Status:
COMPLETED
Standardized Educational Plan for Epilepsy Patients With Comorbidities
Lead Sponsor:
San Gerardo Hospital
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age....
Detailed Description
OBJECTIVES OF THE STUDY The primary objective of the study is to verify whether or not a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult p...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Presence of one or more concurrent clinical conditions requiring chronic treatment (ie, daily treatment lasting one month or longer)
- At least one clinically relevant adverse event attributable to the present treatment(s) and/or a clinically relevant drug interaction; for the purposes of this study, a clinically relevant adverse event is any symptom and/or clinical and/or laboratory sign requiring treatment change; a clinically relevant drug interaction is an interaction requiring active monitoring and/or treatment change
- The treatment schedule can be modified to eliminate adverse event(s) and/or risky drug interactions; the decision to modify the treatment is left to the caring physician's judgment
Exclusion
- Age younger than 18 years
- Absence of concurrent chronic treatments
- Presence of polytherapy with AEDs unassociated to treatments for concurrent (non-epileptic) disorders
- The treatment schedule cannot be changed even at the presence of clinically relevant adverse events
- Patient is unable to understand or comply with an educational plan; the application of this exclusion criterion is left to the caring physician's judgment
- Patient or caregiver is unwilling to release a written informed consent
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT01804322
Start Date
February 1 2009
End Date
September 1 2012
Last Update
March 6 2013
Active Locations (1)
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1
Azienda Ospedaliera San Gerardo, Central Contact (9 recruting centers)
Monza, MB, Italy, 20900