A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke

Completed

Phase 3 Results

Trial Description

The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.

Conditions

Interventions

  • Aspirin Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Placebo Drug
    Intervention Desc: Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
  • EGb761 (Tanakan)Drug
    Other Names: Tanakan
    Intervention Desc: EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
    ARM 1: Kind: Experimental
    Label: EGb761®
    Description: EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
  • EGb761 (Tanakan) and acetylsalicylic acid Drug
    Intervention Desc: EGb761 (Tanakan) 40mg tablets (2 tablets tid) 240mg/day AND acetylsalicylic acid (1 tablet once daily), 325 mg/day, for 6 months
    ARM 1: Kind: Experimental
    Label: 1
  • Placebo and acetylsalicylic acid Drug
    Intervention Desc: Placebo 40 mg tablets (2 tablets tid) AND acetylsalicylic acid, 325 mg/day (1 tablet once daily) for 6 months
    ARM 1: Kind: Experimental
    Label: 2
  • Acetylsalicylic acid Drug
    Other Names: Aspirin 81 mg
    Intervention Desc: Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
    ARM 1: Kind: Experimental
    Label: EGb761®
    Description: EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients are randomized to one of two arms: Experimental arm with Drug: EGb761 (Tanakan) and acetylsalicylic acid EGb761 (Tanakan) 40mg tablets (2 tablets tid) 240mg/day AND acetylsalicylic acid (1 tablet once daily), 325 mg/day, for 6 months or placebo comparator with Drug: Placebo and acetylsalicylic acid Placebo 40 mg tablets (2 tablets tid) AND acetylsalicylic acid, 325 mg/day (1 tablet once daily) for 6 months. Patients will have baseline and 6 month evaluation withBarthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.

Outcomes

Type Measure Time Frame Safety Issue
Primary Patients with Modified Rankin score 0 or 1 or 2 at the end of study period.
Secondary Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.
Secondary Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State 6 months No
Primary Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. Day 168
Secondary Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. Up to Day 84
Secondary Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. Up to Day 168
Secondary Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. Up to Day 168
Secondary Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. Up to Day 168
Secondary Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. Up to Day 168
Secondary Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168. Up to Day 168

Sponsors