NCT00302991

Brief Summary

Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

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

March 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

1.6 years

First QC Date

March 13, 2006

Last Update Submit

January 29, 2008

Conditions

Epilepsy

Keywords

Observationalcross-sectionalhealth-related quality of lifeadverse effectsBaker´s AEP scale validationepilepsy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months

You may not qualify if:

  • Symptomatic epilepsy due to malignant brain tumour or progressive brain disease.
  • Confirmed diagnosis of a concomitant chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barcelona, Spain

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • UCB Clinical Trial M. Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

ES(1)