Multiple Sclerosis (MS) Clinical Trial
Official title:
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
This pilot study is designed as a prospective cohort study to determine whether standard subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5 days in the treatment of relapses or attacks in multiple sclerosis (MS).
Status | Completed |
Enrollment | 25 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Adult male or female subjects with MS having a relapse (attack) or exacerbation of MS. Acute symptomatic exacerbation of MS present for > 24 hours and < 14 days at screening with new or worsening symptoms, and with signs referable to the symptoms in the absence of a fever or active infection. 2. Diagnosis of a relapsing forms of multiple sclerosis before randomization as determined by Poser or McDonald Criteria (standard MS diagnostic criteria). 3. Expanded disability status scale (EDDS) between 2 and 6.5, inclusive at entry. 4. Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction. 5. New objective clinical finding other than the sensory exacerbation or the bowel/bladder signs alone. Sensory deficits alone will not qualify except for optic neuritis. 6. Subjects may continue on their current immunomodulation therapy such as interferons, glatiramer acetate, gilenya or natalizumab. 7. Identified patients must be between the ages of 18 and 55 years, inclusive. 8. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Subjects who are pregnant, or nursing. 2. Any patients treated with systemic corticosteroid use within one month of the index episode at screening. 3. Prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, Cellcept, IVIg) or plasmapheresis. 4. Unable to perform timed 25 foot walk (ambulation Index), 9 HPT (9 hole peg test), PASAT (Paced Auditory Serial Addition Test) 3. 5. Peripheral or cranial neuropathy as sole problem of acute episode. 6. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. 7. History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy. 8. Subjects with clinical diagnosis of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins of porcine origin. 9. Primary Progressive Multiple Sclerosis (PPMS) (MS without attacks). - |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas-Houston Neurology Clinic | Houston | Texas |
United States | The MS Center at the Neurology Center in Southern California | Oceanside | California |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of MRI brain activity before and after ACTH treatment between the two treatment groups | Brain MRI scan ± Gd will be performed on subjects at entry, day 28 and day 90. Qualitative assessments of changes in numbers of Gd+ lesions from entry to exit will be assessed. | 28 Days (with 90 day follow-up) | No |
Other | Comparison of immune changes before and after ACTH treatment between the two treatment groups | Peripheral mononuclear cells will be collected from patients at baseline,14 and 28 days post treatment and cytokine responses will be examined using a customized Human Cytokine Inflammatory Antibody Array including Th1-like (IL-2, IL-17, IFN-g, TNF-a, IL-1b), Th2-like cytokines (IL-4, IL-10, IL-13) | 28 Days (with 90 day follow-up) | No |
Primary | Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | To determine whether a standard 14 day course of SQ 80 IU ACTHar Gel therapy might be superior (in twice as many patients) to treatment with 5 day SQ regimen for ACTHar Gel as determined by EDSS mean recovery from Day 0 (time of steroid therapy initiation) to Day 28 (and day 90). | 28 Days (with 90 day follow-up) | No |
Secondary | Comparison of ambulation between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups | The ambulation index (AI) will be used for patients with long track (pyramidal) relapses, i.e. relapses with leg involvement. This is a standardized rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. | 28 Days (with 90 day follow-up) | No |
Secondary | Comparison of upper extremity function between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups | The nine-hole peg test (9HPT) will be used for patients with arm involvement during relapses. The 9-HPT is a brief, standardized, quantitative test of upper extremity function. This is a timed test to determine how long it takes the patient to quickly place nine pegs (one at a time) in a wooden box with 9 empty holes, and them remove them again (one at a time) as quickly as possible. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. | 28 day (with 90 follow up) | No |
Secondary | Comparison of subjective impressions of effectiveness between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | The patient global impression of change (PGI-Change) will be used in patients to compare subjective impressions of effectiveness between treatment groups | 28 day (with 90 day follow up) | No |
Secondary | Compare visual function between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | Visual function, as measured by low contrast Sloan sensitivity testing (LCSST) will be performed on each patient at baseline and at the end of treatment | 28 day (with 90 day follow up) | No |
Secondary | Comparison of cognitive function between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | In patients who report cognitive deficits during relapse, the paced auditory serial addition test (PASAT-3) will be used to assess and measure capacity and rate of information processing, and sustained and divided attention. This is a common neuropsychological test used in MS trials that involves working memory, attention and arithmetic capabilities. Patients will hear a series of recorded single-digit numbers at a rate of 1 per 3 seconds, and asked to add the number they just heard with the number they heard before. | 28 day (with 90 day follow up) | No |
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