Acute Ischaemic Middle Cerebral Artery StrokePhase 4NCT01883011
A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
A Phase 4 study testing Piracetam in people with Acute Ischaemic Middle Cerebral Artery Stroke, run by UCB S.A. - Pharma Sector at 44 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Ischaemic Middle Cerebral Artery Stroke
- What is being tested?
- Piracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 571 participants
- Where
- 44 sitesin 15 countries
- Study dates
- Aug 1998to Jul 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
44 sites in 15 countries.
44 sites in 15 countries
Greece6 sites
251
Athens
252
Athens
302
Budapest
303
Budapest
305
Budapest
250
Thessaloniki
Turkey (Türkiye)4 sites
654
Edirne
650
Eskişehir
652
Istanbul
653
Istanbul
About this study
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
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.
Read the 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.
- Being tested
- Piracetam, Placebo
- Keywords
- Piracetam, Stroke, Aphasia, Acute, Cerebral, Ischemic, Nootropil
- Medical subject headings
- Stroke, Aphasia, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiracetamDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 84
Secondary outcomes (3)
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.
Measured: Day 84
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.
Measured: Day 84
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.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startAug 1998
- Primary completionJul 2001
- Study completionJul 2001
Why it stopped: This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischaemic Middle Cerebral Artery StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB S.A. - Pharma Sector
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883011
- Sponsor's protocol ID
- N09642
- Status last verified
- Aug 2013
- First submitted
- 18 Jun 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01883011
- Acronym / sponsor ID
- N09642
- Keywords
- Piracetam, Stroke, Aphasia, Acute, Cerebral, Ischemic, Nootropil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.
- Enrolment
- 571 participants (actual)
- Lead sponsor
- UCB S.A. - Pharma SectorIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piracetam | Experimental | Drug: PiracetamIV 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) |
| Placebo | Placebo comparator | Other: PlaceboIV 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piracetam | Drug | Piracetam |
| Placebo | Other | Placebo |
Primary outcome
The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84
Time frame: 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.
3 secondary outcomes
Middle Cerebral Artery infarction scale (MCA) score at Day 84
Time frame: Day 84
Total Barthel Index (BI) score at Day 84
Time frame: Day 84
Mini Mental State Examination (MMSE) score at Day 84
Time frame: Day 84
Results and safety
The study was stopped early (reason given: This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493
44 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piracetam in people with Acute Ischaemic Middle Cerebral Artery Stroke, run by UCB S.A. - Pharma Sector at 44 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Greece, Poland, Belgium, Germany, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84 (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.