Partial Seizure DisorderPhase 3NCT00067431
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
A Phase 3 study testing Divalproex Sodium (Depakote® Sprinkle Capsules) in people with Partial Seizure Disorder, run by Abbott at 7 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Partial Seizure Disorder
- What is being tested?
- Divalproex Sodium (Depakote® Sprinkle Capsules)
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2003to not given
- Phase
- Phase 3
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
- Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
- 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
- On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
- Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
- History of at least 4 partial seizures/month in 2 months prior to screening
- Parent/caregiver is able to keep an accurate seizure diary
Who cannot join
- History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
- Has had status epilepticus in the past 6 months
- Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
- Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
- Has platelet count less than or equal to 100,000/mcL
- Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
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- Requires anticoagulant drug therapy
- Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
- Receiving systemic chemotherapy
- Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
- Has been on ketogenic diet within 30 days prior to screening
- Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rainbow Babies Children's Hospital
Cleveland, Ohio, 44106
University Hospital of Cleveland
Cleveland, Ohio
PCTI / Children's Hospital
Columbus, Ohio, 43205
Primary Physician's Research
Pittsburgh, Pennsylvania
Virginia Commonwealth University
Richmond, Virginia, 23298-0211
Texas Association of Pediatric Neurology, PA
San Antonio, Texas, 78258
Pediatric Epilepsy & Neurology Specialist
Tampa, Florida, 33607
About this study
The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.
- Conditions
- Partial Seizure Disorder
- Being tested
- Divalproex Sodium (Depakote® Sprinkle Capsules)
- Keywords
- Partial Seizures
- Medical subject headings
- Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium (Depakote® Sprinkle Capsules)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the 4-week partial seizure rate
Secondary outcomes (3)
Adverse events
Laboratory data
Vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2003 (estimated)
- Study startJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Seizure DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laura Redden, M.D., Ph.D., Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067431
- Sponsor's protocol ID
- M02-552
- Status last verified
- Aug 2006
- First submitted
- 19 Aug 2003
- Last updated
- 4 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
- ClinicalTrials.gov ID
- NCT00067431
- Acronym / sponsor ID
- M02-552
- Conditions
- Partial Seizure Disorder
- Keywords
- Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- First posted
- 20 Aug 2003 (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 purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
- Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
- 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
- On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
- Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
Key exclusion criteria (12 listed)
- History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
- Has had status epilepticus in the past 6 months
- Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
- Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
- Has platelet count less than or equal to 100,000/mcL
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 |
|---|---|---|
| Divalproex Sodium (Depakote® Sprinkle Capsules) | Drug | – |
Primary outcome
Change from baseline in the 4-week partial seizure rate
3 secondary outcomes
Adverse events
Laboratory data
Vital signs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2006.
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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.
Laura Redden, M.D., Ph.D. study director
Medical Director
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divalproex Sodium (Depakote® Sprinkle Capsules) in people with Partial Seizure Disorder, run by Abbott at 7 sites 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 7 inclusion and 12 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 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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. 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?
Change from baseline in the 4-week partial seizure rate. 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 4 Aug 2006.