CompletedPhase 3Relapsing and progressiveNCT02290444

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Corticotropin

    Melanocortin receptor 2 agonist

Results by group

Change From Baseline on the Symbol Digit Modalities Test (SDMT)

Day 0 and Day 90

GroupValueIntervalNumber analysed
Cognitively Relapsing Patients44.6 Total Correct13.9 (Standard Deviation)25
Stable Multiple Sclerosis Patients58.5 Total Correct13.9 (Standard Deviation)25

Cognitively Relapsing Patients

44.6

Stable Multiple Sclerosis Patients

58.5

Timed 25-foot Walk

Day 0 and Day 90

GroupValueIntervalNumber analysed
Cognitively Relapsing Patients6.7 Seconds3.2 (Standard Deviation)25
Stable Multiple Sclerosis Patients5.3 Seconds1.2 (Standard Deviation)25

Cognitively Relapsing Patients

6.7

Stable Multiple Sclerosis Patients

5.3

Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)

Day 0 and Day 90

GroupValueIntervalNumber analysed
Cognitively Relapsing Patients40.1 Total Correct12.2 (Standard Deviation)25
Stable Multiple Sclerosis Patients47.0 Total Correct14.3 (Standard Deviation)25

Cognitively Relapsing Patients

40.1

Stable Multiple Sclerosis Patients

47

Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)

Day 0 and Day 90

GroupValueIntervalNumber analysed
Cognitively Relapsing Patients22.0 Total Learning Score8.9 (Standard Deviation)25
Stable Multiple Sclerosis Patients22.5 Total Learning Score7.9 (Standard Deviation)25

Cognitively Relapsing Patients

22

Stable Multiple Sclerosis Patients

22.5

Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)

Day 0 and Day 90

GroupValueIntervalNumber analysed
Cognitively Relapsing Patients46.6 Total Learning Score14.1 (Standard Deviation)25
Stable Multiple Sclerosis Patients51.2 Total Learning Score11.8 (Standard Deviation)25

Cognitively Relapsing Patients

46.6

Stable Multiple Sclerosis Patients

51.2

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Cognitively Relapsing Patients250 (0.0%)0
Stable Multiple Sclerosis Patients250 (0.0%)0

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 From Baseline on the Symbol Digit Modalities Test (SDMT)

    Day 0 and Day 90

    Thinking and memory
  • Timed 25-foot Walk

    Day 0 and Day 90

    Disability progressionWalking and mobility
  • Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)

    Day 0 and Day 90

    Thinking and memory
  • Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)

    Day 0 and Day 90

    Thinking and memory
  • Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)

    Day 0 and Day 90

    Thinking and memory

Other measures (4)

  • Change From Baseline on the Expanded Disability Status Scale (EDSS).

    Day 0 and Day 90

    Disability progression
  • Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)

    Day 0 and Day 90

    Thinking and memory
  • Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)

    Day 0 and Day 90

    Mood and sleep
  • Change From Baseline on the Fatigue Severity Scale (FSS)

    Day 0 and Day 90

    Fatigue

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: 1. Males/Females between 18 and 65 years of age who are capable of understanding and complying with the protocol (ie. have completed at least a 9th grade education and are fluent English). 2. Have a diagnosis of Relapsing Remitting MS (RRMS) or early Secondary Progressive MS (SPMS) as per revised McDonald's Criteria. 3. Have an Expanded Disability Severity Scale (EDSS) of ≤ 7.0. 4. Have had valid neuropsychological testing (NP) within the past 4 years 5. Experiencing an acute cognitive relapse identified by a clinical care provider as a.) a cognitive symptom of recent origin developing over 48 hours, or b.) supratentorial GAD enhancing lesions on MRI with confirmed cognitive decline. * Confirmation of cognitive decline will be obtained by administering the Symbol Digit Modalities Test (SDMT) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). Participants qualify if a raw point change on the SDMT greater than or equal to -3 points is detected. 6. Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction. 7. Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care. Exclusion Criteria: 1. Are found to have evidence on MRI of new lesions in the brainstem, spinal cord, or optic nerve. 2. Have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve. 3. Have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease. 4. Have evidence of current major depression as determined by a positive Beck Depression Inventory-Fast Screen (BDI-FS) and clinician interview. 5. Patients with changes to medications known to influence cognition (narcotics, stimulants, etc.) or disease modifying therapy within one month of study initiation (or within a time frame deemed high risk by treating physician) will be excluded. 6. Are taking any medication, or have any medical condition contraindicated with Acthar. 7. Presence of current infections as determined by clinician interview. 8. Are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.

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

About this trial

In the sponsor's words

The purpose of this study is to evaluate the effect of a medication called Acthar on recovery from multiple sclerosis-related relapses that impact cognition.

Papers

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Related trials

History

    1. Started

      Aug 2013

    2. Main results due

      Nov 2018

    3. Finished

      Nov 2018

    4. Results posted

      Apr 2020

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