Epilepsies, PartialPhase 1/2NCT00437281

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

A Phase 1/2 study testing Pregabalin in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications. Read more about this study

Who is it for?: Ages 1 month to 16 years
Conditions the study is for: Epilepsies, Partial
What is being tested?: Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 18 sitesin 3 countries
Study dates: Apr 2007to Nov 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Partial onset seizures, incompletely controlled on 1-3 medications
At least 1 seizure per 28 days, on average

Who cannot join

Primary generalized seizures
Progressive CNS pathology

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

United States15 sites

Pfizer Investigational Site
Buffalo, New York, 14222
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Gulf Breeze, Florida, 32561
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Mobile, Alabama, 36604
Pfizer Investigational Site
Mobile, Alabama, 36693
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Springfield, Missouri, 65804
Pfizer Investigational Site
Tampa, Florida, 33603
Pfizer Investigational Site
Tampa, Florida, 33609

Other trials in United States

Mexico2 sites

Pfizer Investigational Site
Guadalajara, Jalisco, 44280
Pfizer Investigational Site
Mexico City, Mexico City, 06720

Other trials in Mexico

South Korea1 site

Pfizer Investigational Site
Seoul, 120-752

Other trials in South Korea

About this study

Official title: A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Conditions: Epilepsies, Partial
Being tested: Placebo, Pregabalin
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Medical subject headings: Epilepsies, Partial, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo
PregabalinDrug
Orally-administered pregabalin

Study groups in NCT00437281
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Pregabalin	Experimental	Not described Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Measured: Baseline to Day 7
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Measured: Day 8 up to 28 days after open-label dose of study medication

Secondary outcomes (14)

Number of Participants With Clinically Significant Change in Physical and Neurological Findings
Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.
Measured: Baseline up to 7 days post-last dose of study medication
28-Day Seizure Frequency Rate
Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)*28.
Measured: Baseline up to 7 days post-last dose of study medication
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis
Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis
Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Single-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Multiple-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Single-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Renal Clearance (CLr): Multiple-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Measured: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Renal Clearance (CLr): Single-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).
Measured: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Nov 2012

First posted19 Feb 2007 (estimated)
Study startApr 2007
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00437281
Sponsor's protocol ID: A0081074
Status last verified: Jan 2014
First submitted: 16 Feb 2007
Last updated: 11 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mann D, Liu J, Chew ML, Bockbrader H, Alvey CW, Zegarac E, Pellock J, Pitman VW. Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: a phase 1, randomized controlled study. Epilepsia. 2014 Dec;55(12):1934-43. doi: 10.1111/epi.12830. Epub 2014 Nov 6.
PubMed 25377429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Epilepsies, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
ClinicalTrials.gov ID: NCT00437281
Acronym / sponsor ID: A0081074
Conditions: Epilepsies, Partial
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 19 Feb 2007 (estimated)
Results: Posted 17 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Pregabalin	Experimental	Drug: Pregabalin

Who may qualify

Ages: 1 month to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Partial onset seizures, incompletely controlled on 1-3 medications
At least 1 seizure per 28 days, on average

Key exclusion criteria (2 listed)

Primary generalized seizures
Progressive CNS pathology

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo	Drug	Placebo
PregabalinOrally-administered pregabalin	Drug	Pregabalin

Primary outcome

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
Time frame: Baseline to Day 7
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
Time frame: Day 8 up to 28 days after open-label dose of study medication
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.

14 secondary outcomes

Number of Participants With Clinically Significant Change in Physical and Neurological Findings
Time frame: Baseline up to 7 days post-last dose of study medication
28-Day Seizure Frequency Rate
Time frame: Baseline up to 7 days post-last dose of study medication
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Plasma Decay Half-Life (t1/2): Single-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Multiple-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Apparent Oral Clearance (CL/F): Single-Dose Analysis
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Renal Clearance (CLr): Multiple-Dose Analysis
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Renal Clearance (CLr): Single-Dose Analysis
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8

Results and safety

Results posted to the registry on 17 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)	3	3
Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)	3	3
Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)	3	3
Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)	3	2
Placebo (Age Cohort: 1 to 23 Months)	4	4
Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)	4	3
Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)	3	3
Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)	3	3
Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)	3	3
Placebo (Age Cohort: 2 to 6 Years)	5	4
Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)	3	3
Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)	3	3
Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)	2	2
Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)	3	2
Placebo (Age Cohort: 7 to 11 Years)	5	4
Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)	3	3
Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)	3	3
Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)	4	4
Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)	2	1
Placebo (Age Cohort: 12 to 16 Years)	3	2

Primary outcome: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment

Time frame: Baseline to Day 7. Number. Unit: adverse events

Measure	Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Placebo (Age Cohort: 1 to 23 Months) n = 4	Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 4	Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Placebo (Age Cohort: 2 to 6 Years) n = 5	Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 2	Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Placebo (Age Cohort: 7 to 11 Years) n = 5	Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 4	Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 2	Placebo (Age Cohort: 12 to 16 Years) n = 3
Mild	0	2	2	4	1	1	4	5	5	13	0	3	3	5	2	0	2	11	2	0
Moderate	1	1	0	1	1	2	0	0	0	3	2

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment

Time frame: Day 8 up to 28 days after open-label dose of study medication. Number. Unit: adverse events

Measure	Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) n = 3	Placebo (Age Cohort: 1 to 23 Months) n = 4	Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 4	Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) n = 3	Placebo (Age Cohort: 2 to 6 Years) n = 5	Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 2	Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) n = 3	Placebo (Age Cohort: 7 to 11 Years) n = 5	Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 3	Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 3	Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 4	Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) n = 2	Placebo (Age Cohort: 12 to 16 Years) n = 3
Mild	0	0	0	1	2	0	0	0	0	1	0	0	1	0	0	0	0

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)	0 of 3 (0%)	3 of 3 (100%)	Not reported
Placebo (Age Cohort: 1 to 23 Months)	0 of 4 (0%)	2 of 4 (50%)	Not reported
Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)	0 of 4 (0%)	2 of 4 (50%)	Not reported
Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Placebo (Age Cohort: 2 to 6 Years)	0 of 5 (0%)	4 of 5 (80%)	Not reported
Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)	0 of 3 (0%)	3 of 3 (100%)	Not reported
Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)	0 of 2 (0%)	2 of 2 (100%)	Not reported
Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)	1 of 3 (33.3%)	2 of 3 (66.7%)	Not reported
Placebo (Age Cohort: 7 to 11 Years)	1 of 5 (20%)	2 of 5 (40%)	Not reported
Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Limitations and caveats (from the sponsor): Results are reported for AUCtau for multiple-dose PK analysis and AUC (0-∞) for single-dose PK analysis, instead of AUC (0-24), as per change in planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25377429Mann D, Liu J, Chew ML, Bockbrader H, Alvey CW, Zegarac E, Pellock J, Pitman VW. Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: a phase 1, randomized controlled study. Epilepsia. 2014 Dec;55(12):1934-43. doi: 10.1111/epi.12830. Epub 2014 Nov 6.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pregabalin in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Mexico, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment (time frame: Baseline to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00437281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.