A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pedia… (NCT01463306) | Clinical Trial Compass
CompletedPhase 3
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
United States, Belarus, Belgium605 participantsStarted 2012-02-21
Plain-language summary
Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
Who can participate
Age range
1 Month – 66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.
* Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
* Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
* Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
* Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).
Exclusion Criteria:
* Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
* A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
* Status epilepticus within 1 year prior to visit 1.
* Seizures related to drugs, alcohol, or acute medical illness.
* Progressive structural CNS lesion or a progressive encephalopathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
Timeframe: Baseline (Day 1) up to 13 Months
2
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Timeframe: Baseline up to 12 Months
3
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Timeframe: Baseline up to 12 months
4
Number of Participants With Tanner Staging Evaluation at Baseline
Timeframe: Baseline (Day 1)
5
Number of Participants With Tanner Staging Evaluation at Month 12
Timeframe: Month 12
6
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
Timeframe: Baseline up to 12 Months
7
Trial details
NCT IDNCT01463306
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.