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

November 18, 2016 updated by: Anders Svenningsson
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 901 85
        • Department of neurology, Umeå University Hospital
      • Uppsala, Sweden, SE-751 85
        • Dept of neurology, Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
Drug: Rituximab
25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.
Other Names:
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: One year after completed treatment
Feasibility of IT administered monoclonal antibodies
One year after completed treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stabilisation of the neurological deterioration
Time Frame: At 3,6,9,12 month after completed treatment
Questionaires regarding MS quality of life, symptom inventory and fatigue will be used.
At 3,6,9,12 month after completed treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological markers in blood
Time Frame: At 3,6,9,12 month after treatment
I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset
At 3,6,9,12 month after treatment
Immunological markers in cerebrospinal fluid (CSF)
Time Frame: At 3, 6, 9 12 month after treatment
I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset
At 3, 6, 9 12 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Svenningsson

Collaborators

Västerbotten County Council, Sweden

Investigators

  • Principal Investigator: Anders Svenningsson, MD, PhD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITT-PMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD will be shared upon request from the researcher or scientific journals

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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