A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
NCT01389596
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
- Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
- Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
- Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
- Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).
- Primary generalized seizures (including in the setting of co-existing partial onset
seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note
that partial onset seizures that become secondarily generalized are not exclusionary);
Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic
seizures.
- Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet
syndrome.
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness. Any febrile seizures within 1 year of screening.
- Status epilepticus within 1 year prior to screening.
- Seizures related to drugs, alcohol, or acute medical illness.
- Any change in AED regimen (type of medication or dose) within 28 days of the Screening
Visit or during the Baseline Phase.
- Progressive structural CNS lesion or a progressive encephalopathy.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years | ||||||
| Official Title ICMJE | A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES | ||||||
| Brief Summary | Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Epilepsy, Partial Seizures | ||||||
| Intervention ICMJE | Drug: Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. | ||||||
| Study Arms ICMJE |
| ||||||
| Publications * | Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 295 | ||||||
| Original Estimated Enrollment ICMJE | 153 | ||||||
| Actual Study Completion Date ICMJE | August 10, 2016 | ||||||
| Actual Primary Completion Date | August 10, 2016 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 4 Years to 16 Years (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Belgium, Bulgaria, Czechia, France, Greece, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Philippines, Poland, Romania, Serbia, Singapore, Turkey, Ukraine, United States | ||||||
| Removed Location Countries | Austria, Czech Republic, Estonia, Finland, India, Lithuania, Netherlands, Sweden | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01389596 | ||||||
| Other Study ID Numbers ICMJE | A0081041 2010-020852-79 ( EudraCT Number ) XALCORY 1014 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | January 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||