EpilepsyPhase 4NCT00133081
Study to Improve the Treatment of Epilepsy (SITE)
A Phase 4 study testing All registered antiepileptic drugs in people with Epilepsy, run by UMC Utrecht at 6 sites in Netherlands.
Trial summary
The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- All registered antiepileptic drugs
- How many people
- 255 participants
- Where
- 6 sitesNetherlands
- Study dates
- Oct 2002to Aug 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Treatment: antiepileptic drugs for epilepsy
- No change in medication during last 6 months
- No obvious clinical reason to change medication immediately
Who cannot join
- Concurrent disease or disorder that might interfere with the conduct of the study
- Inability to comply to the protocol
- Impaired intellectual functioning, leading to inability to comply to the protocol and complete the necessary questionnaires
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Hospital Gooi-Noord
Blaricum, North Holland, 1250 CA
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Oosterschelde Hospital
Goes, Zeeland, 4460 BB
AZM
Maastricht, Limburg, 6202 AZ
MCRZ
Rotterdam, South Holland, 3007 AC
MC Haaglanden
The Hague, South Holland, 2512 VA
About this study
Official title: Study to Improve the Treatment of Epilepsy (SITE). A Randomized Study Comparing Adjustment of Treatment to Reduce Side Effects of Antiepileptic Drugs With Continuing Treatment Unchanged
The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs.
Read the detailed description
Background. The aim of the treatment with antiepileptic drugs (AEDs) is to achieve seizure freedom without causing side effects. Assessment of side effects is difficult. They may start insidiously, the patient may not associate certain complaints with the use of AEDs, or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department. We know from clinical trials that side effects occur in a substantial group of patients. We do not know whether we deal with this possible complication in an adequate way in clinical practice.
Study objective. To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life.
Study design. A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged. Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy.
Patients who do not report relevant side effects will be followed for 13 months (arm A) in which two visits are scheduled, after 7 and 13 months respectively.
The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate (arm B) or to ignore the results of the questionnaire and continue treatment unchanged (arm C). Investigations will be repeated in both groups after 7 and 13 months after the initial visit.
- Conditions
- Epilepsy
- Being tested
- All registered antiepileptic drugs
- Keywords
- epilepsy, antiepileptic drugs, side effects, quality of life
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All registered antiepileptic drugsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complaints (questionnaire) at 7 and 13 months
Secondary outcomes (1)
Quality of Life (Qolie-10) at 7 and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startOct 2002
- Study completionAug 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Cees A van Donselaar, MD PhD, Study director, UMC UtrechtSabine G Uijl, MSc, Principal investigator, UMC UtrechtAlbert P Aldenkamp, PhD, Principal investigator, AZM MaastrichtCuno SP Uiterwaal, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133081
- Sponsor's protocol ID
- SITE
- Status last verified
- Mar 2004
- First submitted
- 17 Aug 2005
- Last updated
- 21 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Improve the Treatment of Epilepsy (SITE). A Randomized Study Comparing Adjustment of Treatment to Reduce Side Effects of Antiepileptic Drugs With Continuing Treatment Unchanged
- ClinicalTrials.gov ID
- NCT00133081
- Acronym / sponsor ID
- SITE
- Conditions
- Epilepsy
- Keywords
- epilepsy, antiepileptic drugs, side effects, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2002
- Study completion
- Aug 2006
- First posted
- 22 Aug 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 this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs.
Detailed description
Background. The aim of the treatment with antiepileptic drugs (AEDs) is to achieve seizure freedom without causing side effects. Assessment of side effects is difficult. They may start insidiously, the patient may not associate certain complaints with the use of AEDs, or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department. We know from clinical trials that side effects occur in a substantial group of patients. We do not know whether we deal with this possible complication in an adequate way in clinical practice.
Study objective. To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life.
Study design. A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged. Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy.
Patients who do not report relevant side effects will be followed for 13 months (arm A) in which two visits are scheduled, after 7 and 13 months respectively.
The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate (arm B) or to ignore the results of the questionnaire and continue treatment unchanged (arm C). Investigations will be repeated in both groups after 7 and 13 months after the initial visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Treatment: antiepileptic drugs for epilepsy
- No change in medication during last 6 months
- No obvious clinical reason to change medication immediately
Key exclusion criteria (3 listed)
- Concurrent disease or disorder that might interfere with the conduct of the study
- Inability to comply to the protocol
- Impaired intellectual functioning, leading to inability to comply to the protocol and complete the necessary questionnaires
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 |
|---|---|---|
| All registered antiepileptic drugs | Drug | – |
Primary outcome
Complaints (questionnaire) at 7 and 13 months
1 secondary outcome
Quality of Life (Qolie-10) at 7 and 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2005.
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
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.
Cees A van Donselaar, MD PhD study director
UMC Utrecht
Sabine G Uijl, MSc principal investigator
UMC Utrecht
Albert P Aldenkamp, PhD principal investigator
AZM Maastricht
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing All registered antiepileptic drugs in people with Epilepsy, run by UMC Utrecht at 6 sites in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Complaints (questionnaire) at 7 and 13 months. 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 Oct 2005.