EpilepsyNCT00381537
Prediction of Childhood Epilepsy Outcome in Bangladesh
A study testing phenobarbitone and carbamazepine in people with Epilepsy, run by Institute of Child Health at 2 sites in 2 countries.
Trial summary
Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- phenobarbitone and carbamazepine
- How many people
- 92 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Active epilepsy
- Aged 2-15 years
Who cannot join
- Excluded absence
- Myoclonic and malignant epilepsy syndromes
- Major motor and cognitive impairments
- Those currently receiving antiepilepsy drugs.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Bangladesh1 site
Children's Hospital Dhaka (Shishu) Bangladesh.
Sher-e-Bangla Nagar, Dhaka 1207
About this study
Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.
- Conditions
- Epilepsy
- Being tested
- phenobarbitone, carbamazepine
- Keywords
- childhood epilepsy, Active childhood epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenobarbitoneDrug
carbamazepineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Brian Neville, Professor, Principal investigator, Institute of Child HealthSelina Banu, Dr, Principal investigator, Children's Hospital Dhaka (Shishu) Bangladesh.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381537
- Sponsor's protocol ID
- 99NR58
- Status last verified
- Dec 2006
- First submitted
- 27 Sep 2006
- Last updated
- 25 Dec 2006
- Results posted
- No
Publications
Banu SH, Jahan M, Koli UK, Ferdousi S, Khan NZ, Neville B. Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial. BMJ. 2007 Jun 9;334(7605):1207. doi: 10.1136/bmj.39022.436389.BE. Epub 2006 Dec 4.
PubMed 17145735
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Childhood Epilepsy Outcome in Bangladesh
- ClinicalTrials.gov ID
- NCT00381537
- Acronym / sponsor ID
- 99NR58
- Conditions
- Epilepsy
- Keywords
- childhood epilepsy, Active childhood epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- First posted
- 28 Sep 2006 (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.
Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Active epilepsy
- Aged 2-15 years
Key exclusion criteria (4 listed)
- Excluded absence
- Myoclonic and malignant epilepsy syndromes
- Major motor and cognitive impairments
- Those currently receiving antiepilepsy drugs.
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 |
|---|---|---|
| phenobarbitone | Drug | – |
| carbamazepine | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Dec 2006.
- Derived from this study: PubMed 17145735Banu SH, Jahan M, Koli UK, Ferdousi S, Khan NZ, Neville B. Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial. BMJ. 2007 Jun 9;334(7605):1207. doi: 10.1136/bmj.39022.436389.BE. Epub 2006 Dec 4.
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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.
Brian Neville, Professor principal investigator
Institute of Child Health
Selina Banu, Dr principal investigator
Children's Hospital Dhaka (Shishu) Bangladesh.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phenobarbitone and carbamazepine in people with Epilepsy, run by Institute of Child Health at 2 sites in 2 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 2 inclusion and 4 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 25 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, United Kingdom. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381537, which also lists 1 linked publication.
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 25 Dec 2006.