A long term safety study of pregabalin in children and adults 1 month -65 years of age for add-on epilepsy treatment

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2011-001412-65-GR
• Date of registration: 04/04/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017
• Public title: A long term safety study of pregabalin in children and adults 1 month -65 years of age for add-on epilepsy treatment
• Scientific title: A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
• Date of first enrolment: 19/04/2012
• Target sample size: 330
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001412-65
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Korea, Republic of, Lithuania, Netherlands, Panama, Philippines, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria for Subjects who have Participated in Studies A0081041, A0081042, or A0081105 - Subject eligibility should be reviewed and documented by an appropriately qualified member of investigator’s study team before subjects are included in 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 (or a legally acceptable representative) has been informed of all pertinent aspects of Study A0081106. 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 be obtained.
2. Subjects and/or parents/legally acceptable representative who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male and female subjects who have participated in and completed, or participated in Studies A0081041, A0081042, or A0081105. For subjects who have participated in, but did not complete Studies A0081041, A0081042, or A0081105, eligibility for Study A0081106 will be reviewed with a member of the Pfizer study team to determine further eligibility. Subjects are required to have completed a minimum of 4 weeks of double blind treatment in Studies A0081041 or A0081105 to be considered potentially eligible for Study A0081106.
4. Male and female epilepsy subjects who have participated in either Study A0081041 or Study A0081042, 1 month to 16 years of age inclusive on the date of the Screening Visit with diagnosis of epilepsy with seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE 2010) 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 and EEG testing prior to Study A0081041 or Study A0081042. Results must have been consistent with the diagnosis of focal onset epilepsy and must have demonstrated that no abnormality was likely to be progressive.
5. Male and female subjects 5 65 years of age who have participated in Study A0081105 with a diagnosis of epilepsy (ILAE 2010) with PGTC seizures and who continue to satisfy seizure related inclusion criteria for that study (see Protocol A0081105).
6. Currently receiving 1 to 3 antiepileptic drugs at Visit 1. Benzodiazepine medication used on a regular basis will be considered 1 of the concurrent antiepileptic treatments. The vagus nerve stimulator (VNS) is allowed and considered 1 of the 3 antiepileptic treatments.
7. A 12 lead ECG at (the last visit of Studies A0081041, A0081042, A0081105) without significant abnormal findings.
Inclusion Criteria for Directly Enrolling Subjects (i.e., partial onset seizure subjects who have not participated in either Studies A0081041 or A0081042)
1. Evidence of a p
Exclusion criteria:
1. Lennox Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign epilepsy with centrotemporal spikes) and Dravet syndrome. A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
2. Status epilepticus within 1 year prior to Visit 1 of this study.
3. Seizures related to drugs, alcohol, or acute medical illness.
4. Progressive structural CNS lesion or a progressive encephalopathy. Progressive inborn errors of metabolism.
5. 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). Estimated creatinine clearance (CLcr) <60 mL/min for subjects =17 yr and <80 mL/min/1.73m2 (using age appropriate equations) for subjects <17 years of age.
6. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
7. Pregnant or nursing females (females who are menarchal must have a negative urine 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.
8. 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 the study. A ketogenic diet will also be allowed given that the diet is adhered to for the duration of the study.
9. Taking or have taken any other investigational drug (aside from participation in Studies A0081041, A0081042 or A0081105) within the last 30 days prior to screening.
10. The concomitant use of gabapentin is prohibited.
11. 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.
12. Unwilling or unable to comply with the Life Style Guidelines.
13. Subjects not reasonably expected to complete the study.
14. Any subjects considered at risk of suicide based on the MINI KID and C SSRS Lifetime (subjects =6 years of age) or CBCL (subjects <6 years of age) or likely to self harm based on clinical judgment. Based on the judgment of the investigator, a subject should be excluded or a risk assessment should be done by a qualified mental health professional based on responses to suicidality assessments and if the subject has had suicidal ideation in the last 6 months prior to screening, suicidal behaviors or attempts in the past year, or current major psychiatric disorders that are not explicitly

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

Health Condition(s) or Problem(s) studied

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

Partial onset seizures and Primary Generalised Tonic Clonic Seizures
MedDRA version: 14.1 Level: LLT Classification code 10034089 Term: Partial seizures NOS System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Lyrica
Product Name: Pregabalin
Pharmaceutical Form: Oral solution
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-

Trade Name: Lyrica®
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD-144,723
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Lyrica®
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD-144,723
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: Lyrica®
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD-144,723
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Lyrica®
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD-144,723
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type: equal

Primary Outcome(s)

Secondary Objective: There are no Secondary Objectives in this study

Timepoint(s) of evaluation of this end point: Various endpoints throughout the study

Main Objective: To evaluate the long term safety and tolerability of pregabalin in pediatric subjects 1 month through 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with (PGTC) seizures.

Primary end point(s): • Adverse event (AE) data (occurrence, nature, intensity, and relationship to study drug).
• Physical and neurological examinations.
• Vital signs.
• Growth and development parameters (height, weight, Tanner stage).
• Clinical laboratory data (hematology, chemistry, urinalysis).
• Electrocardiograms (ECGs).
• 28 day seizure rate (number of seizures per 28 day period).
• Suicidality assessments.
•Cognitive assessment battery (POS pediatric subjects 4 16 years of age only).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: None

Secondary end point(s): None

Secondary ID(s)

2011-001412-65-HU

A0081106

Source(s) of Monetary Support

Pfizer Inc

Ethics review

Status: Approved
Approval date:
Contact: