Effects of Acthar on Recovery From Cognitive Relapses in MS
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|ClinicalTrials.gov Identifier: NCT02290444|
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2014
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Adrenocorticotropic Hormone||Phase 3|
This is a prospective, open-label study of Acthar administered as treatment for an acute cognitive relapse. Primary and secondary endpoints will be collected prior to Acthar administration and at 3-month follow-up. Comparison will be made to a stable MS control group.
The objectives of the study are:
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 1, 2017|
|Estimated Study Completion Date :||December 1, 2017|
Experimental: 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.
Drug: 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 Name: Acthar gel
No Intervention: 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.
- Change from baseline on the Symbol Digit Modalities Test (SDMT) [ Time Frame: Day 0 and Day 90 ]A measure of visual processing speed and working memory
- Change from baseline on the Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: Day 0 and Day 90 ]An MS-specific composite measure of functional status incorporating aspects of cognition, walking speed and manual dexterity.
- Change from baseline on the Paced Auditory Serial Addition Test (PASAT) [ Time Frame: Day 0 and Day 90 ]A measure of auditory processing speed and working memory
- Change from baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Day 0 and Day 90 ]A measure of visual/spatial memory
- Change from baseline on the California Verbal Learning Test, second edition (CVLT-II) [ Time Frame: Day 0 and Day 90 ]A measure of auditory/verbal episodic memory
- Change from baseline on the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 0 and Day 90 ]A clinician assigned measure of disability specific to MS
- Change from baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) [ Time Frame: Day 0 and Day 90 ]A self and informant rating measure of perceived cognitive problems
- Change from baseline on the Multiple Sclerosis Impact Scale (MSIS) [ Time Frame: Day 0 and Day 90 ]A self-report instrument measuring the physical and psychological impact of multiple sclerosis
- Change from baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) [ Time Frame: Day 0 and Day 90 ]A self-report, multiple choice inventory of depression
- Change from baseline on the Fatigue Severity Scale (FSS) [ Time Frame: Day 0 and Day 90 ]A self-report measure of fatigue
- Incidence of Adverse Events [ Time Frame: Up to 3 months ]The number of patients reporting adverse events over the course of the study
- Change from baseline in concurrent medications [ Time Frame: Up to 3 months ]Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290444
|United States, New York|
|University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Ralph HB Benedict, PhD||University of Buffalo-State University of New York|