EpilepsyNCT00870688
Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
An observational study of Epilepsy, run by Desitin Arzneimittel GmbH.
Trial summary
Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- sodium valproate
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2006
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: community sample outpatients
Who may be able to join
- age of 12 years and above
- epilepsy patients
- indication to initiation / conversion to valproate sustained release minitablets once daily
Who cannot join
- contraindication to valproate use
- no indication for conversion to valproate sustained release minitablets once daily
About this study
Official title: Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening
Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.
A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.
- Conditions
- Epilepsy
- Being tested
- sodium valproate
- Keywords
- valproate, epilepsy, compliance, sustained released minitablet, Orfiril long
- Medical subject headings
- Epilepsy, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium valproateDrug
Also called Orfiril (R) long
valproate sustained release minitablets, once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | epilepsy patients Receives: Drug: sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Measured: 7 weeks
Number of Seizures Within 7 Weeks
Measured: 7 weeks
Secondary outcomes (1)
Data About Efficacy, Safety and Compliance
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870688
- Sponsor's protocol ID
- VPA 044/K
- Status last verified
- Feb 2009
- First submitted
- 9 Jan 2009
- Last updated
- 20 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening
- ClinicalTrials.gov ID
- NCT00870688
- Acronym / sponsor ID
- VPA 044/K
- Conditions
- Epilepsy
- Keywords
- valproate, epilepsy, compliance, sustained released minitablet, Orfiril long
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Posted 27 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.
A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: sodium valproateepilepsy patients |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample outpatients
Key inclusion criteria (3 listed)
- age of 12 years and above
- epilepsy patients
- indication to initiation / conversion to valproate sustained release minitablets once daily
Key exclusion criteria (2 listed)
- contraindication to valproate use
- no indication for conversion to valproate sustained release minitablets once daily
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 |
|---|---|---|
| sodium valproateAlso: Orfiril (R) longvalproate sustained release minitablets, once daily. | Drug | 1 |
Primary outcome
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Time frame: 7 weeks
Number of Seizures Within 7 Weeks
Time frame: 7 weeks
1 secondary outcome
Data About Efficacy, Safety and Compliance
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Desitin Arzneimittel GmbH.
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 2 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 20 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily (time frame: 7 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 20 May 2009.