Post Cerebral HemorrhagePhase 4NCT01115959
Seizures Post Intracerebral Hemorrhage
A Phase 4 study testing valproic acid in people with Post Cerebral Hemorrhage, run by Wolfson Medical Center.
Trial summary
This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Cerebral Hemorrhage
- What is being tested?
- valproic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cerebral hemorrhage spontaneous
Who cannot join
- early seizures
About this study
Official title: Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?
This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.
- Conditions
- Post Cerebral Hemorrhage
- Being tested
- valproic acid, placebo bid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valproic acidDrug
treatment of 1 month dosage of 400 mg BID
placebo bidDrug
| Study group | Role | What they receive |
|---|---|---|
| valproic acid | Active comparator | Valproic acid given orally 400mg twice daily Receives: Drug: valproic acid; Drug: placebo bid |
| placebo | Placebo comparator | Placebo twice daily for one month Receives: Drug: placebo bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of seizures
Measured: study drug for 1 month and 1 year follow up
Secondary outcomes (1)
neurological outcome NIHSS
Measured: during 1 month study drug and 1 year post follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startFeb 2003
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Cerebral HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Yair Lampl, Wolfson Medical Center
- Investigators
- ronit gilad, md, Principal investigator, E Wolfson med centerronit gilad, md, Principal investigator, E wofson med center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115959
- Sponsor's protocol ID
- 001
- Status last verified
- May 2010
- First submitted
- 2 May 2010
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?
- ClinicalTrials.gov ID
- NCT01115959
- Acronym / sponsor ID
- 001
- Conditions
- Post Cerebral Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Feb 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 May 2010 (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.
This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valproic acid | Active comparator | Drug: valproic acid, Drug: placebo bidValproic acid given orally 400mg twice daily |
| placebo | Placebo comparator | Drug: placebo bidPlacebo twice daily for one month |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cerebral hemorrhage spontaneous
Key exclusion criteria (1 listed)
- early seizures
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 |
|---|---|---|
| valproic acidtreatment of 1 month dosage of 400 mg BID | Drug | valproic acid |
| placebo bid | Drug | placebo, valproic acid |
Primary outcome
number of seizures
Time frame: study drug for 1 month and 1 year follow up
1 secondary outcome
neurological outcome NIHSS
Time frame: during 1 month study drug and 1 year post follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
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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.
ronit gilad, md principal investigator
E Wolfson med center
ronit gilad, md principal investigator
E wofson med center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valproic acid in people with Post Cerebral Hemorrhage, run by Wolfson Medical Center.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of seizures (time frame: study drug for 1 month and 1 year follow up). 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 12 Jun 2014.