A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke

NCT ID: NCT01883011

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 571 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2001-07-31

Brief Summary

The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral artery stroke and having received their medication within 7 h post-stroke onset.

Detailed Description

An interim analysis was performed, as planned in the protocol, on the primary efficacy measure (Day 84 FAST Score) for aphasic subjects. This interim analysis indicated that there was less than a 20 % chance of showing a 15 % difference between placebo and piracetam at the end of the trial, under the assumption that there was indeed a 15 % difference. Thus, it was the decision of UCB to stop further recruitment into this study.

Conditions

Acute Ischaemic Middle Cerebral Artery Stroke

Keywords

Piracetam; Stroke; Aphasia; Acute; Cerebral; Ischemic; Nootropil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Piracetam

IV infusion 12 g piracetam in 60 ml

IV Ampoules 3 g piracetam in 15 ml

Oral solution 33 % piracetam (bottle of 125 ml)

Oral tablets 1200 mg piracetam (blisters of 10 tablets)

Group Type: EXPERIMENTAL

Piracetam

Intervention Type: DRUG

Placebo

IV infusion 12 g placebo in 60 ml

IV Ampoules 3 g placebo in 15 ml

Oral solution 33% placebo (bottle of 125 ml)

Oral tablets 1200 mg placebo (blisters of 10 tablets)

All IV forms were identical in presentation, size and color to allow a double blind design.

All oral forms were identical in shape, size, color and taste to allow a double blind design.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Piracetam

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female adults ≥ 50 years
• Considered as reliable and mentally capable of adhering to the protocol
• Signed informed consent (by the subject or the next of kin) or inclusion of the subject as per Ethics Committee approved procedures
• Clinical diagnosis of a middle cerebral artery ischemic stroke
• A disabling motor deficit at the moment of inclusion, defined as having a total Middle Cerebral Artery (MCA) score between 15 and 65
• Treated before 7 h (6 h and 59 minutes) after the estimated stroke onset
• If the subject had a stroke during the night, the onset of stroke is assumed to be the last time the subject was seen awake and normal, or last time the subject remembered he/she was awake and normal
• Being aphasic, defined as having an Aphasia Severity Rating (ASR) score of < 3

Exclusion Criteria

• Stupor or coma: < 10 on the item consciousness of the Middle Cerebral Artery (MCA) scale
• A previous stroke with clinical sequel or a previous stroke with aphasia (even in case of complete recovery from aphasia)
• A medical or neurological disease interfering with the assessments and causing a clear deficit:
• 1. in functional ability or autonomy
• 2. in motor function
• 3. in cognitive capacities
• 4. in language
• A systemic disease with neurological symptoms
• A life threatening disease with life expectancy of less than 1 year
• Renal insufficiency (creatinine > 2 mg/100 ml or > 180 µmol/l; creatinine had to be determined as soon as possible but not before inclusion)
• Any concomitant treatments that could not be stopped at the moment of inclusion or that had been started after the onset of the stroke and before inclusion (as long as not considered by the advisory board as effective drug), such as:
• 1. Cerebro-vascular active products: bufenine, buflomedil, cinnarizine, codergocrinemesilate, citicholine, cyclandelate, cyprodemanol, deanolacetamidobenzoate, flunarizine, ginkgo-biloba extr., inositolnicotinate, isoxsuprine, meclofenoxate, naftidrofuryloxalate, nicergoline, nicotinic acid (smoking is allowed), nimodipine, pentifylline, papaverine, pentoxifylline, piracetam, pyrisuccideanoldimaleate, pyritinol, raubasine, vincamine, viquidil, xantinolnicotinate. A list of these drugs with generic and brand name, adapted to each of the participating countries accompanied the Case Report Form (CRF)
• 2. Thrombolytics: recombinant tissue-type plasminogen activator (alteplase) (rt- PA), streptokinase, urokinase, ancrod
• 3. Hemodilution
• 4. Glucose infusion >5 %
• Subjects known to not being able to be followed for 12 weeks
• Known alcohol or drug addiction or abuse
• Subjects previously enrolled in this trial
• Known allergy/intolerance to piracetam/excipients
• Lactation, pregnancy, or pregnancy potential, unless using an effective means of contraception
• Illiterate subjects (subjects not able to read prior to stroke)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB S.A. - Pharma Sector

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493

Locations

050

Buenos Aires, , Argentina

051

Buenos Aires, , Argentina

004

Inssbruck, , Austria

001

Linz, , Austria

003

Linz, , Austria

102

Antwerp, , Belgium

103

Antwerp, , Belgium

104

Brussels, , Belgium

107

Genk, , Belgium

150

Charleville-Mézières, , France

152

Nice, , France

201

Magdeburg, , Germany

200

Minden, , Germany

203

Nidda-bad-Salzhausen, , Germany

202

Saarbrücken, , Germany

251

Athens, , Greece

252

Athens, , Greece

302

Budapest, , Greece

303

Budapest, , Greece

305

Budapest, , Greece

250

Thessaloniki, , Greece

300

Budapest, , Hungary

304

Debrecen, , Hungary

301

Miskolc, , Hungary

350

Perugia, , Italy

750

Bergen, , Norway

455

Bialystok, , Poland

454

Krakow, , Poland

456

Lodz, , Poland

451

Poznan, , Poland

450

Warsaw, , Poland

452

Warsaw, , Poland

600

Singapore, , Singapore

601

Singapore, , Singapore

501

Madrid, , Spain

502

Madrid, , Spain

503

Málaga, , Spain

500

Terrassa, , Spain

550

Stockholm, , Sweden

700

Taipei, , Taiwan

654

Edirne, , Turkey (Türkiye)

650

Eskişehir, , Turkey (Türkiye)

652

Istanbul, , Turkey (Türkiye)

653

Istanbul, , Turkey (Türkiye)

Countries

Argentina; Austria; Belgium; France; Germany; Greece; Hungary; Italy; Norway; Poland; Singapore; Spain; Sweden; Taiwan; Turkey (Türkiye)

Other Identifiers

N09642

Identifier Type: -

Identifier Source: org_study_id