Partial SeizuresPhase 3NCT00102713
A Study for Treatment of Partial Seizures in Children
A Phase 3 study testing Divalproex Sodium (Depakote Sprinkle Capsules) in people with Partial Seizures, run by Abbott at 10 sites in United States.
Trial summary
The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Partial Seizures
- What is being tested?
- Divalproex Sodium (Depakote Sprinkle Capsules)
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2005to 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 3:
- EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
- If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
- If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
- Subject weighs at least 15 kg (33 lbs).
- Parent/caregiver is able to keep an accurate seizure diary.
Who cannot join
- Has had status epilepticus in the past 3 months prior to Screening
- Has a history of any of: 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
- Requires anticoagulant drug therapy
Show all 11Show fewer
- Receiving systemic chemotherapy
- Requires treatment with aspirin
- Subject is pregnant
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Akron Children's Hospital
Akron, Ohio, 44308 1062
Child Neurology Associates, P.C.
Atlanta, Georgia
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Richard V. Colan, M.D., S.C.
Milwaukee, Wisconsin, 53226
Monarch Medical Research
Norfolk, Virginia, 23510
Neurology Clinic, P.C.
Northport, Alabama
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0211
Texas Association of Pediatric Neurology, P.A.
San Antonio, Texas
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida
About this study
Official title: An Open Label Study for Treatment of Partial Seizures in Children
The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
- Conditions
- Partial Seizures
- Being tested
- Divalproex Sodium (Depakote Sprinkle Capsules)
- Keywords
- Partial Seizures
- Medical subject headings
- 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.
Partial Seizure Rate at Week 4
Secondary outcomes (9)
Adverse Events
WASI
WPPSI-III
BASC
UKU-Neurologic Assessment
Vital Signs
Clinical Laboratory Assessments
ECG
PK analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial SeizuresStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information 800-633-9110, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102713
- Sponsor's protocol ID
- M04-714
- Status last verified
- May 2007
- First submitted
- 1 Feb 2005
- Last updated
- 21 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study for Treatment of Partial Seizures in Children
- ClinicalTrials.gov ID
- NCT00102713
- Acronym / sponsor ID
- M04-714
- Conditions
- Partial Seizures
- Keywords
- Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- First posted
- 2 Feb 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 purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 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 3:
- Subject weighs at least 15 kg (33 lbs).
- Parent/caregiver is able to keep an accurate seizure diary.
Key exclusion criteria (11 listed)
- Has had status epilepticus in the past 3 months prior to Screening
- Has a history of any of: 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
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
Partial Seizure Rate at Week 4
9 secondary outcomes
Adverse Events
WASI
WPPSI-III
BASC
UKU-Neurologic Assessment
Vital Signs
Clinical Laboratory Assessments
ECG
PK analysis
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 21 May 2007.
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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.
Global Medical Information 800-633-9110 study director
Abbott
10 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 Seizures, run by Abbott at 10 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 8 inclusion and 11 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 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Partial Seizure Rate at Week 4. 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 21 May 2007; AzTrials last refreshed its copy on 7 Nov 2026.