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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.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463306
First Posted: November 1, 2011
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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: Masking: None (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 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

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 ]
  • Vital signs [ Time Frame: change from baseline will be assessed at 2, 6, 9 , and 12 months ]
  • 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 ]
  • Clinical laboratory data (hematology , chemistry, urinalysis [ Time Frame: change from baseline will be assessed at 6 and 12 months ]
  • Electrocardiograms [ Time Frame: change from baseline will be assessed at 12 months ]

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

Estimated Enrollment: 400
Actual Study Start Date: February 21, 2012
Estimated Study Completion Date: March 27, 2020
Estimated Primary Completion Date: March 26, 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463306


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 296 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01463306     History of Changes
Other Study ID Numbers: A0081106
2011-001412-65 ( EudraCT Number )
First Submitted: October 17, 2011
First Posted: November 1, 2011
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Seizures
Epilepsies, Partial
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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs