Pediatric EpilepsyPhase 2NCT00646711
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
A Phase 2 study testing Depakote Delayed-Release/Depakote Sprinkle and Depakote ER in people with Pediatric Epilepsy, run by Abbott at 1 site in United States.
Trial summary
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Epilepsy
- What is being tested?
- Depakote Delayed-Release/Depakote Sprinkle and Depakote ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2003
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator.
- Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization.
- Minimum body weight of 37 lbs.
Who cannot join
- Six-month history of drug or alcohol abuse.
- Status epilepticus within 6 months prior to screening.
- Abnormal platelet or ALT/AST levels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
- Conditions
- Pediatric Epilepsy
- Being tested
- Depakote Delayed-Release/Depakote Sprinkle, Depakote ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depakote Delayed-Release/Depakote SprinkleDrug
Also called ABT-711, Depakote DR, Depakote Sprinkle, divalproex sodium
Administered according to the subject's usual regimen.
Depakote ERDrug
Also called ABT-711, Depakote Extended Release, divalproex sodium
Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group I | Experimental | Depakote Delayed Release/Depakote Sprinkle Receives: Drug: Depakote Delayed-Release/Depakote Sprinkle |
| Sequence Group II | Experimental | Depakote ER Receives: Drug: Depakote ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures
Measured: 2 weeks
Number of Adverse Events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startFeb 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646711
- Sponsor's protocol ID
- M02-461
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT00646711
- Acronym / sponsor ID
- M02-461
- Conditions
- Pediatric Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 28 Mar 2008 (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.
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence Group I | Experimental | Drug: Depakote Delayed-Release/Depakote SprinkleDepakote Delayed Release/Depakote Sprinkle |
| Sequence Group II | Experimental | Drug: Depakote ERDepakote ER |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator.
- Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization.
- Minimum body weight of 37 lbs.
Key exclusion criteria (3 listed)
- Six-month history of drug or alcohol abuse.
- Status epilepticus within 6 months prior to screening.
- Abnormal platelet or ALT/AST levels.
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 |
|---|---|---|
| Depakote Delayed-Release/Depakote SprinkleAlso: ABT-711, Depakote DR, Depakote Sprinkle, divalproex sodiumAdministered according to the subject's usual regimen. | Drug | Sequence Group I |
| Depakote ERAlso: ABT-711, Depakote Extended Release, divalproex sodiumDose converted to 8-20% higher than Depakote DR or Depakote Sprinkle. | Drug | Sequence Group II |
Primary outcome
Number of seizures
Time frame: 2 weeks
Number of Adverse Events
Time frame: 2 weeks
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 28 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depakote Delayed-Release/Depakote Sprinkle and Depakote ER in people with Pediatric Epilepsy, run by Abbott 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: finished, as of the sponsor's last update on 28 Mar 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 2 weeks). The study lists 2 primary outcomes in all. 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 28 Mar 2008.