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-BE
• Date of registration: 31/01/2012
• 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: 09/08/2012
• Target sample size: 400
• 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: no; 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, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Netherlands, Panama, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

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:

For Subjects who have Participated in Studies A0081041, A0081042, or A0081105
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. The diagnosis must be established by:
•Subject's history 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 electroencephalogram (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 with PGTC seizures and who continue to satisfy seizure related inclusion criteria for that study. Subjects who have participated in study A0081105 and who reach the age limit of 66 years of age will still be allowed to enter this study.
6. Currently receiving a stable dose of 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.

For Directly Enrolling Subjects (who have not participated in either Studies A0081041 or A0081042). In order for Direct Enrolling Subjects to be eligible, all of the following inclusion criteria must be met and confirmed prior to, or on, Visit 2:
1. see item 1 above
2. see item 2 above
4. Male and female epilepsy subjects, 1 month
Exclusion criteria:
1. Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures for Direct Enrolling subjects, BECT and Dravet syndrome. A current diagnosis of febrile seizures, any febrile seizures within 1 year of screening, or seizures related to an ongoing acute medical illness. Prior history of febrile seizures may be allowed on a case by case basis following consultation with study clinician.
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. For subjects who previously participated in A0081041, A0081042 or A0081105, it is assumed the subjects have already met entry criteria, therefore, the creatinine clearance exclusion is based upon results collected at the Screening Visit laboratory of A0081041, A0081042 or A0081105. The laboratory exclusion criteria noted above will be based upon data collected at the Last visit of the A0081041, A0081042 or A0081105
6. Other severe acute or chronic medical (eg, genetic or chromosomal syndromes) 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 or the sponsor, 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)
8. Taking any non-AED medication that could alter the effectiveness of the subject's medication, response, seizure frequency or characteristics. Medications for Attention Deficit/Hyperactivity Disorder and other behavioral changes will be permitted. A ketogenic diet will also be allowed given that the diet is adhered to for the duration of the study. Note: changes in the dose, regimen and type of these medications during study participation may be allowed upon discussion with the study clinician. Continued participation of the subject will be evaluated and decided on a case-by-case basis
9. Taking or have taken any other investigational drug (aside from Studies A0081041, A0081042 or A0081105) within the last 30 days prior to screening
10. The concomitant use of gabapentin, felbamate and vigabatrin is prohibited
11. Use of cocaine, phencyclidine (PCP), or other illegal or illicit drugs is prohibited. Use of marijuana, or its derivatives, including prescribed medical marijuana, is not allowed under any circumstances. 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


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: 17.0 Level: LLT Classification code 10034089 Term: Partial seizures NOS System Organ Class: 100000004852

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

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).

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

Secondary Outcome(s)

Secondary end point(s): None

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

Secondary ID(s)

2011-001412-65-HU

A0081106

Source(s) of Monetary Support

Pfizer Inc

Ethics review

Status: Approved
Approval date:
Contact: