NCT00267319

Brief Summary

  • The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
  • Secondary outcome measures are:disability, relapse rate, quality of life and depression.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P75+ for phase_4 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

3.3 years

First QC Date

December 19, 2005

Last Update Submit

December 4, 2009

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • fatigue impact scale

    at baseline, month 6 and month 12

Secondary Outcomes (5)

  • relapse rate

    at baseline, month 6 and month 12

  • quality of life

    at baseline, month 6 and month 12

  • depression

    at baseline, month 6 and month 12

  • disability

    at baseline, month 6 and month 12

  • Adverse events

    at baseline, month 6 and month 12

Study Arms (1)

single group

EXPERIMENTAL
Drug: Glatiramer acetate

Interventions

Glatiramer acetateDRUG
single group

Eligibility Criteria

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

You may qualify if:

  • relapsing-remitting Multiple Sclerosis (MS),
  • at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
  • ambulant patients i.e disability score EDSS MAX 5,5,
  • clinically stable MS
  • relapse free and steroid free at least 30 days prior to start copaxone treatment

You may not qualify if:

  • hypersensitivity to glatiramer acetate or mannitol,
  • pregnancy,
  • fertile female not willing to use effective contraception,
  • previous treatment with copaxone
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Prague, Czechia

Location

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

  • Zuzana Priborska

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2006

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

CZ(1)