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: 15.0Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 22 August 2016

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 has been informed of all
pertinent aspects of the study. When there are 2 parents or 2 legally acceptable
representatives, consent should be obtained from both of the child’s parents/legal
representatives 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 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 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) Please see appendix 1 of the protocol for additional siezure type inclusions.
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 an EEG within 24 months of
the screening visit. However, if clinical symptoms
have emerged or a change in clinical status has
occurred such that an imaging study would be
required, then a CT or MRI of the head should be
performed regardless 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 by independent reviewer before 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 regimen 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. A previously
implanted Vagus Nerve Stimulator (VNS) for the treatment of epilepsy is allowed and
will be considered one of the 3 antiepileptic treatments.
8. A 12-lead ECG at screening without significant abnormal findings as determined by
the investigator and confirmed by the Central ECG Reader.
Are the trial subjects under 18? yes
Number of subjects for this age r

Exclusion Criteria

1. 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.
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 POS due to fever occurring within
60 days of screening5.. Status epilepticus within 1 year
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 Screening 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 or
psychiatric condition (eg, current major depressive
disorder; schizophrenia or other psychoses) or
laboratory 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, would make the subject inappropriate for
entry into this study.
13 . Pregnant or nursing females (females who are
menarchal must have a negative pregnancy test);
menarchal females of childbearing potential who are
unwilling or unable to use an acceptable method of
contraception from at least 14 days prior to the first
dose of study medication until completion of the study.
14 . Taking any non-antiepileptic (non-AED)
medication that could alter the effectiveness of the
subject’s medication, response, seizure frequency or characteristics. Medications for Attention
Deficit/Hyperactivity Disorder will be permitted if
medication doses are stable and remain so throughout
the duration of study. A ketogenic diet will also be
allowed given that the diet is adhered to for the
duration of the study.
15 . The concomitant use of gabapentin is prohibited.
16 . Use of cocaine, phencyclidine (PCP), or other
illegal or illicit drugs is prohibited. Use of
amphetamines, barbiturates, opiates, or
benzodiazepines without a valid current prescription is
prohibited.
17 . History of lack of efficacy for treatment of
epilepsy with pregabalin at presumed efficacious
doses.
18 . Known allergy or intolerance to pregabalin or its
excipients, including lactose, or other a2d ligands (eg,
gabapentin).
19 . Prior participation in a pregabalin clinical trial.
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 . Participation in other clinical studies within 30
days before the current study begins and/or during
study participation.
25 . Subjects who

Study & Design

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