NCT00319605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

Geographic Reach
1 country

54 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

3 months

First QC Date

April 28, 2006

Last Update Submit

May 24, 2012

Conditions

Epilepsy

Keywords

Cross sectional studyacceptabilitylevetiracetamoral solutionKeppra

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study populaton is defined. See Eligibility Criteria.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (54)

Unknown Facility

A Coruña, Spain

Location

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Alcalá de Henares, Spain

Location

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Alcázar de San Juan, Spain

Location

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Alcorcón, Spain

Location

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Alicante, Spain

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Alzira Valencia, Spain

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Ávila, Spain

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Badajoz, Spain

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Barcelona, Spain

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Benidorm, Spain

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Cadz, Spain

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Castellon, Spain

Location

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Cáceres, Spain

Location

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Cuenca, Spain

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Elda, Spain

Location

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Eliana, Spain

Location

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Girona, Spain

Location

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Granada, Spain

Location

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Guadalajara, Spain

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Hospitalet Del Llobregat, Spain

Location

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La Roca, Spain

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Langreo, Spain

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Las Palmas, Spain

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Las Palmas de Gran Canaria, Spain

Location

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León, Spain

Location

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Lleida, Spain

Location

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Lorca Murcia, Spain

Location

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Lugo, Spain

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Madrid, Spain

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Manzanares, Spain

Location

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Manzanares Ciudad Real, Spain

Location

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Mataró, Spain

Location

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Málaga, Spain

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Merida Badajoz, Spain

Location

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Móstoles, Spain

Location

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Murcia, Spain

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Oviedo, Spain

Location

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Palencia, Spain

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Palmar, Spain

Location

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Pamplona, Spain

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Pontevedra, Spain

Location

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Puerto del Rosario, Spain

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Sabadell, Spain

Location

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Salamanca, Spain

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San Fernando, Spain

Location

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Santa Cruz de Tenerife, Spain

Location

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Seville, Spain

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Terrassa, Spain

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Teruel, Spain

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Toledo, Spain

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Valencia, Spain

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Vigo Pontevedra, Spain

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Zamora, Spain

Location

Unknown Facility

Zaragoza, Spain

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Helena Marin Muñoz, MD

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

ES(54)