NCT00133081

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

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

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 21, 2005

Status Verified

March 1, 2004

First QC Date

August 17, 2005

Last Update Submit

October 20, 2005

Conditions

Epilepsy

Keywords

epilepsyantiepileptic drugsside effectsquality of life

Outcome Measures

Primary Outcomes (1)

  • Complaints (questionnaire) at 7 and 13 months

Secondary Outcomes (1)

  • Quality of Life (Qolie-10) at 7 and 13 months

Interventions

All registered antiepileptic drugsDRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AZM

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Hospital Gooi-Noord

Blaricum, North Holland, 1250 CA, Netherlands

Location

MCRZ

Rotterdam, South Holland, 3007 AC, Netherlands

Location

MC Haaglanden

The Hague, South Holland, 2512 VA, Netherlands

Location

Oosterschelde Hospital

Goes, Zeeland, 4460 BB, Netherlands

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Cees A van Donselaar, MD PhD

    UMC Utrecht

    STUDY DIRECTOR

  • Sabine G Uijl, MSc

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Albert P Aldenkamp, PhD

    AZM Maastricht

    PRINCIPAL INVESTIGATOR

  • Cuno SP Uiterwaal, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 22, 2005

Study Start

October 1, 2002

Study Completion

August 1, 2006

Last Updated

October 21, 2005

Record last verified: 2004-03

Locations

NL(6)