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

UCB

Status and phase: Terminated; Phase 4

Conditions: Acute Ischaemic Middle Cerebral Artery Stroke

Treatments: Other: Placebo; Drug: Piracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01883011

N09642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 571 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

571 participants in 2 patient groups, including a placebo group

Piracetam

Experimental group

Description:

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)

Treatment:

Drug: Piracetam

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo