EpilepsyNCT00319605
Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam
An observational study of Epilepsy, run by UCB Pharma at 54 sites in Spain.
Trial summary
Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam
- How many people
- 600 participants
- Where
- 54 sitesSpain
- Study dates
- Apr 2006to Jul 2006
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study populaton is defined. See Eligibility Criteria.
Who may be able to join
- Patients 16 years old or older diagnosed with partial epilepsy with or without generalization receiving levetiracetam oral solution for at least 28 days before the study
Who cannot join
- Patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Spain54 sites
Study site
A Coruña
Study site
Alcalá de Henares
Study site
Alcázar de San Juan
Study site
Alcorcón
Study site
Alicante
Study site
Alzira Valencia
Study site
Ávila
Study site
Badajoz
Study site
Barcelona
Study site
Benidorm
Study site
Cáceres
Study site
Cadz
Study site
Castellon
Study site
Cuenca
Study site
Elda
Study site
Eliana
Study site
Girona
Study site
Granada
Study site
Guadalajara
Study site
Hospitalet Del Llobregat
Study site
La Roca
Study site
Langreo
Study site
Las Palmas
Study site
Las Palmas de Gran Canaria
Study site
León
Study site
Lleida
Study site
Lorca Murcia
Study site
Lugo
Study site
Madrid
Study site
Málaga
Study site
Manzanares
Study site
Manzanares Ciudad Real
Study site
Mataró
Study site
Merida Badajoz
Study site
Móstoles
Study site
Murcia
Study site
Oviedo
Study site
Palencia
Study site
Palmar
Study site
Pamplona
Study site
Pontevedra
Study site
Puerto del Rosario
Study site
Sabadell
Study site
Salamanca
Study site
San Fernando
Study site
Santa Cruz de Tenerife
Study site
Seville
Study site
Terrassa
Study site
Teruel
Study site
Toledo
Study site
Valencia
Study site
Vigo Pontevedra
Study site
Zamora
Study site
Zaragoza
About this study
Official title: Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study)
Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.
- Conditions
- Epilepsy
- Being tested
- Levetiracetam
- Keywords
- Cross sectional study, acceptability, levetiracetam, oral solution, Keppra
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2006
- Study completionJul 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Marin Muñoz, MD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319605
- Sponsor's protocol ID
- N01242
- Status last verified
- May 2012
- First submitted
- 28 Apr 2006
- Last updated
- 25 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study)
- ClinicalTrials.gov ID
- NCT00319605
- Acronym / sponsor ID
- N01242
- Conditions
- Epilepsy
- Keywords
- Cross sectional study, acceptability, levetiracetam, oral solution, Keppra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Apr 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.
Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study populaton is defined. See Eligibility Criteria.
Key inclusion criteria (1 listed)
- Patients 16 years old or older diagnosed with partial epilepsy with or without generalization receiving levetiracetam oral solution for at least 28 days before the study
Key exclusion criteria (1 listed)
- Patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study
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 |
|---|---|---|
| Levetiracetam | Drug | – |
Primary outcome
Not reported in the source record.
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 25 May 2012.
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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.
Helena Marin Muñoz, MD study director
UCB Pharma
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by UCB Pharma at 54 sites in Spain.
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 1 inclusion and 1 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Spain. 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.
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 25 May 2012; AzTrials last refreshed its copy on 1 Nov 2026.