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OpenTrials
Completed

NCT Number: NCT00267319

FOCUS Fatigue Outcome in Copaxone USers

* 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Glatiramer Acetate

Drug

Primary outcomes

  1. fatigue impact scale

    Time frame: at baseline, month 6 and month 12

Secondary outcomes

  1. relapse rate

    Time frame: at baseline, month 6 and month 12

  2. quality of life

    Time frame: at baseline, month 6 and month 12

  3. depression

    Time frame: at baseline, month 6 and month 12

  4. disability

    Time frame: at baseline, month 6 and month 12

  5. Adverse events

    Time frame: at baseline, month 6 and month 12

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Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Important dates

Study start
2003
Primary completion
2006
First posted
Dec 20, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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