Thalidomide Low Threshold in Epilepsy
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): 3-phthalimidoglutarimide (Thalidomide)
Intervention type(s): Drug
Intervention description(s): Thalidomide at 200 mg dosage bid was administered during a twelve month period.
Other intervention name(s): Talizer; 3-phthalimidoglutarimide
Intervention MeSH terms: Thalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thalidomide; Antiepileptic drugs; Refractory epilepsy; Sedative drugs