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OpenTrials
Completed

NCT Number: NCT00276341

Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis

The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Multiple Sclerosis Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with Multiple Sclerosis Relapsing-Remitting form
  • Patient with cognitive impairment (as spontaneous complaint by either patient or family)
  • Patient treated with interferon and maintaining same dosage for previous 6 months
  • Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)

Exclusion criteria

  • Clinical Multiple Sclerosis relapse within 3 months prior to participation
  • Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
  • Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)

Treatment and study plan

EGb 761® (Tanakan®)

Drug

Primary outcomes

  1. Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24

Secondary outcomes

  1. Evolution of the following tests between baseline and week 24:

  2. Multiple Sclerosis Functional Composite Test

  3. Selective Reminding Test

  4. 10/36 Visual-Spatial Recall Test

  5. Symbol Digit Modalities Test

  6. Trail Making Test A and B

  7. Verbal Fluency Test

  8. Empan Test

  9. Evolution of the following scales between baseline and week 24:

  10. Cognitive Deficit Interview based screen

  11. Anxiety Brief Scale

  12. Beck Depression Inventory Scale

  13. Modified Fatigue Impact Scale

  14. Evolution of Quality of Life

  15. Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.

Important dates

Study start
2003
Study completion
2005
First posted
Jan 13, 2006
Registry last updated
Mar 7, 2024

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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