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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276341
First received: January 12, 2006
Last updated: May 15, 2006
Last verified: May 2006

January 12, 2006
May 15, 2006
August 2003
Not Provided
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Same as current
Complete list of historical versions of study NCT00276341 on ClinicalTrials.gov Archive Site
  • Evolution of the following tests between baseline and week 24:
  • Multiple Sclerosis Functional Composite Test
  • Selective Reminding Test
  • 10/36 Visual-Spatial Recall Test
  • Symbol Digit Modalities Test
  • Trail Making Test A and B
  • Verbal Fluency Test
  • Empan Test
  • Evolution of the following scales between baseline and week 24:
  • Cognitive Deficit Interview based screen
  • Anxiety Brief Scale
  • Beck Depression Inventory Scale
  • Modified Fatigue Impact Scale
  • Evolution of Quality of Life
  • Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change
Same as current
Not Provided
Not Provided
 
Study on the Effectiveness of EGb 761® Vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Drug: EGb 761® (Tanakan®)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00276341
2-39-00240-126
Not Provided
Not Provided
Ipsen
Not Provided
Study Director: Mehemed Ouzid, MD Ipsen
Ipsen
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP