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

NCT01883011 | Terminated Phase 4 DMC

• 1 other identifier: N09642
• Study Type: interventional
• Target: 571
• Locations: 15 countries
• Sites: 44

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.

Conditions

Acute Ischaemic Middle Cerebral Artery Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84

  FAST describes the presence, absence or severity of aphasia, but does not differentiate types of aphasia. Comprehension, expression and reading were main score targets tested by picture card with attached reading card. The FAST score covered a range from 0-20. Subjects with FAST score ≤13 where considered as aphasic and subjects with FAST score \> 13 were considered as non-aphasic. There were 2 tests of comprehension and 2 tests of expression and 1 of reading, however the reading test was not included in the primary efficacy variable.

  Day 84

Secondary Outcomes (3)

• Middle Cerebral Artery infarction scale (MCA) score at Day 84

  Day 84

• Total Barthel Index (BI) score at Day 84

  Day 84

• Mini Mental State Examination (MMSE) score at Day 84

  Day 84

Study Arms (2)

Piracetam

EXPERIMENTAL

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)

Drug: Piracetam

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Piracetam DRUG

Piracetam

Placebo OTHER

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female adults ≥ 50 years
• Considered as reliable and mentally capable of adhering to the protocol
• Clinical diagnosis of a middle cerebral artery ischemic stroke
• 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

You may not qualify if:

• 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:
• \. in functional ability or autonomy
• \. in motor function
• \. in cognitive capacities
• \. in language
• A systemic disease with neurological symptoms
• A life threatening disease with life expectancy of less than 1 year
• \. 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)
• \. Thrombolytics: recombinant tissue-type plasminogen activator (alteplase) (rt- PA), streptokinase, urokinase, ancrod
• \. Hemodilution
• \. Glucose infusion \>5 %
• Subjects known to not being able to be followed for 12 weeks
• Known alcohol or drug addiction or abuse

Sponsors & Collaborators

• UCB S.A. - Pharma Sector: lead

Study Sites (44)

050

Buenos Aires, Argentina

Location

051

Buenos Aires, Argentina

Location

004

Inssbruck, Austria

Location

001

Linz, Austria

Location

003

Linz, Austria

Location

102

Antwerp, Belgium

Location

103

Antwerp, Belgium

Location

104

Brussels, Belgium

Location

107

Genk, Belgium

Location

150

Charleville-Mézières, France

Location

152

Nice, France

Location

201

Magdeburg, Germany

Location

200

Minden, Germany

Location

203

Nidda-bad-Salzhausen, Germany

Location

202

Saarbrücken, Germany

Location

251

Athens, Greece

Location

252

Athens, Greece

Location

302

Budapest, Greece

Location

303

Budapest, Greece

Location

305

Budapest, Greece

Location

250

Thessaloniki, Greece

Location

300

Budapest, Hungary

Location

304

Debrecen, Hungary

Location

301

Miskolc, Hungary

Location

350

Perugia, Italy

Location

750

Bergen, Norway

Location

455

Bialystok, Poland

Location

454

Krakow, Poland

Location

456

Lodz, Poland

Location

451

Poznan, Poland

Location

450

Warsaw, Poland

Location

452

Warsaw, Poland

Location

600

Singapore, Singapore

Location

601

Singapore, Singapore

Location

501

Madrid, Spain

Location

502

Madrid, Spain

Location

503

Málaga, Spain

Location

500

Terrassa, Spain

Location

550

Stockholm, Sweden

Location

700

Taipei, Taiwan

Location

654

Edirne, Turkey (Türkiye)

Location

650

Eskişehir, Turkey (Türkiye)

Location

652

Istanbul, Turkey (Türkiye)

Location

653

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Aphasia; Ischemia

Interventions

Piracetam

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: August 1, 1998
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

AU (3); GR (6); DE (4); IT (1); SE (1); TU (4); PL (6); ES (4); NO (1); HU (3); SG (2); TW (1); BE (4); FR (2); AR (2)