Refractory EpilepsyPhase 1/2NCT01061866
Thalidomide Low Threshold in Epilepsy
A Phase 1/2 study testing 3-phthalimidoglutarimide (Thalidomide) in people with Refractory Epilepsy, run by National Institute of Neurology and Neurosurgery, Mexico.
Trial summary
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment. Read more about this study
- Who is it for?
- Ages 17 to 40 years, men only
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- 3-phthalimidoglutarimide (Thalidomide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jan 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Refractory Epilepsy, males
Who cannot join
- Females, peripheric neuropathy
About this study
Official title: Treatment of Refractory Epilepsy With Thalidomide: an Open Trial
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
Read the 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
- Being tested
- 3-phthalimidoglutarimide (Thalidomide)
- Keywords
- Thalidomide, Antiepileptic drugs, Refractory epilepsy, Sedative drugs
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-phthalimidoglutarimide (Thalidomide)Drug
Also called Talizer, 3-phthalimidoglutarimide
Thalidomide at 200 mg dosage bid was administered during a twelve month period.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Experimental | Open-labeled preliminary trial Receives: Drug: 3-phthalimidoglutarimide (Thalidomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Mean Number of Daily Seizures at 1 Year.
Measured: Baseline 3 months and 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurology and Neurosurgery, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Investigators
- Julio Sotelo, MD, Principal investigator, National Institute of Neurology and Neurosurgery of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061866
- Sponsor's protocol ID
- INNN 36/06
- Status last verified
- Dec 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Epilepsy With Thalidomide: an Open Trial
- ClinicalTrials.gov ID
- NCT01061866
- Acronym / sponsor ID
- INNN 36/06
- Conditions
- Refractory Epilepsy
- Keywords
- Thalidomide, Antiepileptic drugs, Refractory epilepsy, Sedative drugs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Neurology and Neurosurgery, MexicoUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 3 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Experimental | Drug: 3-phthalimidoglutarimide (Thalidomide)Open-labeled preliminary trial |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Refractory Epilepsy, males
Key exclusion criteria (1 listed)
- Females, peripheric neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-phthalimidoglutarimide (Thalidomide)Also: Talizer, 3-phthalimidoglutarimideThalidomide at 200 mg dosage bid was administered during a twelve month period. | Drug | Thalidomide |
Primary outcome
Change From Baseline in the Mean Number of Daily Seizures at 1 Year.
Time frame: Baseline 3 months and 1 year of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Sotelo, MD principal investigator
National Institute of Neurology and Neurosurgery of Mexico
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 3-phthalimidoglutarimide (Thalidomide) in people with Refractory Epilepsy, run by National Institute of Neurology and Neurosurgery, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Mean Number of Daily Seizures at 1 Year. (time frame: Baseline 3 months and 1 year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.