Refractory Epilepsy
Conditions
Keywords
Thalidomide, Antiepileptic drugs, Refractory epilepsy, Sedative drugs
Brief summary
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
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.
Interventions
DRUG3-phthalimidoglutarimide (Thalidomide)
Thalidomide at 200 mg dosage bid was administered during a twelve month period.
Sponsors
National Council of Science and Technology, Mexico
National Institute of Neurology and Neurosurgery, Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
17 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Refractory Epilepsy, males
Exclusion criteria
* Females, peripheric neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Mean Number of Daily Seizures at 1 Year. | Baseline 3 months and 1 year of treatment |
Participant flow
Recruitment details
Patients with refractory epilepsy, 25 years old mean, with antiepileptic treatment and several seizures by month and male gender and they were recruited by Epilepsy Clinic
Pre-assignment details
Males without seizures three months prior to thalidomide administration and patients without electroencephalographic study and without antiepileptic treatment.
Participants by arm
| Arm | Count |
|---|---|
| Thalidomide Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Thalidomide |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age Continuous | 25 years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 2 / 7 |
Outcome results
Primary
Change From Baseline in the Mean Number of Daily Seizures at 1 Year.
Time frame: Baseline 3 months and 1 year of treatment
Population: males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thalidomide | Change From Baseline in the Mean Number of Daily Seizures at 1 Year. | 9 Number of Seizures | Standard Error 2 |
Comparison: Power=0.02p-value: <0.02ANOVA