Thalidomide Low Threshold in Epilepsy

This study has been completed.
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by:
National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier:
NCT01061866
First received: February 17, 2009
Last updated: February 5, 2010
Last verified: December 2009
  Purpose

The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.


Condition Intervention Phase
Refractory Epilepsy
Drug: 3-phthalimidoglutarimide (Thalidomide)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Refractory Epilepsy With Thalidomide: an Open Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Neurology and Neurosurgery, Mexico:

Primary Outcome Measures:
  • Change From Baseline in the Mean Number of Daily Seizures at 1 Year. [ Time Frame: Baseline 3 months and 1 year of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: June 2006
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thalidomide
Open-labeled preliminary trial
Drug: 3-phthalimidoglutarimide (Thalidomide)
Thalidomide at 200 mg dosage bid was administered during a twelve month period.
Other Names:
  • Talizer
  • 3-phthalimidoglutarimide

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

Ages Eligible for Study:   17 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory Epilepsy, males

Exclusion Criteria:

  • Females, peripheric neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061866

Sponsors and Collaborators
National Institute of Neurology and Neurosurgery, Mexico
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Julio Sotelo, MD National Institute of Neurology and Neurosurgery of Mexico
  More Information

No publications provided

Responsible Party: Julio Sotelo, MD, National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier: NCT01061866     History of Changes
Other Study ID Numbers: INNN 36/06
Study First Received: February 17, 2009
Results First Received: February 17, 2009
Last Updated: February 5, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Neurology and Neurosurgery, Mexico:
Thalidomide
Antiepileptic drugs
Refractory epilepsy
Sedative drugs

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014