Phase 4
Completed N=111
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Source: ClinicalTrials.gov NCT00855738 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Percent of Participants Classified as Responders — 76.7; 80.0 percent of participants — p=<0.0001
Summary
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Classified as Responders |
76.7; 80.0 | <0.0001 sig |
| SECONDARY Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment |
86.7; 27.8; 86.7; 54.4 | <0.0001 sig |
| SECONDARY Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation |
10.0; 20.0 | 0.0039 sig |
| SECONDARY Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment |
-75.0 | <0.0001 sig |
| SECONDARY Percent of Days Without Crisis During the Study |
— | — |
| SECONDARY Time to First Seizure |
35.9 | — |
| SECONDARY Percent of Participants Who Continued on Study Medication to Month 6 |
97.1 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
— | — |
| SECONDARY Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance |
— | — |
| SECONDARY Time to Discontinuation Due to Other Reasons |
— | — |
| SECONDARY Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS) |
— | — |
| SECONDARY Percent of Participants Reaching Monotherapy |
2.9 | — |
| SECONDARY Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED) |
0.9; 68.5; 30.6 | — |
| SECONDARY Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy |
0.0; 100.0; 0.0 | — |
| SECONDARY Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS) |
-0.5; -0.6 | 0.1797 |
| SECONDARY Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10) |
0.4; 0.7; 0.6; 1.2; -1.1; 9.0 | 0.8284 |
| SECONDARY Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS) |
-0.4; 1.2 | 0.7822 |
| SECONDARY Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS) |
-1.7; 0.0; 1.1; 0.2; 2.8; 0.6 | 0.2452 |
| SECONDARY Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS) |
56.5; 65.7 | 0.0863 |
| SECONDARY Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy |
-0.6; -0.3 | 0.0226 sig |
| SECONDARY Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy |
-8.0 | 0.3141 |
| SECONDARY Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit |
16.2; 6.6; 0.0 | 0.0708 |
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older.
- Diagnosis of focal epilepsy.
- Previous failure of one or more AEDs used in monotherapy.
- Background treatment with an antiepileptic drug.
- The investigator has considered that the patient must start treatment with some of the seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin, oxcarbazepine, pregabalin, tiagabine and/or topiramate.
- History of seizures in the patient in the past 3 months.
- The patient or legal guardian must be able to understand the characteristics of the study and fill in the seizure diaries.
- Written informed consent.
Exclusion Criteria
- Inability to comply with the study requirements.
- Diagnosis of generalized epilepsy or inability to establish if focal or generalized.
- Presence of serious or uncontrolled systemic disease, serious psychiatric disease or progressive neurological disease.
- History of alcoholism, drug addiction, or abuse of medicines in the past two years.
- Psychogenic seizures in the two years prior to inclusion in the study.
Data sourced from ClinicalTrials.gov (NCT00855738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.