Effects of Acthar on Recovery From Cognitive Relapses in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02290444
• Date of registration: 23/10/2014
• Prospective Registration: No
• Primary sponsor: State University of New York at Buffalo
• Public title: Effects of Acthar on Recovery From Cognitive Relapses in MS
• Scientific title: Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis
• Date of first enrolment: August 2013
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02290444
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Ralph HB Benedict, PhD
• Affiliation: University of Buffalo-State University of New York

Key inclusion & exclusion criteria

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normal medical care, with the understanding that consent may be withdrawn by the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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Adrenocorticotropic Hormone

Primary Outcome(s)

Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) [Time Frame: Day 0 and Day 90]

Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) [Time Frame: Day 0 and Day 90]

Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) [Time Frame: Day 0 and Day 90]

Change From Baseline on the Symbol Digit Modalities Test (SDMT) [Time Frame: Day 0 and Day 90]

Timed 25-foot Walk [Time Frame: Day 0 and Day 90]

Secondary Outcome(s)

Change From Baseline on the Expanded Disability Status Scale (EDSS). [Time Frame: Day 0 and Day 90]

Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) [Time Frame: Day 0 and Day 90]

Change From Baseline on the Fatigue Severity Scale (FSS) [Time Frame: Day 0 and Day 90]

Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) [Time Frame: Day 0 and Day 90]

Secondary ID(s)

465028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02290444