AphasiaPhase 1NCT00227461
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
A Phase 1 study testing Wait first, then levetiracetam and Levetiracetam first, then wait in people with Aphasia and Stroke, run by Kessler Foundation at 1 site in United States.
Trial summary
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Wait first, then levetiracetam and Levetiracetam first, then wait
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke
- Aphasia
- Can give consent
Who cannot join
- Renal failure
- Pregnancy
- Other neurological condition
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.
Read the detailed description
In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.
- Being tested
- Wait first, then levetiracetam, Levetiracetam first, then wait
- Keywords
- Aphasia, Stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wait first, then levetiracetamDrug
Also called Keppra
Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.
Levetiracetam first, then waitDrug
Also called Keppra
subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
| Study group | Role | What they receive |
|---|---|---|
| Wait control | Other | Levitiracetam is started after a delay, with dosage and administration as described below. Receives: Drug: Levetiracetam first, then wait |
| Treatment first | Experimental | Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below. Receives: Drug: Wait first, then levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech and language assessment
Measured: 6 months - 1year
Secondary outcomes (1)
Memory assessment
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, A. M. Barrett, MD, Kessler Foundation
- Investigators
- A.M. Barrett, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227461
- Sponsor's protocol ID
- AMBarrett1
- Other IDs
- none applicable
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2005
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
- ClinicalTrials.gov ID
- NCT00227461
- Acronym / sponsor ID
- AMBarrett1
- Keywords
- Aphasia, Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Sep 2005 (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 study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.
Detailed description
In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait control | Other | Drug: Levetiracetam first, then waitLevitiracetam is started after a delay, with dosage and administration as described below. |
| Treatment first | Experimental | Drug: Wait first, then levetiracetamLevitiracetam is started immediately after baseline data is collected; dosage and administration as described below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke
- Aphasia
- Can give consent
Key exclusion criteria (3 listed)
- Renal failure
- Pregnancy
- Other neurological condition
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 |
|---|---|---|
| Wait first, then levetiracetamAlso: KeppraLevetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days. | Drug | Treatment first |
| Levetiracetam first, then waitAlso: Kepprasubjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design | Drug | Wait control |
Primary outcome
Speech and language assessment
Time frame: 6 months - 1year
1 secondary outcome
Memory assessment
Time frame: 6 months to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Related trials for Aphasia
Not yet recruiting
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Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
A.M. Barrett, MD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wait first, then levetiracetam and Levetiracetam first, then wait in people with Aphasia and Stroke, run by Kessler Foundation at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Speech and language assessment (time frame: 6 months - 1year). 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 17 Feb 2021.