A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 years of age with Partial Onset seizures.

• Register: EUCTR
• Last refreshed on: 6 April 2020
• Main ID: EUCTR2013-003420-37-BG
• Date of registration: 07/01/2016
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017
• Public title: A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 years of age with Partial Onset seizures.
• Scientific title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 1 MONTH THROUGH <4 YEARS OF AGE WITH PARTIAL ONSET SEIZURES - Pregabalin, Phase 3 Study in children < 4 years of age with partial onset seizures
• Date of first enrolment: 28/01/2016
• Target sample size: 123
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003420-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, China, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
- Subject must have 3 partial onset seizures in the month prior to screening.
- Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- Signed Informed Consent
- On 1-3 stable anti-eplieptic drugs at screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 123
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:
- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms
- Lennox-Gasteau, BECTS, and Dravet's syndrome
- Status epliepticus within 1 year of screening
- Any change in AED regimen with 7 days of screening
- Progressive structural central nervous system (CNS) lesion or a progressive encepholopathy
- Progressive errors of metabolism


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Partial onset seizures
MedDRA version: 19.0 Level: LLT Classification code 10034089 Term: Partial seizures NOS System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Lyrica
Product Name: Pregabalin
Pharmaceutical Form: Oral solution
INN or Proposed INN: PREGABALIN
CAS Number: 148553-50-8
Current Sponsor code: PD-144,723
Other descriptive name: PREGABALIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1 month through <4 years of age.

Secondary Objective: To evaluate the efficacy of pregabalin compared to placebo on the frequency of partial onset seizures as determined by responder rate in pediatric subjects 1 month through <4 years of age.

To assess the safety and tolerability of pregabalin in pediatric subjects 1 month (44 weeks gestational age) through <4 years of age with partial onset seizures.

Timepoint(s) of evaluation of this end point: Visit 6

Primary end point(s): The primary endpoint will be the log transformed double blind 24 hr seizure rate for all partial onset seizures collected at Visit 6 (48 hour Video-EEG assessment phase) during the double blind phase as determined by the central reader. This 24-hour seizure rate will be calculated as follows for the double-blind period:

Double Blind 24 - hr EEG seizure rate = # of seizures in double blind 48 - hr assessment phase \ # of hours of Video - EEG monitoring x 24

When the log-transformation is used, the quantity 1/28 is added to the double blind 24-hr EEG seizure rate for all subjects to account for any possible "0" seizure incidence. This will result in the following primary efficacy measure: log e (double blind 24-hr EEG seizure rate +1/28). Results will be reported as “percent change in seizures” relative to placebo.

A minimum of 24 hours of evaluable Video-EEG will be required to utilize the EEG. In cases where there is less than 24 hours of evaluable Video-EEG, the seizure rate will be set to missing.

The baseline 24-hr EEG seizure rate will be calculated in the same respective manner.

Secondary Outcome(s)

Secondary end point(s): Responder Rate, defined as subjects who have a =50% reduction from baseline in partial seizure rate during the double-blind 48 hour Video-EEG phase. Subjects meeting this criterion will be considered responders.

The evaluation of safety will include adverse event (AE) data (occurrence, nature, intensity, and relationship to study drug), assessment of clinical laboratory data and the results of physical examinations, vital signs, weight, neurological examinations, and electrocardiograms (ECGs).

Timepoint(s) of evaluation of this end point: Visit 2 - visit 7

Secondary ID(s)

A0081042

2013-003420-37-BE

Source(s) of Monetary Support

Pfizer Inc

Ethics review

Status: Approved
Approval date: 20/01/2016
Contact:

Results

• Results available: Yes
• Date Posted: 23/09/2018
• Date Completed: 13/03/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003420-37/results