Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients

NCT01333358 | Unknown Phase 3

• 1 other identifier: IND 111746
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Relapsing; remitting

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  Four years

Interventions

Alemtuzumab DRUG

Alemtuzumab 12mg given intravenously each day for five days and again twelve months later for an additional three days

Also known as: Campath Mabcampath

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• a spinal cord lesion consistent with MS plus \> 1 brain T2 lesions
• Corrected vision of subjects must be no worse than 20/50.
• Participants must have at least 10 years of education.
• Participants must be capable of writing and pressing the buttons on a computer mouse.
• Participants must be capable of understanding and following all test instructions.

You may not qualify if:

• 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)
• 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
• Known allergy or intolerance to interferon beta, human albumin, or mannitol
• Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
• Inability to self-administer SC injections or receive SC injections from caregiver
• Inability to undergo MRI with gadolinium administration
• 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
• Absolute neutrophil count \< LLN at Screening; if abnormal cell count returns to within normal limits, eligibility may be reassessed

Sponsors & Collaborators

• Central Texas Neurology Consultants: lead
• Genzyme, a Sanofi Company: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Edward J Fox, MD,PhD

  Central Texas Neurology Consultants

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Mayer, RN, MSCN, CCRP

CONTACT

512-218-1222; lorimayer@sbcglobal.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 25, 2011

Record last verified: 2011-04