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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2010-020730-26-FR |
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Date of registration:
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12/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES
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Scientific title:
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A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES |
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Date of first enrolment:
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08/10/2010 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020730-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: dose-escalation
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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PARTIAL ONSET SEIZURES
MedDRA version: 12.1
Level: LLT
Classification code 10034089
Term: Partial seizures NOS
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Intervention(s)
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Product Name: Pregabalin
Product Code: PD-144723
Pharmaceutical Form: Oral solution
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: PD-0144723
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: • To evaluate the escalating single- and multiple-dose safety and tolerability of pregabalin, in comparison to placebo, in pediatric patients 1 month through 16 years of age with partial onset seizures.
• To evaluate the single-dose and steady-state pharmacokinetics of pregabalin in pediatric patients 1 month through 16 years of age with partial onset seizures.
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Primary end point(s): Safety endpoints will be evaluated throughout the 8 day study period. Data collected on the first 7 days of the study period will be double-blind placebo-controlled. Data collected on Day 8 will be double-blind as to whether subjects are under single-dose conditions (those who received placebo on Days 1 7) or under multiple dose conditions (those who received pregabalin on Days 1 7). Blood samples for pharmacokinetics will be collected beginning on Day 8.
The safety and tolerability data for each age/dose group will be unblinded when data collection is completed for that age/dose group. The evaluation of safety and tolerability of that dose level in that age group will be based on the review of this unblinded data.
3.3.1. Safety Endpoints
Data on the following endpoints will be collected throughout the 8-day study period:
•Frequency and severity of adverse events
•Physical and neurologic exams
•Vital signs
•ECGs
•Laboratory tests: hematology, chemistry (fasting), urinalysis
•Seizure frequency
3.3.2. Pharmacokinetic Endpoints
Serial blood samples and urine collected beginning on Day 8 will be analyzed for pregabalin concentration. The concentration data will be used to assess the following pharmacokinetic parameters:
•AUC(0-24)
•Cmax
•Tmax
•t1/2
•Fraction of dose excreted unchanged in urine.
•CL/F (apparent total clearance)
•CLr (renal clearance)
•Vd/F (apparent volume of distribution)
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Secondary Objective: Not applicable
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 08/10/2010
Contact:
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