A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES
- Conditions
- PARTIAL ONSET SEIZURESMedDRA version: 12.1Level: LLTClassification code 10034089Term: Partial seizures NOS
- Registration Number
- EUCTR2010-020730-26-FR
- Lead Sponsor
- Pfizer Inc.235 East 42nd Street, New York, NY 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male and female epilepsy patients, age 1 month (44 weeks gestational age) to 16 years inclusive, with a minimum body weight of 3.5 kg.
2. Seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Classification of Seizures. Partial onset seizures must be diagnosed in either of two ways:
a. Clinical observation of partial seizures with focal semiology confirmed by and consistent with the localization of either:
• Focal epileptiform abnormality on EEG within the last 2 years, or
• Focal abnormality on imaging; or
b. Seizure recorded by EEG monitoring which fulfills the ILAE criteria for EEG seizure type within the last 2 years.
3.Must have a partial seizure frequency of at least 1 seizure per 28 day month prior to enrollment.
4. Currently receiving a stable dosage of 1 to 3 antiepileptic drugs (stable within 7 days of screening), with blood levels within typically accepted therapeutic range. Benzodiazepine medication used at a stable dosage and frequency for rescue treatment will be considered one of the concurrent antiepileptic treatments.
5. A head CT scan with contrast, or MRI of the brain (at any time prior to study participation), demonstrating no abnormality that is likely to be progressive, and no clinical evidence of a progressive abnormality.
6. A 12 lead ECG at screening without significant abnormal findings.
7. Subjects and parents/legal guardians must be thought to be compliant and able to follow the investigator’s instructions. They must be able to visit the clinic on schedule and be both cooperative and reliable.
8. Parents/legal guardians must give written informed consent prior to the start of the study. Consent should be obtained from both (if available) of the child’s legal representatives (parents or guardians). Whenever the minor child is able to give assent, the minor’s assent must be obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following will not be included in the trial:
1. A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 6 months of screening.
2. Primary (eg, absence epilepsy) or secondary (eg, Lennox-Gastaut syndrome, infantile spasms, myoclonic or atonic epilepsies) generalized epilepsy.
3. Seizures related to drugs, alcohol, or acute medical illness.
4. Any change in AED regimen during the last 7 days prior to screening.
5. Progressive structural CNS lesion or a progressive encephalopathy. Progressive inborn errors of metabolism.
6. Known or suspected chronic hematologic, hepatic or renal disease (AST and ALT above 3 times the upper limit of normal; or bilirubin, BUN, or creatinine above 2 times the upper limit of normal within the previous 6 months for infants, children and adolescents aged 6 months or more, or at any postnatal period for infants younger than 6 months).
7. Known or suspected white blood cell counts below 3000/mm3; absolute neutrophil counts of less than 1500/mm3, or platelet counts of less than 100x103/mm3.
8. Estimated creatinine clearance (ClCR) <80 mL/min/1.73m2. The Cockcroft Gault equation normalized for body surface area will be used for estimating creatinine clearance for ages 12-16 years. Creatinine clearance (in units of ml/min/1.73m2) will be estimated for the younger children using the following equations:
ClCR = 0.45×length (cm)/serum creatinine (mg/dL), for infants 1 to <12 months old;
ClCR = 0.55×length (cm)/serum creatinine (mg/dL), for children 1 to <12 years old.
9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
10. Pregnant or nursing females (females age 10 or greater, or 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, as outlined in the protocol, from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures.
11.Any condition possibly affecting drug absorption (eg, gastrectomy).
12.Taking any non-antiepileptic (non-AED) medication that could alter the effectiveness of the patient’s medication, response, seizure frequency or characteristics. The use of gabapentin, felbamate, vigabatrin, or agents with central nervous system activity within 1 week of screening, and throughout the study, is prohibited.
13. Taking or have taken any other investigational drug within the last 30 days prior to screening.
14. A positive urine drug screen for non-therapeutic drugs (subjects testing positive will not be randomized).
15. Unwilling or unable to comply with the Lifestyle Guidelines.
16. Use of tobacco- or nicotine-containing products.
17. Previous use of pregabalin.
18. History of sensitivity to heparin or heparin-induced thrombocytopenia.
19. Not reasonably expected to complete the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method