Phase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified Timepoints
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Central Texas Neurology Consultants
- Enrollment
- 30
- Primary Endpoint
- The primary study objective is to demonstrate whether treatment with alemtuzumab is effective in stabilizing overall neurocognitive functioning in relapsing-remitting multiple sclerosis over time.
- Last Updated
- 15 years ago
Overview
Brief Summary
The main purpose of this research study is to investigate how well a medicine (alemtuzumab) works in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking). This study will include 30 subjects from six research sites.
Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some types of leukemia. As a leukemia treatment, it is given more often and at much higher doses than in this study.
Detailed Description
The current proposal is to conduct a study using a battery of neuropsychological tests capable of detecting the broad range of cognitive difficulties associated with relapsing remitting multiple sclerosis. This study will compare cognitive functioning over time of patients receiving alemtuzumab. The study will also compare the change in cognitive functioning over time to that of relapsing remitting multiple sclerosis patients receiving interferon beta-1a and normal controls enrolled in a parallel study conducted by Wilken et al.To evaluate cognitive effects of alemtuzumab, the investigators will perform neurological exams and brain scans and will administer questionnaires to measure the severity of multiple sclerosis, how well subjects are functioning, how they are feeling, and to find out about what other medical visits subjects may have had during the study. Neurological testing in this study will require the subject to perform relatively simple tasks to evaluate their multiple sclerosis. These tasks include a five hundred meter walk, a timed twenty five foot walk, a nine hole peg test, an eye exam, and a test requiring you to add small numbers in your head quickly. The brain scans will involve Magnetic Resonance Imaging and are painless, except for injection of a contrast agent called gadolinium, which is necessary to detect areas in the brain where their MS may be currently active. Magnetic Resonance Imaging is widely used to diagnose and assess patients with multiple sclerosis. All patients will be required to return to their study site every 3 months for assessments and testing. In addition, safety-related blood tests will be performed at least monthly. If their blood test results become abnormal, they may have to have blood tests taken more frequently, in some cases weekly, until test results improve. Monthly blood tests should be performed at your study site, but if subjects are unable to return to the study site for the blood testing, they may be able to use a local laboratory. Participation in this study should last at least 4 years and possibly longer. Subjects receiving alemtuzumab, will need to have blood tests every month for at least 3 years after your last dose of alemtuzumab. Therefore, you will need to undergo monthly blood tests for a total of about 4 years. If your test results become abnormal, you may have to have blood tests more frequently, in some cases weekly, until your test results improve.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent form (ICF)
- •Age 18 to 55 years old (inclusive) as of the date the ICF is signed
- •Diagnosis of MS per McDonald criteria (2005 update).
- •Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed
- •EDSS score 0.0 to 5.0 (inclusive) at Screening
- •≥ 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF is signed, with ≥ 1 attack in the 12 months prior to the date the ICF is signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other sponsor-approved health-care provider. The objective signs may be identified retrospectively.
- •≥ 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for ≥ 6 months within 10 years of the date the ICF is signed
- •MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist
- •≥ 9 T2 lesions at least 3 mm in any axis
- •a gadolinium-enhancing lesion at least 3 mm in any axis plus \> 1 brain T2 lesions
Exclusion Criteria
- •Patients will be excluded from enrollment in this study if they meet any of the following criteria:
- •Previous treatment with alemtuzumab
- •Current participation in another clinical study or previous participation in CAMMS323
- •Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Patients who received one of these medications more than 6 months before the date the ICF is signed may be eligible for study entry if approval is granted by the sponsor
- •Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids)
- •Previous treatment with any investigational medication (drug has not been approved at any dose or for any indication) unless prior approval is granted by the sponsor and the patient completes any required washout. Use of an investigational medication that was subsequently licensed and nonstandard use of a licensed medication (eg, using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) is not exclusionary. Prior treatment with herbal medications or nutritional supplements is also permitted.
- •Any progressive form of MS
- •History of malignancy, except basal skin cell carcinoma
- •Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS
- •Previous hypersensitivity reaction to any immunoglobulin product
Outcomes
Primary Outcomes
The primary study objective is to demonstrate whether treatment with alemtuzumab is effective in stabilizing overall neurocognitive functioning in relapsing-remitting multiple sclerosis over time.
Time Frame: Four years
To determine the rate of change in cognitive scores for RRMS participants taking alemtuzumab over time. The data from participants in this trial will be compared to data from normal controls and RRMS patients receiving Rebif® in a parallel trial conducted by Wilken et al (in preparation).