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

Viatris

Status and phase: Completed; Phase 3

Conditions: Generalized Tonic Clonic Seizures

Treatments: Drug: Placebo; Drug: Pregabalin Dose Level 1; Drug: Pregabalin Dose Level 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747915

2010-023263-18 (EudraCT Number)

A0081105

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: All

Ages: 5 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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219 participants in 3 patient groups, including a placebo group

Study Drug Level 1

Experimental group

Treatment:

Drug: Pregabalin Dose Level 1

Study Drug Level 2

Experimental group

Treatment:

Drug: Pregabalin Dose Level 2

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo