NCT01061866

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
Same day until next milestone

Results Posted

Study results publicly available

February 3, 2010

Completed
Last Updated

February 18, 2010

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

February 17, 2009

Results QC Date

February 17, 2009

Last Update Submit

February 5, 2010

Conditions

Refractory Epilepsy

Keywords

ThalidomideAntiepileptic drugsRefractory epilepsySedative drugs

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Mean Number of Daily Seizures at 1 Year.

    Baseline 3 months and 1 year of treatment

Study Arms (1)

Thalidomide

EXPERIMENTAL

Open-labeled preliminary trial

Drug: 3-phthalimidoglutarimide (Thalidomide)

Interventions

3-phthalimidoglutarimide (Thalidomide)DRUG

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

Also known as: Talizer, 3-phthalimidoglutarimide
Thalidomide

Eligibility Criteria

Age17 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Refractory Epilepsy, males

You may not qualify if:

  • Females, peripheric neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Julio Sotelo
Organization
National Institute of Neurology and Neurosurgery of Mexico
jsotelo@unam.mx
5255-5652-8285

Study Officials

  • Julio Sotelo, MD

    National Institute of Neurology and Neurosurgery of Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 3, 2010

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

January 1, 2008

Last Updated

February 18, 2010

Results First Posted

February 3, 2010

Record last verified: 2009-12