACTHAR within 48 hours of relapse assessment. 2. Serial immune assays on patients during and after an acute MS relapse. Serum and blood samples with be collected at baseline, last day of ACTHAR (day 10 of therapy), 1 month post 1st dose, and months 3 and 6.

Loading reviews and guidelines…

Related trials

History

    1. Started

      Dec 2016

    2. Main results due

      Oct 2020

    3. Finished

      Oct 2020

    4. Results posted

      May 2024

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error