Thalidomide Low Threshold in Epilepsy
Information source: National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Refractory Epilepsy
Intervention: 3-phthalimidoglutarimide (Thalidomide) (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Institute of Neurology and Neurosurgery, Mexico Official(s) and/or principal investigator(s): Julio Sotelo, MD, Principal Investigator, Affiliation: National Institute of Neurology and Neurosurgery of Mexico
Summary
The purpose of this study is to determine whether thalidomide is effective in the refractory
epilepsy treatment.
Clinical Details
Official title: Treatment of Refractory Epilepsy With Thalidomide: an Open Trial
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in the Mean Number of Daily Seizures at 1 Year.
Detailed description:
Seven male patients with chronic, refractory epilepsy were included in the present study; in
all cases antiepileptic treatment with multiple antiepileptic drugs had been unsuccessful in
reducing the frequency or the intensity of seizures. Patients selected for this study were
all males due to the high risk of thalidomide for teratogenicity in pregnant women; besides
this drawback, thalidomide presents a fair tolerance profile in humans treated with low
doses. Informed consent was obtained on each case by the patient and his legal guardian. The
protocol was approved by the committees of research and ethics.
Treatment with thalidomide at 200 mg dosage twice daily was administered during a twelve
month period. Electroencephalograms were obtained prior and at six months of thalidomide
therapy; number and intensity of seizures were individually recorded in a diary by a
caregiver (in most cases the patient's mother); signs of neuropathy, a frequent side-effect
of chronic thalidomide therapy, were evaluated along the treatment; drowsiness and sedation,
which are also common side-effects, were also recorded.
Patients were seen once a week during the treatment period at the Epilepsy Clinic of the
National Institute of Neurology and Neurosurgery of Mexico. Once informed consent was
obtained, all patients were given seizure diaries to be filled for three months before
starting the treatment with thalidomide. Comparisons in the frequency of seizures were made
on each patient by contrasting the three months previous to the beginning of thalidomide
therapy with the twelve months of the drug trial. One patient (case 6) withdrew from the
trial after seven months of thalidomide therapy due to sedation. Another patient (case 7)
withdrew from the trial after 3 months of treatment due to exacerbation of seizures as
narrated by his mother.
The same schedule of antiepileptic therapy was taken by each patient during three months
prior to thalidomide administration and continued it without modification along the trial;
therefore, bias due to changes in the associated antiepileptic medications were prevented
and each patient served as his own control; so that the effect of thalidomide on the
frequency and intensity of seizures could be reasonably evaluated. Thalidomide was purchased
by the National Institute of Neurology and Neurosurgery of Mexico at regular price in the
pharmaceutical market. No pharmaceutical company participated in any form in this trial.
Eligibility
Minimum age: 17 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Refractory Epilepsy, males
Exclusion Criteria:
- Females, peripheric neuropathy
Locations and Contacts
Additional Information
Starting date: June 2006
Last updated: February 5, 2010
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