Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

Progressive Multiple Sclerosis Clinical Trial

— ITT-PMS  

Official title:

Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719159
• Other study ID #: ITT-PMS
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2012
• Last updated: November 18, 2016
• Start date: November 2009
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of neurology, Umeå University Hospital	Umeå
Sweden	Dept of neurology, Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Anders Svenningsson	Västerbotten County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunological markers in blood	I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset	At 3,6,9,12 month after treatment	No
Other	Immunological markers in cerebrospinal fluid (CSF)	I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset	At 3, 6, 9 12 month after treatment	No
Primary	Number of participants with adverse events	Feasibility of IT administered monoclonal antibodies	One year after completed treatment	Yes
Secondary	Stabilisation of the neurological deterioration	Questionaires regarding MS quality of life, symptom inventory and fatigue will be used.	At 3,6,9,12 month after completed treatment	No