A safety and efficacy study of pregabalin in children 4-16 years of age for partial onset seizures

Phase 1

• Conditions: Partial onset seizures; MedDRA version: 18.0Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020852-79-BG
• Lead Sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that
the subject and/or parent/legally acceptable representative or guardian has been informed of all
pertinent aspects of the study. When there are two parents or two legally acceptable
representatives or guardians, consent should be obtained from both of the child’s parents/legal
representatives or guardians if present at the meeting where the informed consent document is signed. Subject to local regulations whenever the minor is able to give assent, the minor’s assent must also be obtained.
2. Subjects and/or parent(s)/legally acceptable representative or guardian who are willing and able to
comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Subjects and/or parent(s)/legally acceptable representative or guardian must be considered willing
and able to complete daily seizure diaries and monitor seizure frequency.
4. Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the
Screening Visit.
5. 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)3 Diagnosis must be established by:
- Subject’s history (eg, description of seizures excluding confounding disorders such as pseudoseizures, syncopes etc) family history and neurological exam.
- Subjects must have had a contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain within 60 months of the Screening Visit and EEG testing within 24 months of the Screening Visit.However, if clinical symptoms have emerged or a change in clinical status has occured such that an imaging study would be required, then a CT with contrast or MRI of the head should be performed regardsless of the amount of time that has elapsed since the previous CT// MRI scan.Results must be available as soon as possible following screening and must be completed and reviewed prior to randomization. Imaging results must be consistent with the
diagnosis of focal-onset epilepsy and must demonstrate that no abnormality is
likely to be progressive.
- Confirmation of diagnosis and seizure classification by the Pfizer designated external reviewer prior to randomization.
6. 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 =6 seizures and no
continuous 4 week seizure free period during the 8 week baseline phase prior to
randomization.
7. Currently receiving a stable dose of 1 to 3 antiepileptic treatments (stable within 28 days
prior to screening). Benzodiazepine medication used on a regular basis at a stable
dosage will be considered 1 of the concurrent antiepileptic treatments.Any as needed (PRN) benzodiazepine use in addition to AEDs must be discussed with the Pfizer clinician and allowance will be decided on a case-by case basis. A previously
implanted Vagus nerve stimulator (VNS) for the treatment of epilepsy is allowed and
will be considered one of the 3 antiepileptic treatments. A ketonic diet is allowed but not considered

Exclusion Criteria

1.Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include for ex: 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 any febrile seizures within 1 yr of screening, or seizures related to an ongoing acute medical illness. Prior hist (ie, more than 1 yr prior to screen) of febrile seizures may be allowed on a case by case basis following consultation with the study clinician.4.Exacerbation of POS due to fever occurring within 60 days of screen.5.Status epilepticus within 1 yr prior to screening.6.Seizures related to drugs, alcohol, or acute medical illness.7 Any change in AED regimen (type of medication or dose) within 28 days of the Screen Visit or during the Baseline Phase.8.Progressive structural 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).11.Estimated creatinine clearance (ClCR) <80 mL/min/1.73 m2. 12.Other severe acute or chronic medical (eg. genetic or chromosomal syndromes) or psychiatric condition (eg, current major depressive disorder;schizophrenia or other psychoses) or lab abnormality that may increase the risk associated with study participation or study medication administration or may interfere with the interpretation of the study results and, in the judgment of the investigator or sponsor, would make the subj inappropriate for entry into this study.13.Pregnant female subjs; breastfeeding female subjs; male subjs with partners currently pregnant; male and female subjs of childbearing potential who are unwilling or unable to use highly effective method of contraception from at least 14 days prior to the 1st dose of study medication until 28 days after the last dose of investigational product.14. Taking any non-antiepileptic (non-AED) medication that could alter the effectiveness of the subj’s medication, response, seizure frequency or characteristics. Medications for Attention Deficit/Hyperactivity Disorder and other behavioral disorders (eg, risperidone) will be permitted if medication doses are stable and remain so throughout the duration of study.15.The concomitant use of gabapentin, felbamate and vigabatrin is prohibited. 16.Use of cocaine, phencyclidine (PCP), or other illegal or illicit drugs is prohibited. Use of marijuana, or its derivatives, including prescribed medical marijuana, is not allowed under any circumstances. Use of amphetamines, barbiturates, opiates, or benzodiazepines without a valid current prescription is prohibited. 17.Hist of lack of efficacy for treatment of epilepsy with pregabalin at presumed efficacious doses.18.Known allergy or intolerance to pregabalin or other a2d ligands (eg, gabapentin). 20. Treatment with pregabalin for any reason within 60 days prior to screening. 21. History of sensitivity to heparin or heparin induced thrombocytopenia. 22. Unwilling or unable to comply with the Life Style Guidelines. 23. Not reasonably expected to complete the trial.
24. Participat

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified