Back to resultsA Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
Primary Purpose
Acute Ischaemic Middle Cerebral Artery Stroke
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Piracetam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischaemic Middle Cerebral Artery Stroke focused on measuring Piracetam, Stroke, Aphasia, Acute, Cerebral, Ischemic, Nootropil
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)
Sites / Locations
- 050
- 051
- 004
- 001
- 003
- 102
- 103
- 104
- 107
- 150
- 152
- 201
- 200
- 203
- 202
- 251
- 252
- 302
- 303
- 305
- 250
- 300
- 304
- 301
- 350
- 750
- 455
- 454
- 456
- 451
- 450
- 452
- 600
- 601
- 501
- 502
- 503
- 500
- 550
- 700
- 654
- 650
- 652
- 653
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Piracetam
Placebo
Arm 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)
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Middle Cerebral Artery infarction scale (MCA) score at Day 84
The MCA was developed for clinical trial evaluation of middle cerebral artery stroke. The scale evaluates 10 items: consciousness, verbal communication, elevation of the arm, finger and thumb movements, arm tone, deviation of head and eyes, facial movements, elevation of the leg, dorsiflexion of the foot and leg tone. Weighted scores for each item provide a maximum score of 100.
Total Barthel Index (BI) score at Day 84
This scale evaluates 10 items: eating, moving from (wheel) chair to bed and back, personal hygiene, using the lavatory, bathing, walking/wheelchair, stairs, getting dressed/undressed, controlling bowel motion, controlling bladder.
Weighted scores for each item vary between 0 and 15 to provide a maximum score of 100. Subjects who can perform all specified activities without help receive a score of 100. Even though they are independent in daily activities, they could remain handicapped by neurologic impairments.
Mini Mental State Examination (MMSE) score at Day 84
The MMSE is divided into two sections, the first of which requires vocal responses only and covers orientation, memory and attention: the maximum score is 21.
The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously and copy a complex polygon: the maximum score is 9. Maximum score of the two parts is 30. The test is not timed. A score ≤ 23 indicates that the subject is demented.
Full Information
NCT ID
NCT01883011
First Posted
June 18, 2013
Last Updated
August 28, 2013
Sponsor
UCB S.A. - Pharma Sector
1. Study Identification
Unique Protocol Identification Number
NCT01883011
Brief Title
A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
Official Title
Randomized, Double Blind, Placebo Controlled, Two Parallel Group Study to Evaluate the Efficacy and Safety of Piracetam, 12 g Intravenous (IV) Infusion Within 7 Hour (h) Post Stroke Onset, Followed by 12 g/d for 4 Weeks (IV Ampoules, Oral Solution) and 4.8 g/d for 8 Weeks (Tablets) in Adult Subjects With an Acute Ischemic Middle Cerebral Artery Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.
Study Start Date
August 1998 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
July 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB S.A. - Pharma Sector
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischaemic Middle Cerebral Artery Stroke
Keywords
Piracetam, Stroke, Aphasia, Acute, Cerebral, Ischemic, Nootropil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
571 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piracetam
Arm Type
Experimental
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Piracetam
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84
Description
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.
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Middle Cerebral Artery infarction scale (MCA) score at Day 84
Description
The MCA was developed for clinical trial evaluation of middle cerebral artery stroke. The scale evaluates 10 items: consciousness, verbal communication, elevation of the arm, finger and thumb movements, arm tone, deviation of head and eyes, facial movements, elevation of the leg, dorsiflexion of the foot and leg tone. Weighted scores for each item provide a maximum score of 100.
Time Frame
Day 84
Title
Total Barthel Index (BI) score at Day 84
Description
This scale evaluates 10 items: eating, moving from (wheel) chair to bed and back, personal hygiene, using the lavatory, bathing, walking/wheelchair, stairs, getting dressed/undressed, controlling bowel motion, controlling bladder.
Weighted scores for each item vary between 0 and 15 to provide a maximum score of 100. Subjects who can perform all specified activities without help receive a score of 100. Even though they are independent in daily activities, they could remain handicapped by neurologic impairments.
Time Frame
Day 84
Title
Mini Mental State Examination (MMSE) score at Day 84
Description
The MMSE is divided into two sections, the first of which requires vocal responses only and covers orientation, memory and attention: the maximum score is 21.
The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously and copy a complex polygon: the maximum score is 9. Maximum score of the two parts is 30. The test is not timed. A score ≤ 23 indicates that the subject is demented.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493
Official's Role
Study Director
Facility Information:
Facility Name
050
City
Buenos Aires
Country
Argentina
Facility Name
051
City
Buenos Aires
Country
Argentina
Facility Name
004
City
Inssbruck
Country
Austria
Facility Name
001
City
Linz
Country
Austria
Facility Name
003
City
Linz
Country
Austria
Facility Name
102
City
Antwerpen
Country
Belgium
Facility Name
103
City
Antwerpen
Country
Belgium
Facility Name
104
City
Brussels
Country
Belgium
Facility Name
107
City
Genk
Country
Belgium
Facility Name
150
City
Charleville-Mezieres
Country
France
Facility Name
152
City
Nice cedex 1
Country
France
Facility Name
201
City
Magdeburg
Country
Germany
Facility Name
200
City
Minden
Country
Germany
Facility Name
203
City
Nidda-bad-Salzhausen
Country
Germany
Facility Name
202
City
Saarbrucken
Country
Germany
Facility Name
251
City
Athens
Country
Greece
Facility Name
252
City
Athens
Country
Greece
Facility Name
302
City
Budapest
Country
Greece
Facility Name
303
City
Budapest
Country
Greece
Facility Name
305
City
Budapest
Country
Greece
Facility Name
250
City
Thessaloniki
Country
Greece
Facility Name
300
City
Budapest
Country
Hungary
Facility Name
304
City
Debrecen
Country
Hungary
Facility Name
301
City
Miskolc
Country
Hungary
Facility Name
350
City
Perugia
Country
Italy
Facility Name
750
City
Bergen
Country
Norway
Facility Name
455
City
Bialystok
Country
Poland
Facility Name
454
City
Krakow
Country
Poland
Facility Name
456
City
Lodz
Country
Poland
Facility Name
451
City
Poznan
Country
Poland
Facility Name
450
City
Warsaw
Country
Poland
Facility Name
452
City
Warszawa
Country
Poland
Facility Name
600
City
Singapore
Country
Singapore
Facility Name
601
City
Singapore
Country
Singapore
Facility Name
501
City
Madrid
Country
Spain
Facility Name
502
City
Madrid
Country
Spain
Facility Name
503
City
Malaga
Country
Spain
Facility Name
500
City
Terrassa
Country
Spain
Facility Name
550
City
Stockholm
Country
Sweden
Facility Name
700
City
Taipei
Country
Taiwan
Facility Name
654
City
Edirne
Country
Turkey
Facility Name
650
City
Eskisehir
Country
Turkey
Facility Name
652
City
Istanbul
Country
Turkey
Facility Name
653
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
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