NCT00220428

Brief Summary

The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 24, 2007

Status Verified

January 1, 2007

First QC Date

September 14, 2005

Last Update Submit

January 23, 2007

Conditions

Multiple Sclerosis

Keywords

T cell

Outcome Measures

Primary Outcomes (1)

  • safety assessment of T-cell vaccination in nonresponding MS patients

Interventions

T-Cell VaccinationBIOLOGICAL

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Definite MS (post criteria)
  • Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
  • Disease duration \> 1 year
  • Expanded Disability Status Scale (EDSS) between 0-6
  • Brain magnetic resonance imaging (MRI) compatible with MS
  • Not involved in any other clinical trials
  • No other systemic disease

You may not qualify if:

  • Does not comply with the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anat Achiron, MD PhD

    Sackler School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Achiron, MD PhD

CONTACT

972-3-5303932ACHIRON@POST.TAU.AC.IL

Matilda Mandel, MD

CONTACT

972-3-5305309

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

July 1, 1998

Study Completion

December 1, 2007

Last Updated

January 24, 2007

Record last verified: 2007-01

Locations

IL(1)