A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On 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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01463306
First received: October 17, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on 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. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.


Condition Intervention Phase
Epilepsy, Partial Seizures
Epilepsy, Primary Generalized Tonic-Clonic Seizures
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month Open-Label Study To Evaluate The Safety And Tolerability Of Pregabalin As Adjunctive Therapy In Children 1 Month To 16 Years Of Age With Partial Onset Seizures And Child And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • SAE's (serious adverse event) and AE's (adverse events) [ Time Frame: continuously for up to one year ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: change from baseline will be assessed at 2, 6, 9 , and 12 months ] [ Designated as safety issue: Yes ]
  • Physical exams to assess change from baseline for physical state of limbs, torso, and organs and Neurological exams to assess change from baseline for measures of peripheral and central nervous system function. [ Time Frame: change from baseline will be assessed at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Clinical laboratory data (hematology , chemistry, urinalysis [ Time Frame: change from baseline will be assessed at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: change from baseline will be assessed at 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Suicidality assessments [ Time Frame: every visit for up to 1 year ] [ Designated as safety issue: Yes ]
  • Cognitive testing [ Time Frame: change from baseline will be assessed at 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open
Pregabalin open label flexible dose
Drug: Pregabalin
Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
Other Name: Lyrica

  Eligibility

Ages Eligible for Study:   1 Month to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.
  • Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
  • Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
  • Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
  • Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

  • Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
  • A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
  • Status epilepticus within 1 year prior to visit 1.
  • Seizures related to drugs, alcohol, or acute medical illness.
  • Progressive structural CNS lesion or a progressive encephalopathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463306

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 115 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01463306     History of Changes
Other Study ID Numbers: A0081106
Study First Received: October 17, 2011
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
safety
partial onset seizures
primary generalized tonic-clonic seizures
pregabalin
pediatric
adult
open-label
long term

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014