Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00331747

Purpose

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.

Condition	Intervention
Multiple Sclerosis	Drug: Glatiramer acetate

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	May 2006

Detailed Description:

Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.

Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.

Repeat gait analysis will be performed after one year of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

EDSS over 5.5
Inability to cooperate with gait analysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331747

Contacts

Contact: Uri Givon, MD

+972-35304451

urigi@sheba.health.gov.il

Locations

Israel
Multiple Sclerosis Center, Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Uri Givon, MD

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Uri Givon, MD	Sheba Medical Center; Tel Aviv University
Study Chair:	Anat Achiron, MD, PhD	Sheba Medical Center; Tel Aviv University

More Information

Study ID Numbers:	SHEBA-05-3985-UG-CTIL
Study First Received:	May 30, 2006
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00331747
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Copolymer 1
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Adjuvants, Immunologic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009