EpilepsySOPHIENCT03939507
Outcome Study in Refractory Epilepsy (SOPHIE)
A study testing AEP score available to the treating physician in people with Epilepsy, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- AEP score available to the treating physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2006to 16 Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- age <16 years;
- progressive disorder;
- inability to complete the Adverse Profile AEP questionnaire;
- an AEP score <45
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
With a prevalence of about 0.8% in the general population, chronic active epilepsy is the most common serious neurological disorder and affects 3.7 million people in the EU alone. While the majority of patients with epilepsy can be fully controlled by available medications, about 40% fail to achieve seizure control. Refractory epilepsy is associated with poor quality of life (QoL), due to the consequences of seizures, the burden of adverse effects of antiepileptic drugs (AEDs), and associated comorbidities, especially depressed mood. In addition to human suffering, refractory epilepsy entails major costs: observational studies in Italy estimated an annual medical costs at 2,190 in adults, or 3,268 euros in children.
The study had a prospective design and mainly observational design (core study). A subgroup of patients, participated in a randomized assessment (controlled study) of the impact of utilizing a standardized tool for the assessment of adverse effects.
For the core study, the study population was represented by 1,000 consecutive consenting patients with refractory epilepsy seen as in- or outpatients at 10 major secondary/tertiary referral centres in Italy. "Refractory epilepsy" was defined as "the persistence of seizures after adequate attempts with the maximally tolerated dosage of one or more appropriate primary AEDs, excluding situations where a meaningful dose escalation was prevented by allergic or idiosyncratic adverse reactions" and at least one seizure during the previous 3 months while at steady state on the current treatment schedule. The degree of refractoriness was classified into categories.
A subcohort of patients included in the study took part in a randomized assessment of the usefulness of providing the treating physician with a standardized assessment of the adverse effect profile. The subcohort was represented by all patients enrolled in the core study who met at the first assessment visit the following additional eligibility criteria: (i) age >16 years; (ii) no progressive disorder; (iii) ability to complete the Adverse Profile AEP questionnaire, and (iv) an AEP score >=45.
For the core study, the approach was observational and the study did not interfere with clinical management. All patients were treated as considered best by the attending physician. Results of questionnaires were not made available to the treating physician until the end of the study, except for the AEP questionnaire data that were fed back to the physician only for a subgroup of patients included in the randomized assessment.
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. Evaluations were identical to those carried out in the core study.
Except for making available the AEP scores to the treating physician, the procedures used for the collection and the handling of the information were identical in the core study and the randomized assessment. Patients were seen in the clinic at the following times: 0 (enrolment), 6, 12 and 18 months. At the first visit, detailed information were collected about demographics, medical history and current medical status. At this visit and at each of the other visits, the following information were collected:
- QOLIE-31 scores (only patients aged >16years), using the validated epilepsy-specific questionnaire, which is the most widely used for QoL tool in epilepsy in different countries;
- BDI scores (only patients aged >16years), using the validated inventory developed by Beck (1961), shown to have reliability and sensitivity in different settings, including refractory epilepsy ;
- AEP scores (only patients aged >16years), using the epilepsy-specific validated scale developed by prof. Baker ;
- A 5 digit Global Impression Scale for clinical change, compiled separately by the physician and by the patient/caregiver;
- Seizure frequency, by using seizure diaries compiled by patients and/or caregivers.
- Adverse effects, through general and neurological examination and non-structured interview;
- Drug treatment details (including, when available, serum AED levels), from the prescriber and patient's interview, and drug load scores as described by prof. Deckers;
- Items to be used for cost calculations, based on patient's records of laboratory tests, doctor's visits, specialist consultations, treatments, hospital admissions, and day-hospital days during follow up.
The study duration was 36 months.
- Conditions
- Epilepsy
- Being tested
- AEP score available to the treating physician
- Keywords
- epilepsy,, outcome, antiepileptic drugs, toxicity
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEP score available to the treating physicianOther
the treating physician knew the AEP score results
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | AEP score results were made available to the treating physician at each assessment visit. Receives: Other: AEP score available to the treating physician |
| Control group | No intervention | AEP scores were only made available at the end of follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life In Epilepsy (QOLIE)-31 global score
The change in QOLIE-31 global score (final visit vs initial visit). QOLIE-31 is a widely used epilepsy-specific questionnaire
Measured: Month 18
Adverse Events Profiles (AEP) score
The change in AEP score (final visit vs initial visit). The epilepsy-specific validated scale was used. Higher values represent a worse outcome.
Measured: Month 18
Secondary outcomes (13)
Retention patients and AntiEpileptic Drugs (AEDs) added/substituted
Retention of patients on each of the AEDs added/substituted
Measured: month 6, 12, 18
Percentage of patients seizure free on each of the AEDs added/substituted
Percentage of patients free achieving 6- and 12-month seizure remission on each of the AEDs added/substituted
Measured: month 6, 12
Percentage of patients with 50% seizure reduction on each of the AEDs added/substituted
Percentage of patients with 50% seizure reduction over 6 months (vs 3-month period before enrollment) on each of the AEDs added/substituted
Measured: month 6
Percentage of patients free from seizures
Percentage of patients free from seizures during the last 6 and 12 months of follow-up
Measured: month 6, 12
Percentage of patients with 50% seizure reduction
Percentage of patients with 50% seizure reduction (vs 3-month period before enrollment) during the last 6 months of follow-up
Measured: month 6
QOLIE-31 scores
Changes in QOLIE-31 scores over time
Measured: month 6, 12, 18
Beck Depression Inventory (BDI) scores
Changes in Beck Depression Inventory (BDI) scores over time. Higher values represent a worse outcome.
Measured: month 6, 12, 18
AEP scores
Changes in Adverse Effect Profile (AEP) scores over time
Measured: month 6, 12, 18
Clinical Global Impression (CGI) scores
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.
Measured: month 6, 12, 18
Number of AEDs
Number of AEDs changed/substituted over the follow-up period
Measured: month 6, 12, 18
Total drug load
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.
Measured: month 6, 12, 18
Adverse effects
Adverse effects, recorded over time, through general and neurological examination and non-structured interview.
Measured: month 6, 12, 18
Cost data
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.
Measured: month 6, 12, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start6 Nov 2006
- Primary completion16 Jul 2009
- Study completion16 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catanzaro, University of Bologna
- Responsible party
- Sponsor
- Investigators
- Emilio Perucca, Prof, Study director, Clinical Pharmacology Unit, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939507
- Sponsor's protocol ID
- FARM52K2WM_003
- Acronym
- SOPHIE
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beghi E, Gatti G, Tonini C, Ben-Menachem E, Chadwick DW, Nikanorova M, Gromov SA, Smith PE, Specchio LM, Perucca E; BASE Study Group. Adjunctive therapy versus alternative monotherapy in patients with partial epilepsy failing on a single drug: a multicentre, randomised, pragmatic controlled trial. Epilepsy Res. 2003 Nov;57(1):1-13. doi: 10.1016/j.eplepsyres.2003.09.007.
PubMed 14706729Beghi E, Garattini L, Ricci E, Cornago D, Parazzini F; EPICOS Group. Direct cost of medical management of epilepsy among adults in Italy: a prospective cost-of-illness study (EPICOS). Epilepsia. 2004 Feb;45(2):171-8. doi: 10.1111/j.0013-9580.2004.14103.x.
PubMed 14738425Devinsky O, Vickrey BG, Cramer J, Perrine K, Hermann B, Meador K, Hays RD. Development of the quality of life in epilepsy inventory. Epilepsia. 1995 Nov;36(11):1089-104. doi: 10.1111/j.1528-1157.1995.tb00467.x.
PubMed 7588453Jannuzzi G, Cian P, Fattore C, Gatti G, Bartoli A, Monaco F, Perucca E. A multicenter randomized controlled trial on the clinical impact of therapeutic drug monitoring in patients with newly diagnosed epilepsy. The Italian TDM Study Group in Epilepsy. Epilepsia. 2000 Feb;41(2):222-30. doi: 10.1111/j.1528-1157.2000.tb00144.x.
PubMed 10691121Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
PubMed 10660394Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.
PubMed 11971128Perucca E. Marketed new antiepileptic drugs: are they better than old-generation agents? Ther Drug Monit. 2002 Feb;24(1):74-80. doi: 10.1097/00007691-200202000-00013.
PubMed 11805726Perucca E. An introduction to antiepileptic drugs. Epilepsia. 2005;46 Suppl 4:31-7. doi: 10.1111/j.1528-1167.2005.463007.x.
PubMed 15968807Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7. doi: 10.1212/wnl.62.1.23.
PubMed 14718691Johnson EK, Jones JE, Seidenberg M, Hermann BP. The relative impact of anxiety, depression, and clinical seizure features on health-related quality of life in epilepsy. Epilepsia. 2004 May;45(5):544-50. doi: 10.1111/j.0013-9580.2004.47003.x.
PubMed 15101836Franco V, Canevini MP, De Sarro G, Fattore C, Fedele G, Galimberti CA, Gatti G, La Neve A, Rosati E, Specchio LM, Striano S, Tinuper P, Perucca E; SOPHIE Study Group. Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial. Neurology. 2020 Jul 21;95(3):e239-e246. doi: 10.1212/WNL.0000000000009880. Epub 2020 Jun 29.
PubMed 32601123
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03939507
- Acronym / sponsor ID
- SOPHIE / FARM52K2WM_003
- Conditions
- Epilepsy
- Keywords
- epilepsy,, outcome, antiepileptic drugs, toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- University of Catanzaro, University of Bologna
- Study start
- 6 Nov 2006 (actual)
- Primary completion
- 16 Jul 2009 (actual)
- Study completion
- 16 Jul 2009 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With a prevalence of about 0.8% in the general population, chronic active epilepsy is the most common serious neurological disorder and affects 3.7 million people in the EU alone. While the majority of patients with epilepsy can be fully controlled by available medications, about 40% fail to achieve seizure control. Refractory epilepsy is associated with poor quality of life (QoL), due to the consequences of seizures, the burden of adverse effects of antiepileptic drugs (AEDs), and associated comorbidities, especially depressed mood. In addition to human suffering, refractory epilepsy entails major costs: observational studies in Italy estimated an annual medical costs at 2,190 in adults, or 3,268 euros in children.
The study had a prospective design and mainly observational design (core study). A subgroup of patients, participated in a randomized assessment (controlled study) of the impact of utilizing a standardized tool for the assessment of adverse effects.
For the core study, the study population was represented by 1,000 consecutive consenting patients with refractory epilepsy seen as in- or outpatients at 10 major secondary/tertiary referral centres in Italy. "Refractory epilepsy" was defined as "the persistence of seizures after adequate attempts with the maximally tolerated dosage of one or more appropriate primary AEDs, excluding situations where a meaningful dose escalation was prevented by allergic or idiosyncratic adverse reactions" and at least one seizure during the previous 3 months while at steady state on the current treatment schedule. The degree of refractoriness was classified into categories.
A subcohort of patients included in the study took part in a randomized assessment of the usefulness of providing the treating physician with a standardized assessment of the adverse effect profile. The subcohort was represented by all patients enrolled in the core study who met at the first assessment visit the following additional eligibility criteria: (i) age >16 years; (ii) no progressive disorder; (iii) ability to complete the Adverse Profile AEP questionnaire, and (iv) an AEP score >=45.
For the core study, the approach was observational and the study did not interfere with clinical management. All patients were treated as considered best by the attending physician. Results of questionnaires were not made available to the treating physician until the end of the study, except for the AEP questionnaire data that were fed back to the physician only for a subgroup of patients included in the randomized assessment.
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. Evaluations were identical to those carried out in the core study.
Except for making available the AEP scores to the treating physician, the procedures used for the collection and the handling of the information were identical in the core study and the randomized assessment. Patients were seen in the clinic at the following times: 0 (enrolment), 6, 12 and 18 months. At the first visit, detailed information were collected about demographics, medical history and current medical status. At this visit and at each of the other visits, the following information were collected:
- QOLIE-31 scores (only patients aged >16years), using the validated epilepsy-specific questionnaire, which is the most widely used for QoL tool in epilepsy in different countries;
- BDI scores (only patients aged >16years), using the validated inventory developed by Beck (1961), shown to have reliability and sensitivity in different settings, including refractory epilepsy ;
- AEP scores (only patients aged >16years), using the epilepsy-specific validated scale developed by prof. Baker ;
- A 5 digit Global Impression Scale for clinical change, compiled separately by the physician and by the patient/caregiver;
- Seizure frequency, by using seizure diaries compiled by patients and/or caregivers.
- Adverse effects, through general and neurological examination and non-structured interview;
- Drug treatment details (including, when available, serum AED levels), from the prescriber and patient's interview, and drug load scores as described by prof. Deckers;
- Items to be used for cost calculations, based on patient's records of laboratory tests, doctor's visits, specialist consultations, treatments, hospital admissions, and day-hospital days during follow up.
The study duration was 36 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: AEP score available to the treating physicianAEP score results were made available to the treating physician at each assessment visit. |
| Control group | No intervention | –AEP scores were only made available at the end of follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- not seizures during the previous 6 months
- age >16 years;
- no progressive disorder;
- ability to complete the Adverse Profile AEP questionnaire;
- an AEP score >=45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEP score available to the treating physicianthe treating physician knew the AEP score results | Other | Intervention group |
Primary outcome
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
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.
13 secondary outcomes
Retention patients and AntiEpileptic Drugs (AEDs) added/substituted
Time frame: month 6, 12, 18
Percentage of patients seizure free on each of the AEDs added/substituted
Time frame: month 6, 12
Percentage of patients with 50% seizure reduction on each of the AEDs added/substituted
Time frame: month 6
Percentage of patients free from seizures
Time frame: month 6, 12
Percentage of patients with 50% seizure reduction
Time frame: month 6
QOLIE-31 scores
Time frame: month 6, 12, 18
Beck Depression Inventory (BDI) scores
Time frame: month 6, 12, 18
AEP scores
Time frame: month 6, 12, 18
Clinical Global Impression (CGI) scores
Time frame: month 6, 12, 18
Number of AEDs
Time frame: month 6, 12, 18
Total drug load
Time frame: month 6, 12, 18
Adverse effects
Time frame: month 6, 12, 18
Cost data
Time frame: month 6, 12, 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 14706729Beghi E, Gatti G, Tonini C, Ben-Menachem E, Chadwick DW, Nikanorova M, Gromov SA, Smith PE, Specchio LM, Perucca E; BASE Study Group. Adjunctive therapy versus alternative monotherapy in patients with partial epilepsy failing on a single drug: a multicentre, randomised, pragmatic controlled trial. Epilepsy Res. 2003 Nov;57(1):1-13. doi: 10.1016/j.eplepsyres.2003.09.007.
- Background: PubMed 14738425Beghi E, Garattini L, Ricci E, Cornago D, Parazzini F; EPICOS Group. Direct cost of medical management of epilepsy among adults in Italy: a prospective cost-of-illness study (EPICOS). Epilepsia. 2004 Feb;45(2):171-8. doi: 10.1111/j.0013-9580.2004.14103.x.
- Background: PubMed 7588453Devinsky O, Vickrey BG, Cramer J, Perrine K, Hermann B, Meador K, Hays RD. Development of the quality of life in epilepsy inventory. Epilepsia. 1995 Nov;36(11):1089-104. doi: 10.1111/j.1528-1157.1995.tb00467.x.
- Background: PubMed 10691121Jannuzzi G, Cian P, Fattore C, Gatti G, Bartoli A, Monaco F, Perucca E. A multicenter randomized controlled trial on the clinical impact of therapeutic drug monitoring in patients with newly diagnosed epilepsy. The Italian TDM Study Group in Epilepsy. Epilepsia. 2000 Feb;41(2):222-30. doi: 10.1111/j.1528-1157.2000.tb00144.x.
- Background: PubMed 10660394Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
- Background: PubMed 11971128Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.
- Background: PubMed 11805726Perucca E. Marketed new antiepileptic drugs: are they better than old-generation agents? Ther Drug Monit. 2002 Feb;24(1):74-80. doi: 10.1097/00007691-200202000-00013.
- Background: PubMed 15968807Perucca E. An introduction to antiepileptic drugs. Epilepsia. 2005;46 Suppl 4:31-7. doi: 10.1111/j.1528-1167.2005.463007.x.
- Background: PubMed 14718691Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7. doi: 10.1212/wnl.62.1.23.
- Background: PubMed 15101836Johnson EK, Jones JE, Seidenberg M, Hermann BP. The relative impact of anxiety, depression, and clinical seizure features on health-related quality of life in epilepsy. Epilepsia. 2004 May;45(5):544-50. doi: 10.1111/j.0013-9580.2004.47003.x.
- Derived from this study: PubMed 32601123Franco V, Canevini MP, De Sarro G, Fattore C, Fedele G, Galimberti CA, Gatti G, La Neve A, Rosati E, Specchio LM, Striano S, Tinuper P, Perucca E; SOPHIE Study Group. Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial. Neurology. 2020 Jul 21;95(3):e239-e246. doi: 10.1212/WNL.0000000000009880. Epub 2020 Jun 29.
- Individual participant dataSharing planned: No
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Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Perucca, Prof study director
Clinical Pharmacology Unit, University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AEP score available to the treating physician in people with Epilepsy, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life In Epilepsy (QOLIE)-31 global score (time frame: Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939507, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.