A 12-MONTH OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES
- Conditions
- PARTIAL ONSET SEIZURESMedDRA version: 12.1Level: LLTClassification code 10034089Term: Partial seizures NOS
- Registration Number
- EUCTR2010-020731-39-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
- 54
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male and female subjects who have completed protocol A0081074 and who have a minimum weight of 3.5 kg. For subjects who do not complete protocol A0081074, eligibility for protocol A0081075 will be considered on a case by case basis.
2. Seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, according to the International League against Epilepsy 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. A 12 lead ECG at baseline without significant abnormal findings.
4. Patients 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.
5. 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:
6. Primary (eg, absence epilepsy) or secondary (eg, Lennox Gastaut syndrome, infantile spasms, myoclonic or atonic epilepsies) generalized epilepsy.
7. Seizures related to drugs, alcohol, or acute medical illness.
8. Progressive structural CNS lesion or a progressive encephalopathy. Progressive inborn errors of metabolism.
9. 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).
10. Known or suspected white blood cell counts below 3000/mm3; absolute neutrophil counts of less than 1500/mm3, or platelet counts of less than 100x10 to the power of 3/mm3.
11. 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.
12. 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, until completion of follow-up procedures.
13. Any condition possibly affecting drug absorption (eg, gastrectomy).
14. 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 is prohibited.
15. Taking or have taken any other investigational drug within the last 30 days prior to screening.
16. A positive urine drug screen for non therapeutic drugs.
17. Unwilling or unable to comply with the Lifestyle Guidelines.
18. Use of tobacco- or nicotine containing products.
19. Patients 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 Main Objective: To evaluate the long term safety and tolerability of pregabalin in pediatric patients 1 month through 16 years of age with partial onset seizures.;Secondary Objective: Not applicable;Primary end point(s): Safety and tolerability will be evaluated at each study visit. Data on the following endpoints will be collected:<br>•Frequency and severity of adverse events<br>•Physical and neurologic exams<br>•Vital signs<br>•Growth parameters (height, weight; body mass index will be calculated from height and weight)<br>•ECGs<br>•Laboratory tests: hematology, chemistry, urinalysis, endocrine panel, creatine phosphokinase<br>•Seizure frequency (number of seizures per 28 day period).<br>
- Secondary Outcome Measures
Name Time Method