Effects of Acthar on Recovery From Cognitive Relapses in MS
NCT ID: NCT02290444
Last Updated: 2020-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2013-08-31
2018-11-01
Brief Summary
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Detailed Description
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The objectives of the study are:
1. To replicate prior findings with steroid therapy for MS patients for cognitive relapses, using instead Acthar Gel as the treating agent. The investigators will determine if the decrease on cognitive endpoints at the time of relapse exceeds that of stable MS controls.
2. To compare the effects above to a previously acquired dataset of relapsing patients treated with steroids. This is a quasi-experimental design in so far as the steroid treated group data were previously acquired in a separate study.
The primary hypothesis of the study is that, due to the enhanced melanocortin response in Acthar the recovery from cognitive changes occurring during cognitively focused relapse will be significant compared to stable MS patients matched on age, time since testing, and cognitive performance on the SDMT.
Target enrollment for the Acthar treatment group will be 30 MS patients under care at the Jacobs Neurological Institute with existing neuropsychological baseline in the past four years in whom a cognitive relapse or new supratentorial GAD enhancing lesion(s) on MRI have been identified. Cognitive relapse will be identified based on clinical presentation of acute worsening of cognitive symptoms in the domains of processing speed, concentration, episodic memory, working memory, and/or fatigue. Patients whose clinical MRI indicate new active GAD enhancing lesions will be screened for the presence of self-perceived cognitive decline, without new physical symptoms. Thirty (30) clinically stable MS patients matched on age, time since testing, and cognitive performance on the SDMT will be recruited from the pool of patients with existing cognitive baselines.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cognitively Relapsing Patients
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone
Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
Stable Multiple Sclerosis Patients
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
No interventions assigned to this group
Interventions
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Adrenocorticotropic Hormone
Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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.
18 Years
65 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Ralph H.B. Benedict
Professor of Neurology and Psychiatry
Principal Investigators
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Ralph HB Benedict, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Buffalo-State University of New York
Locations
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University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital
Buffalo, New York, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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465028
Identifier Type: -
Identifier Source: org_study_id
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