Phase 3
N=605
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
Epilepsy, Partial Seizures · Epilepsy, Primary Generalized Tonic-Clonic Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01463306 ↗Enrolled (actual)
605
Serious AEs
12.7%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs — 252; 140; 10; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs |
252; 140; 10; 53; 23; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months |
8; 6; 0; 10; 4; 2 | — |
| PRIMARY Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities |
9; 1; 0; 8; 5; 0 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Baseline |
95; 44; 4; 34; 17; 1 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 12 |
68; 38; 2; 35; 17; 1 | — |
| PRIMARY Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months |
290; 147; 8; 2; 4; 0 | — |
| PRIMARY Absolute Values for Body Height at Baseline |
74.7; 74.8; 92.2; 91.0; 119.3; 118.5 | — |
| PRIMARY Absolute Values for Body Height at Month 12 |
84.4; 85.3; 99.3; 98.1; 128.2; 126.6 | — |
| PRIMARY Number of Participants With Incidence of Laboratory Abnormalities |
297; 164; 8 | — |
| PRIMARY Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY 28-Days Seizure Rate at Week 1 |
102.89; 190.45; 17.83; 2.07; 2.39 | — |
| PRIMARY 28-Days Seizure Rate at Month 1 |
96.39; 178.53; 33.42; 1.43; 1.66 | — |
| PRIMARY 28-Days Seizure Rate at Month 2 |
79.33; 89.09; 22.16; 1.27; 1.36 | — |
| PRIMARY 28-Days Seizure Rate at Month 4 |
67.32; 58.33; 15.45; 1.09; 0.72 | — |
| PRIMARY 28-Days Seizure Rate at Month 6 |
50.18; 51.10; 4.25; 1.02; 0.79 | — |
| PRIMARY 28-Days Seizure Rate at Month 9 |
38.17; 43.13; 3.00; 0.96; 0.62 | — |
| PRIMARY 28-Days Seizure Rate at Month 12/Early Termination |
56.04; 117.88; 11.08; 1.02; 1.33 | — |
| SECONDARY Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) |
3; 2; 1; 3; 2; 0 | — |
| SECONDARY Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) |
1; 1; 0; 2; 0; 0 | — |
| SECONDARY Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task |
21; 8; 2; 13; 6; 1 | — |
| SECONDARY Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task |
17; 9; 2; 16; 6; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01463306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.