Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients (CAMA-2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Central Texas Neurology Consultants.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Central Texas Neurology Consultants
ClinicalTrials.gov Identifier:
NCT01333358
First received: April 8, 2011
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Alemtuzumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Central Texas Neurology Consultants:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Alemtuzumab
    Alemtuzumab 12mg given intravenously each day for five days and again twelve months later for an additional three days
    Other Name: Campath Mabcampath
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form (ICF)
  2. Age 18 to 55 years old (inclusive) as of the date the ICF is signed
  3. Diagnosis of MS per McDonald criteria (2005 update).
  4. Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed
  5. EDSS score 0.0 to 5.0 (inclusive) at Screening
  6. ≥ 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.
  7. ≥ 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
  8. 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
    • a spinal cord lesion consistent with MS plus > 1 brain T2 lesions
  9. Corrected vision of subjects must be no worse than 20/50.
  10. Participants must have at least 10 years of education.
  11. Participants must be capable of writing and pressing the buttons on a computer mouse.
  12. Participants must be capable of understanding and following all test instructions.

Exclusion Criteria:

Patients will be excluded from enrollment in this study if they meet any of the following criteria:

  1. Previous treatment with alemtuzumab
  2. Current participation in another clinical study or previous participation in CAMMS323
  3. 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
  4. Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids)
  5. 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.
  6. Any progressive form of MS
  7. History of malignancy, except basal skin cell carcinoma
  8. Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS
  9. Previous hypersensitivity reaction to any immunoglobulin product
  10. Known allergy or intolerance to interferon beta, human albumin, or mannitol
  11. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
  12. Inability to self-administer SC injections or receive SC injections from caregiver
  13. Inability to undergo MRI with gadolinium administration
  14. Confirmed platelet count < the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at <100,000/μL within the past year on a sample without platelet clumping
  15. Absolute neutrophil count < LLN at Screening; if abnormal cell count returns to within normal limits, eligibility may be reassessed
  16. Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation [DIC], fibrinogen deficiency, clotting factor deficiency)
  17. Seropositivity for human immunodeficiency virus (HIV)
  18. Significant autoimmune disease including but not limited to: immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis.
  19. Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
  20. In the Investigator's opinion, is at high risk for infection (eg, indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
  21. Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
  22. Infection with hepatitis C virus
  23. Past or present hepatitis B infection (positive hepatitis B serology)
  24. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating
  25. Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only). Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap (diaphragm or cervical cap with spermicide).
  26. Major psychiatric disorder that is not adequately controlled by treatment
  27. Epileptic seizures that are not adequately controlled by treatment
  28. Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that may predispose to hemorrhage
  29. Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
  30. Prior history of invasive fungal infections
  31. Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS). The patient may be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated).
  32. Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by either study medication
  33. Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome, unless, in the Investigator's opinion, the abnormality is due to a condition that has resolved (eg, recent interferon treatment subsequently discontinued) and levels return to within normal limits. See Table below, drawn from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE), published 09 August 2006.

    • Hepatic
    • Bilirubin > 1.5 × ULN
    • SGOT/AST > 2.5 × ULN
    • SGPT/ALT > 2.5 × ULN
    • Alkaline phosphatase > 2.5 × ULN
    • Renal
    • Creatinine > 1.5 × ULN
  34. Participants with upper extremity dysfunction which prohibits them from using a computer mouse.
  35. Participants who are colorblind.
  36. Participants with current alcohol/substance abuse.
  37. Participants taking medications with notable adverse CNS effects such as excessive sedation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333358

Contacts
Contact: Lori Mayer, RN, MSCN, CCRP 512-218-1222 lorimayer@sbcglobal.net

Sponsors and Collaborators
Central Texas Neurology Consultants
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Edward J Fox, MD,PhD Central Texas Neurology Consultants
  More Information

No publications provided

Responsible Party: Central Texas Neurology Consultants, Corporation
ClinicalTrials.gov Identifier: NCT01333358     History of Changes
Other Study ID Numbers: IND 111746
Study First Received: April 8, 2011
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Central Texas Neurology Consultants:
Relapsing
remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014