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Outcome Study in Refractory Epilepsy (SOPHIE) (SOPHIE)

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ClinicalTrials.gov Identifier: NCT03939507
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
University of Catanzaro
University of Bologna
Information provided by (Responsible Party):
University of Pavia

Brief Summary:

Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment. Several new AEDs have been introduced in recent years, but their impact on the long-term outcome in these patients has been inadequately explored. Preliminary data from the U.S. suggests that using a standardize toll to quantitate adverse AED effects can improve outcome, but the general applicability of these findings is unclear.

Objectives: 1) To assess prospectively AED utilization patterns in patients with refractory epilepsy ; 2) to assess how such treatments and other variables correlated with seizure control, adverse effects, and QoL in these patients; 3) to establish the impact of a standardized evaluation of adverse effects on clinical outcome.

Methods: The project included a core observational study and a randomized intervention in a subcohort.

In the core (observational) study, 1,000 consecutive refractory epilepsy patients were enrolled and followed-up prospectively at 10 centres in Italy. The following parameters were recorded at 0 (entry), 6, 12 and 18 months: (i) drug therapy; (ii) seizure frequency; (iii) adverse events based on medical examination and non-structured interview; (iii) treatment costs and, (iv) for patients above age 16, standardized questionnaires for adverse effects (AEP), depressive symptoms (Becks Depression Scale, BDS), QoL (QOLIE-31) and clinical global impression (CGI). The primary outcome (changes in QOLIE-31 scores) will be related to the other variables measured.

In the randomized intervention, the subcohort meeting specific eligibility criteria (age >16 years, no progressive disorder, AEP score>=45 ) was randomized to two groups. In the intervention group, AEP score results were made available to the physician at each visit, while in the other group AEP scores were only made available at the end of follow-up. Primary outcome were changes in AEP score.


Condition or disease Intervention/treatment Phase
Epilepsy Other: AEP score available to the treating physician Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the randomized assessment, patients meeting eligibility were randomized to two groups. In the intervention group, AEP score results were made available to the treating physician at each assessment visit, while in the other group AEP scores were only made available at the end of follow-up.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Prospective Study on Long-term Outcome and Potential Usefulness fo an Intervention Aimed at Reducing Adverse Effects in Patients With Refractory Epilepsy
Actual Study Start Date : November 6, 2006
Actual Primary Completion Date : July 16, 2009
Actual Study Completion Date : July 16, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Intervention group
AEP score results were made available to the treating physician at each assessment visit.
Other: AEP score available to the treating physician
the treating physician knew the AEP score results

No Intervention: Control group
AEP scores were only made available at the end of follow-up.



Primary Outcome Measures :
  1. Quality Of Life In Epilepsy (QOLIE)-31 global score [ Time Frame: Month 18 ]
    The change in QOLIE-31 global score (final visit vs initial visit). QOLIE-31 is a widely used epilepsy-specific questionnaire

  2. Adverse Events Profiles (AEP) score [ Time Frame: Month 18 ]
    The change in AEP score (final visit vs initial visit). The epilepsy-specific validated scale was used. Higher values represent a worse outcome.


Secondary Outcome Measures :
  1. Retention patients and AntiEpileptic Drugs (AEDs) added/substituted [ Time Frame: month 6, 12, 18 ]
    Retention of patients on each of the AEDs added/substituted

  2. Percentage of patients seizure free on each of the AEDs added/substituted [ Time Frame: month 6, 12 ]
    Percentage of patients free achieving 6- and 12-month seizure remission on each of the AEDs added/substituted

  3. Percentage of patients with 50% seizure reduction on each of the AEDs added/substituted [ Time Frame: month 6 ]
    Percentage of patients with 50% seizure reduction over 6 months (vs 3-month period before enrollment) on each of the AEDs added/substituted

  4. Percentage of patients free from seizures [ Time Frame: month 6, 12 ]
    Percentage of patients free from seizures during the last 6 and 12 months of follow-up

  5. Percentage of patients with 50% seizure reduction [ Time Frame: month 6 ]
    Percentage of patients with 50% seizure reduction (vs 3-month period before enrollment) during the last 6 months of follow-up

  6. QOLIE-31 scores [ Time Frame: month 6, 12, 18 ]
    Changes in QOLIE-31 scores over time

  7. Beck Depression Inventory (BDI) scores [ Time Frame: month 6, 12, 18 ]
    Changes in Beck Depression Inventory (BDI) scores over time. Higher values represent a worse outcome.

  8. AEP scores [ Time Frame: month 6, 12, 18 ]
    Changes in Adverse Effect Profile (AEP) scores over time

  9. Clinical Global Impression (CGI) scores [ Time Frame: month 6, 12, 18 ]
    Changes in CGI scores over time. CGI is a 5 digit global impression scale for clinical change, compiled separately by the physician and by the patient/caregiver.

  10. Number of AEDs [ Time Frame: month 6, 12, 18 ]
    Number of AEDs changed/substituted over the follow-up period

  11. Total drug load [ Time Frame: month 6, 12, 18 ]
    Changes in total drug load during follow-up. Drug loads, estimated as the sum of the prescribed daily dose (PDD)/defined daily dose (DDD) ratio for each AED included in the treatment regimen, where PDD is the prescribed daily dose and DDD is the defined daily dose, which corresponds to the assumed average maintenance daily dose of a drug used for its main indication.

  12. Adverse effects [ Time Frame: month 6, 12, 18 ]
    Adverse effects, recorded over time, through general and neurological examination and non-structured interview.

  13. Cost data [ Time Frame: month 6, 12, 18 ]
    Cost data are based on patient's records of laboratory tests, doctor's visits, specialist consultations treatments, hospital admissions and day-hospital days during follow up.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Core study:

Inclusion Criteria:

  • an established diagnosis of epilepsy;
  • drug refractoriness, defined as persistence of seizures after adequately applied treatment(s) with one or more appropriate AEDs at maximally tolerated doses, excluding treatments whereby idiosyncratic reactions prevented titration to usually effective dosages;
  • at least one seizure during the previous 6 months while at steady state on the currently used AED regimen;
  • written informed consent.

Exclusion Criteria:

- not seizures during the previous 6 months

Inclusion Criteria for a subgroup of patients, who took part in a randomized assessment:

  • age >16 years;
  • no progressive disorder;
  • ability to complete the Adverse Profile AEP questionnaire;
  • an AEP score >=45

Exclusion criteria:

  • age <16 years;
  • progressive disorder;
  • inability to complete the Adverse Profile AEP questionnaire;
  • an AEP score <45

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939507


Locations
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Italy
Clinical Pharmacology Unit, University of Pavia
Pavia, Italy, 27100
Sponsors and Collaborators
University of Pavia
University of Catanzaro
University of Bologna
Investigators
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Study Director: Emilio Perucca, Prof Clinical Pharmacology Unit, University of Pavia

Publications:

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Responsible Party: University of Pavia
ClinicalTrials.gov Identifier: NCT03939507     History of Changes
Other Study ID Numbers: FARM52K2WM_003
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pavia:
epilepsy,
outcome
antiepileptic drugs
toxicity
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases