Thalidomide Low Threshold in Epilepsy

NCT ID: NCT01061866

Last Updated: 2010-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-01-31

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.

Conditions

Refractory Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thalidomide

Open-labeled preliminary trial

Group Type: EXPERIMENTAL

3-phthalimidoglutarimide (Thalidomide)

Intervention Type: DRUG

Thalidomide at 200 mg dosage bid was administered during a twelve month period.

Interventions

3-phthalimidoglutarimide (Thalidomide)

Thalidomide at 200 mg dosage bid was administered during a twelve month period.

Intervention Type: DRUG

Other Intervention Names

Talizer; 3-phthalimidoglutarimide

Eligibility Criteria

Inclusion Criteria

• Refractory Epilepsy, males

Exclusion Criteria

• Females, peripheric neuropathy

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

National Institute of Neurology and Neurosurgery, Mexico

OTHER

Sponsor Role: lead

Responsible Party

National Institute of Neurology and Neurosurgery, Mexico

Principal Investigators

Julio Sotelo, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurology and Neurosurgery of Mexico

Other Identifiers

INNN 36/06

Identifier Type: -

Identifier Source: org_study_id