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

NCT00276380 | Completed Phase 3 Results

• 1 other identifier: A-38-00240-704
• Study Type: interventional
• Target: 204
• Locations: 4 countries
• Sites: 10

Brief Summary

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

Stroke, Acute; Neurological Impairment

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.

  The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score\<3 at the end of the study (Day 168) are reported.

  Day 168

Secondary Outcomes (6)

• Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.

  Up to Day 84

• Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.

  Up to Day 168

• Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.

  Up to Day 168

• Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.

  Up to Day 168

• Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.

  Up to Day 168

Study Arms (2)

EGb761®

EXPERIMENTAL

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.

Drug: EGb761; Drug: Acetylsalicylic acid

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Acetylsalicylic acid

Interventions

EGb761 DRUG

EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.

Also known as: Tanakan

EGb761®

Placebo DRUG

Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.

Placebo

Acetylsalicylic acid DRUG

Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.

EGb761®; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5)
• Patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time) test in the normal values of the laboratory

You may not qualify if:

• Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8 days prior
• Patient with known pre-existent cerebral infarction
• Infarct damaged area bigger than 1/3 hemisphere
• Patient having a score below the cut-off point at Frenchay Aphasia Short Test

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Faculty of Medicine in Hradec Kralove

Hradec Králové, 500 02, Czechia

Location

General Faculty Hospital

Prague, 120 00, Czechia

Location

Department and Clinic of Neurology of the Old Age

Katowice, 40 752, Poland

Location

CMUJ Krakov

Krakow, 31503, Poland

Location

Postgraduate Medical Teaching Center

Warsaw, 00 416, Poland

Location

Institul de Boli Cerebro Vascular

Bucharest, 75622, Romania

Location

Spitalul Universitar de Urgenta

Bucharest, Sector 5, Romania

Location

Russian State Medical University - Neurology and Neurosurgery Clinic

Moscow, 117415, Russia

Location

Russian State Medical University - Dept Fundamental Neurology & Neurosurgery

Moscow, 129327, Russia

Location

Ural State Medical Academy

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

Stroke; Neurologic Manifestations

Interventions

Ginkgo biloba extract; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: February 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 8, 2019
• Results First Posted: February 19, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2); PL (3); CZ (2); RU (3)