NCT00331747

Brief Summary

Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients. During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
Last Updated

July 7, 2006

Status Verified

July 1, 2006

First QC Date

May 30, 2006

Last Update Submit

July 5, 2006

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Computerized gait analysis: at the beginning of treatment and after 1 year

Interventions

Glatiramer acetateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of multiple sclerosis
  • EDSS less than 5.5
  • No cognitive disability

You may not qualify if:

  • EDSS over 5.5
  • Inability to cooperate with gait analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center, Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Uri Givon, MD

    Sheba Medical Center; Tel Aviv University

    PRINCIPAL INVESTIGATOR

  • Anat Achiron, MD, PhD

    Sheba Medical Center; Tel Aviv University

    STUDY CHAIR

Central Study Contacts

Uri Givon, MD

CONTACT

+972-35304451urigi@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

May 1, 2006

Last Updated

July 7, 2006

Record last verified: 2006-07

Locations

IL(1)