Trial Outcomes & Findings for Thalidomide Low Threshold in Epilepsy (NCT NCT01061866)

NCT ID: NCT01061866

Last Updated: 2010-02-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline 3 months and 1 year of treatment
• Results posted on: 2010-02-18

Participant Flow

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

Males without seizures three months prior to thalidomide administration and patients without electroencephalographic study and without antiepileptic treatment.

Participant milestones

Measure	Thalidomide Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Thalidomide Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Overall Study Adverse Event	2

Baseline Characteristics

Thalidomide Low Threshold in Epilepsy

Baseline characteristics by cohort

Measure	Thalidomide n=7 Participants 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	25 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline 3 months and 1 year of treatment

Population: males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study

Outcome measures

Measure	Thalidomide n=7 Participants Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Change From Baseline in the Mean Number of Daily Seizures at 1 Year.	9 Number of Seizures Standard Error 2

Adverse Events

Thalidomide

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Thalidomide n=7 participants at risk Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Nervous system disorders sedation	14.3% 1/7 • Number of events 1 • 1 year During the trial we observed two serious adverse events, one of them presented exacerbation of seizures, another patient showed sedation, at 3 and 7 months respectively to the beginning of treatment. Other adverse events consisted in sensory neuropathy in 2 out of 7 patients tested with nerve conduction studies.
Nervous system disorders seizures exacerbation	14.3% 1/7 • Number of events 1 • 1 year During the trial we observed two serious adverse events, one of them presented exacerbation of seizures, another patient showed sedation, at 3 and 7 months respectively to the beginning of treatment. Other adverse events consisted in sensory neuropathy in 2 out of 7 patients tested with nerve conduction studies.

Other adverse events

Measure	Thalidomide n=7 participants at risk Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Nervous system disorders sensorial neuropathy	14.3% 1/7 • Number of events 1 • 1 year During the trial we observed two serious adverse events, one of them presented exacerbation of seizures, another patient showed sedation, at 3 and 7 months respectively to the beginning of treatment. Other adverse events consisted in sensory neuropathy in 2 out of 7 patients tested with nerve conduction studies.

Additional Information

Julio Sotelo

National Institute of Neurology and Neurosurgery of Mexico

Phone: 5255-5652-8285

Email: jsotelo@unam.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place