Phase 4
Completed N=139
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
Source: ClinicalTrials.gov NCT01689649 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment — 7.0; 2.4; 3.0 percentage of participants
Summary
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED) treatment in monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment |
7.0; 2.4; 3.0 | — |
| PRIMARY Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment |
20.3; 16.9; 16.0 | — |
| PRIMARY Percentage of Seizure Free Participants During the Last 4 Months of Treatment |
58.6; 67.0; 70.0 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks |
3.0; 3.3; 2.0; 17.5; 26.7; 10.0 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks |
3.0; 5.7; 74.3; 5.7; 11.0; 71.0 | — |
| SECONDARY General Clinical Assessment Before and After Treatment |
0.0; 17.9; 1.4; 52.8; 37.7; 25.2 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment |
2.3; 11.4; 70.5; 2.7; 19.2; 69.9 | — |
Eligibility Criteria
Inclusion Criteria
- Has been diagnosed with epilepsy within the past 5 years with Primary Generalized Tonic-Clonic (PGTC) seizures as well as partial onset seizures with or without secondary generalization
- Therapy naive, or being treated with their first anti-epileptic drug (AED) in monotherapy that fails in efficacy, tolerability, or both, and not in need of a combination AED therapy
- Informed Assent in children at least 7 years and older
Exclusion Criteria
- Have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder, toxic exposure, active infection or neoplasia)
- Has any clinically relevant progressive or serious illness (eg, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbance)
- Pregnant or breast-feeding
- Has a history or suspicion of alcohol or drug abuse
- Must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase inhibitors
Data sourced from ClinicalTrials.gov (NCT01689649). 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.