EpilepsyNCT00347152
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
A study testing Divalproex in people with Epilepsy, run by University of Kansas at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Divalproex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients currently taking divalproex direct release for any seizure and/or behavior disorder
- patients with intellectual disability
- other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected
Who cannot join
- patients with a recent history of status epilepticus in the past 6 months
- seizures in the past 3 months
- patients with acute illness requiring changes in concurrent drugs
- patients unwilling to change from their present direct release divalproex to divalproex extended release
- patients that do not have a reliable caregiver
- patients with lack of verbal expressive speech
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Overnight Versus Progressive Conversion of Multiple Daily Dose Enteric-Coated Divalproex to Once-Daily Divalproex Extended Release: Which Strategy is Better Tolerated by Patients With Intellectual Disabilities?
The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
Read the detailed description
Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
- Conditions
- Epilepsy
- Being tested
- Divalproex
- Keywords
- Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy
- Medical subject headings
- Epilepsy, Intellectual Disability, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivalproexDrug
Also called Depakote
Divalproex, 8-20% taper
DivalproexDrug
Also called Depakote
Divalproex, 8-20% taper
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Slow Progressive Divalproex DR to Divalproex ER switch Receives: Drug: Divalproex |
| 1 | Active comparator | Immediate, Progressive Divalproex DR to Divalproex ER switch Receives: Drug: Divalproex |
What is being measured
The primary outcome is the main question the study is designed to answer.
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects)
Measured: Baseline to day +8
Secondary outcomes (3)
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
Measured: Baseline to day + 8
total valproic acid serum levels (trough of pre-dose measurements)
Measured: Prior to conversion, 1 week post conversion
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Measured: Prior to and one week post conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Jessica Hellings, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347152
- Sponsor's protocol ID
- 10399
- Status last verified
- Sep 2008
- First submitted
- 30 Jun 2006
- Last updated
- 12 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Versus Progressive Conversion of Multiple Daily Dose Enteric-Coated Divalproex to Once-Daily Divalproex Extended Release: Which Strategy is Better Tolerated by Patients With Intellectual Disabilities?
- ClinicalTrials.gov ID
- NCT00347152
- Acronym / sponsor ID
- 10399
- Conditions
- Epilepsy
- Keywords
- Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Jul 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.
The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
Detailed description
Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: DivalproexSlow Progressive Divalproex DR to Divalproex ER switch |
| 1 | Active comparator | Drug: DivalproexImmediate, Progressive Divalproex DR to Divalproex ER switch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients currently taking divalproex direct release for any seizure and/or behavior disorder
- patients with intellectual disability
- other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected
Key exclusion criteria (6 listed)
- patients with a recent history of status epilepticus in the past 6 months
- seizures in the past 3 months
- patients with acute illness requiring changes in concurrent drugs
- patients unwilling to change from their present direct release divalproex to divalproex extended release
- patients that do not have a reliable caregiver
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 |
|---|---|---|
| DivalproexAlso: DepakoteDivalproex, 8-20% taper | Drug | 2 |
| DivalproexAlso: DepakoteDivalproex, 8-20% taper | Drug | 1 |
Primary outcome
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects)
Time frame: Baseline to day +8
3 secondary outcomes
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
Time frame: Baseline to day + 8
total valproic acid serum levels (trough of pre-dose measurements)
Time frame: Prior to conversion, 1 week post conversion
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Time frame: Prior to and one week post conversion
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 Sep 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.
Jessica Hellings, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Divalproex in people with Epilepsy, run by University of Kansas 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 6 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 Sep 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.
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?
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects) (time frame: Baseline to day +8). 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 Sep 2008.