Trial record 6 of 129 for:    Open Studies | "Seizures"

A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)

This study is currently recruiting participants.
Verified April 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01830400
First received: April 8, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician has decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals. Patients in this study will be assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.


Condition Intervention
Partial Onset Seizures
Drug: Eslicarbazepine Acetate tablets

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Overall Seizure Frequency after 3 and 6 months from Baseline [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ESL.


Estimated Enrollment: 800
Study Start Date: April 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eslicarbazepine Acetate tablets Drug: Eslicarbazepine Acetate tablets
The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommends a starting dose of 400 mg once-daily (QD) which should be increased to 800 mg QD after one or two weeks. Based on individual response, the dose may be increased to 1200 mg QD. Treatment decisions will be made by clinicians in agreement with the participant, and will be independent of participation in the study.
Other Name: ESL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Normal clinical practice setting/ centre.

Criteria

Inclusion Criteria:

  • The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
  • Patients treated with one drug licensed for monotherapy in partial onset seizures
  • Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with a current monotherapy and it is in the patient's best interest to be prescribed adjunctive ESL
  • Patient was prescribed ESL no longer than 2 weeks before the baseline
  • Treatment with ESL has to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
  • Aged 18 years or older
  • Signed written informed consent

Exclusion Criteria:

  • Patients that have started ESL outside the approved SPC at enrolment
  • Simultaneous participation in an interventional clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830400

Contacts
Contact: Makarand Bagul, Dr. + 44 845 676 1342 Makarand_Bagul@eisai.net

  Show 103 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Martin Holtkamp, Dr. Klinische und Experimentelle Epileptologie
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01830400     History of Changes
Other Study ID Numbers: E2093-E044-404
Study First Received: April 8, 2013
Last Updated: April 11, 2013
Health Authority: Germany: Institutional Review Board
Sweden: Institutional Review Board
UK: Institutional Review Board
Ireland: Institutional Review Board
France: Conseil National de l'Ordre des Médecins (CNOM)
Denmark: Danish Medicines Agency
Czech Republic: SUKL STATNI USTAV PRO KONTROLU LECIV

Keywords provided by Eisai Inc.:
ESL
Partial onset seizures
Retention Rate
Seizure Control
Antiepileptic
Secondary Generalisation

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014