DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-Obvn Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Tonic Clonic Seizures

Intervention: Pregabalin Dose Level 1 (Drug); Pregabalin Dose Level 2 (Drug); Placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial of Pregabalin As Adjunctive Therapy in Pediatric and Adult Subjects With Primary Generalized Tonic Clonic Seizures - Protocol A0081105

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase.

Secondary outcome: Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure.

Eligibility

Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Seizures classified as Primary Generalized Tonic Clonic Seizures

- Must have at least 1 PGTC seizure in the 8 weeks prior to screening

- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least

1 PGTC in each 4-week period of the baseline phase

- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments

(stable within 28 days of screening)

- Signed informed consent and assent if a minor

- Ability to comply with daily seizure and dosing diary requirements and all study

procedures

Exclusion Criteria:

- A current diagnosis of febrile seizures, or seizures related to an ongoing acute

medical illness

- Focal seizures (simple partial, complex partial, or partial becoming secondarily

generalized)

- Status Epilepticus within 1 year prior to screening

- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes

(BECTS) and Dravet syndrome

- Seizures related to drugs, alcohol, or acute medical illness

- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS

alteration) within 28 days of the screening visit or during the baseline phase

- Progressive or potentially progressive structural CNS lesion or a progressive

encephalopathy.

- Progressive inborn errors of metabolism.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2013
Last updated: January 29, 2013

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014