Phase 2
N=7
Thalidomide Low Threshold in Epilepsy
Refractory Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01061866 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
Feb 2010
Primary outcome: Primary: Change From Baseline in the Mean Number of Daily Seizures at 1 Year. — 9 Number of Seizures — p=<0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3-phthalimidoglutarimide (Thalidomide) (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- Male
- Sponsor
- National Institute of Neurology and Neurosurgery, Mexico
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean Number of Daily Seizures at 1 Year. |
9 | <0.02 sig |
Summary
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
Eligibility Criteria
Inclusion Criteria
- Refractory Epilepsy, males
Exclusion Criteria
- Females, peripheric neuropathy
Data sourced from ClinicalTrials.gov (NCT01061866). 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.