Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis (ITT-PMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Umeå University.
Recruitment status was  Recruiting
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Anders Svenningsson, Umeå University Identifier:
First received: October 25, 2012
Last updated: October 29, 2012
Last verified: October 2012

This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.

Condition Intervention Phase
Progressive Multiple Sclerosis
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: One year after completed treatment ] [ Designated as safety issue: Yes ]
    Feasibility of IT administered monoclonal antibodies

Secondary Outcome Measures:
  • Stabilisation of the neurological deterioration [ Time Frame: At 3,6,9,12 month after completed treatment ] [ Designated as safety issue: No ]
    Questionaires regarding MS quality of life, symptom inventory and fatigue will be used.

Other Outcome Measures:
  • Immunological markers in blood [ Time Frame: At 3,6,9,12 month after treatment ] [ Designated as safety issue: No ]
    I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset

  • Immunological markers in cerebrospinal fluid (CSF) [ Time Frame: At 3, 6, 9 12 month after treatment ] [ Designated as safety issue: No ]
    I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
Drug: Rituximab
Other Name: Mabthera

Detailed Description:

There is presently no efficient therapy available in progressive MS, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. There are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. One specific feature of long-standing MS is that inflammatory cells accumulate in the central nervous system(CNS) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. Administration of substances via the Intrathecal (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)
  • Progressive MS since at least three years
  • Some kind of documented progression of neurological symptoms during the previous two years.
  • Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)
  • Conventional therapy not indicated, contraindicated or failed
  • Judged as compliant with the protocol

Exclusion Criteria:

  • Eligible for any of the conventional MS therapies
  • Relapsing remitting multiple sclerosis (RRMS)
  • Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
  • Cognitive defect making informed consent unreliable
  • Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist
  • Severe, uncontrolled heart disease
  • Pregnant or lactating women
  • Patients having contraindication for or otherwise not compliant with MRI investigations
  • Documented vulnerability to infections
  • Simultaneous treatment with other immunosuppressive drugs
  • Documented allergy or intolerance to Rituximab
  • Severe psychiatric condition
  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 identifier: NCT01719159

Contact: Anders Svenningsson, MD, PhD +46 90 785 ext 1933

Department of neurology, Umeå University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Anders Svenningsson, MD, PhD    +46 90785 ext 1933   
Principal Investigator: Anders Svenningsson, MD, PhD         
Dept of neurology, Uppsala University Hospital Not yet recruiting
Uppsala, Sweden, SE-751 85
Contact: Joachim Burman, MD   
Principal Investigator: Joachim Burman, MD         
Sponsors and Collaborators
Anders Svenningsson
Västerbotten County Council, Sweden
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
  More Information

No publications provided

Responsible Party: Anders Svenningsson, MD, PhD, Assoc Prof, Umeå University Identifier: NCT01719159     History of Changes
Other Study ID Numbers: ITT-PMS
Study First Received: October 25, 2012
Last Updated: October 29, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Umeå University:
Progressive multiple sclerosis
Monoclonal antibodies
Intrathecal treatment

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 27, 2015