A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin as Adjunctive Therapy in Children 1 Month through <4 Years of Age with Partial Onset Seizures.

Phase 3

Withdrawn

• Conditions: partial onset seizures; 10029305

• Registration Number: NL-OMON40899
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/guardian(s) have been informed of all pertinent aspects of the study. When there are 2 parents, or 2 guardians, consent should be obtained from both of the child*s parents/guardians if present at the meeting where the informed consent document is signed.
2. Subjects and Parent(s)/guardian(s)/caregiver(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male and female subjects, 1 month (44 weeks gestational age) through <4 years of age inclusive on the date of the Screening Visit with a diagnosis of epilepsy with seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE 20103 see Appendix 1) Diagnosis must be established by:
* Subject*s seizure history (eg, description of seizures excluding confounding disorders such as pseudoseizures etc), family history and neurological exam.
* Subjects must have previously had a contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and EEG testing. Results must be consistent with the diagnosis of focal onset epilepsy and must demonstrate that no abnormality is likely to be progressive .
* In the event that a CT or MRI scan is needed, it should be performed as soon as possible after Visit 1 if it cannot be performed the day of this visit and must be completed and reviewed prior to randomization.
4. Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 7 days prior to screening). Benzodiazepine medication used on a regular basis at a stable dosage will be considered 1 of the concurrent antiepileptic treatments, Vagus Nerve Stimulator when present will also be considered 1 of the concurrent antiepileptic treatments.
5. A 12 lead ECG at screening without clinically significant abnormal findings as determined by the investigator. Potentially clinically significant abnormal findings will be reviewed by a pediatric cardiologist at the central ECG laboratory.
6. Subjects must have had at least 3 observed seizures in the month prior to screening.
7. Subjects must have at least 2 partial onset seizures as determined by the investigator or designee during the 48 hour baseline Video EEG phase.

Exclusion Criteria

1. Primary generalized seizures (including in the setting of co existing partial onset seizures) which may 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.
2. Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
3. A current diagnosis of febrile seizures or seizures related to an ongoing acute medical illness.
4. Exacerbation of partial onset seizures due to fever occurring within 60 days of screening.
5. Status epilepticus within 1 year prior to screening.
6. Seizures related to acute medical illness.
7. Any change in AED regimen (type of medication or dose) within 7 days of the Screening Visit or during the Baseline Phase.
8. Progressive structural central nervous sytem (CNS) lesion or a progressive encephalopathy.
9. Progressive errors of metabolism.
10. Known or suspected chronic hematologic, hepatic or renal disease (AST and ALT) above 3 times the upper limit of normal (ULN); or bilirubin, BUN, or creatinine above 2 times the ULN within the previous 6 months prior to screening). Subjects who experienced neonatal hyperbilirubinemia may be included after consulting with the study clinician.
11. Estimated creatinine clearance (ClCR) <80 mL/min/1.73 m2 (see Section 7.4.1).
12. Subjects whose parents/caregivers are investigational site staff members directly involved in the conduct of the trial or otherwise supervised by the Investigator.
13. Participation in other studies involving investigational drug(s) (Phases 1 4) within 30 days before the current study begins and/or during study participation.
14. Other severe acute or chronic medical, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of the study results or in the judgment of the investigator, would make the subject inappropriate for entry into this study. Patients with complex medical histories, including genetic or chromosomal syndromes, should be discussed with the study clinician prior to screening.
15. The concomitant use of gabapentin, felbamate, and vigabatrin is prohibited.
16. Previous treatment of epilepsy with pregabalin.
17. Weight >30.0 kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified