Infantile SpasmsNCT01073579
Sabril Patient Registry
An observational study of Infantile Spasms and Refractory Complex Partial Seizures in Adults, run by Lundbeck LLC.
Trial summary
The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infantile Spasms, Refractory Complex Partial Seizures in Adults
- What is being tested?
- Sabril®
- How many people
- 9,423 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. There are no other eligibility criteria for this study.
Who may be able to join
- All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Who cannot join
None listed.
About this study
The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.
Read the detailed description
This prospective registry is part of the overall Risk Evaluation and Mitigation Strategy (REMS) required for Sabril by the United States Food and Drug Administration (FDA). All physicians who prescribe Sabril and all patients who take Sabril will be enrolled in a H. Lundbeck A/S-sponsored program called "SHARE" (Support, Help and Resources for Epilepsy), and the data that are collected and entered into the SHARE database will form the basis of this patient registry.
Prior to any prescription being filled by one of the specialty pharmacies, the prescribing physician and the patient must be enrolled in SHARE. A call center (SHARE Call Center) will act as the hub for a network of select specialty pharmacies. Participation in both SHARE and the patient registry is mandatory.
Information regarding prescriber specialty and location, patient demographic and disease characteristics will be collected through SHARE and entered into the database. Patients will be assigned a unique patient identifier upon entry into the registry, and all data related to that patient will be associated with this identifier.
Early in therapy (within 2-4 weeks for Infantile Spasms patients and 3 months for adult refractory Complex Partial Seizures patients), a mandatory benefit/risk assessment will occur. If the benefit of Sabril therapy exceeds the risk of vision loss, the prescribing physician will complete and submit the appropriate SHARE form and the patient will continue into the maintenance therapy phase of treatment. The outcome of this benefit/risk assessment will be entered into the database.
Regular assessments of vision are required during Sabril therapy to contribute information related to the ongoing benefit/risk assessments. The required assessments will occur at baseline, every 3 months during therapy, and about 3-6 months after stopping Sabril. The visual assessment results will be recorded and submitted using the appropriate SHARE forms, and the data will be entered into the database. A copy of the visual field will be included.
Patients will participate in the registry for as long as they receive Sabril therapy. Patients who discontinue treatment with Sabril, but are treated with it again at a later time will be treated as a single patient in the registry.
- Being tested
- Sabril®
- Keywords
- Cryptogenic Infantile Spasms, Cryptogenic West Syndrome, Hypsarrhythmia, Infantile Spasms, Symptomatic Infantile Spasms, Symptomatic West Syndrome, West Syndrome, Refractory Complex Partial Seizures, Complex Partial Epilepsy, Complex Partial Seizure Disorder, Cryptogenic Partial Complex Epilepsy, Disorder, Complex Partial Seizures, Epilepsy, Cryptogenic, Partial Complex, Epilepsy, Psychic Equivalent, Epilepsy, Psychomotor, Epilepsy, Symptomatic, Partial Complex, Partial Complex Epilepsy, Cryptogenic, Partial Complex Epilepsy, Symptomatic, Seizure Disorder, Complex Partial, Symptomatic Partial Complex Epilepsy
- Medical subject headings
- Spasms, Infantile, Seizures, Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabril®Drug
Also called Vigabatrin
Infantile Spasms (IS): Initiate therapy at 50 mg/kg/day twice daily increasing total daily dose per instructions to a maximum of 150 mg/kg/day.
Refractory Complex Partial Seizures (rCPS) in Adults: Initiate therapy at 500 mg twice daily, increasing total daily dose per instructions. The recommended dose is 1.5 grams twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Sabril® | All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. Receives: Drug: Sabril® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.
Measured: A yearly report
Secondary outcomes (2)
Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.
Measured: A yearly report
Characterize the physician specialties for prescribers of Sabril.
Measured: A yearly report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile SpasmsStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 9,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073579
- Sponsor's protocol ID
- 13101A
- Other IDs
- OV1040
- Status last verified
- Jul 2016
- First submitted
- 22 Feb 2010
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sabril Patient Registry
- ClinicalTrials.gov ID
- NCT01073579
- Acronym / sponsor ID
- 13101A
- Keywords
- Cryptogenic Infantile Spasms, Cryptogenic West Syndrome, Hypsarrhythmia, Infantile Spasms, Symptomatic Infantile Spasms, Symptomatic West Syndrome, West Syndrome, Refractory Complex Partial Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,423 participants (actual)
- Lead sponsor
- Lundbeck LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jul 2016 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
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 create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.
Detailed description
This prospective registry is part of the overall Risk Evaluation and Mitigation Strategy (REMS) required for Sabril by the United States Food and Drug Administration (FDA). All physicians who prescribe Sabril and all patients who take Sabril will be enrolled in a H. Lundbeck A/S-sponsored program called "SHARE" (Support, Help and Resources for Epilepsy), and the data that are collected and entered into the SHARE database will form the basis of this patient registry.
Prior to any prescription being filled by one of the specialty pharmacies, the prescribing physician and the patient must be enrolled in SHARE. A call center (SHARE Call Center) will act as the hub for a network of select specialty pharmacies. Participation in both SHARE and the patient registry is mandatory.
Information regarding prescriber specialty and location, patient demographic and disease characteristics will be collected through SHARE and entered into the database. Patients will be assigned a unique patient identifier upon entry into the registry, and all data related to that patient will be associated with this identifier.
Early in therapy (within 2-4 weeks for Infantile Spasms patients and 3 months for adult refractory Complex Partial Seizures patients), a mandatory benefit/risk assessment will occur. If the benefit of Sabril therapy exceeds the risk of vision loss, the prescribing physician will complete and submit the appropriate SHARE form and the patient will continue into the maintenance therapy phase of treatment. The outcome of this benefit/risk assessment will be entered into the database.
Regular assessments of vision are required during Sabril therapy to contribute information related to the ongoing benefit/risk assessments. The required assessments will occur at baseline, every 3 months during therapy, and about 3-6 months after stopping Sabril. The visual assessment results will be recorded and submitted using the appropriate SHARE forms, and the data will be entered into the database. A copy of the visual field will be included.
Patients will participate in the registry for as long as they receive Sabril therapy. Patients who discontinue treatment with Sabril, but are treated with it again at a later time will be treated as a single patient in the registry.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sabril® | – | Drug: Sabril®All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. There are no other eligibility criteria for this study.
Key inclusion criteria (1 listed)
- All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sabril®Also: VigabatrinInfantile Spasms (IS): Initiate therapy at 50 mg/kg/day twice daily increasing total daily dose per instructions to a maximum of 150 mg/kg/day. Refractory Complex Partial Seizures (rCPS) in Adults: Initiate therapy at 500 mg twice daily, increasing total daily dose per instructions. The recommended dose is 1.5 grams twice daily. | Drug | Sabril® |
Primary outcome
Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.
Time frame: A yearly report
2 secondary outcomes
Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.
Time frame: A yearly report
Characterize the physician specialties for prescribers of Sabril.
Time frame: A yearly report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Spasms and Refractory Complex Partial Seizures in Adults, run by Lundbeck LLC.
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 0 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 29 Jul 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment. (time frame: A yearly report). 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 29 Jul 2016.