Phase 3
Completed N=102
Clinical Evaluation of BW430C in Epilepsy
Source: ClinicalTrials.gov NCT00395694 ↗Enrolled (actual)
102
Serious AEs
6.9%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment — 2; 3; 5 participants
Summary
To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment |
2; 3; 5 | — |
| SECONDARY Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment |
3; 4; 7 | — |
| SECONDARY Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment |
0; 2; 3 | — |
| SECONDARY Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment |
3; 4 | — |
| SECONDARY Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures |
17.9; 20.0; 18.9; 60.0; 0; 33.3 | — |
| SECONDARY Percent Change in Seizure Frequency of the Indicated Types of Seizures |
6.3; -11.1; -9.8; 83.3; 27.4; 36.5 | — |
| SECONDARY Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase |
2; 3; 5 | — |
| SECONDARY Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase |
3; 4; 7 | — |
| SECONDARY Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase |
0; 2; 3 | — |
| SECONDARY Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase |
3; 4 | — |
| SECONDARY Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA |
1; 2; 3 | — |
| SECONDARY Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8 |
15.2; 16.2 | — |
Eligibility Criteria
Inclusion criteria
- Epilepsy with partial seizures
- Tonic clonic seizures
- Generalized seizures of Lennox-Gastaut
- Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
- Concurrent AEDs: Subjects taking concurrent VPA.
Exclusion criteria
- Previous participation in a study of Lamictal
- Known hypersensitivity to any drugs
- Pregnant women
- nursing mothers
- women who may be pregnant
- women contemplating pregnancy during the study period
Data sourced from ClinicalTrials.gov (NCT00395694). 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.