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Phase 3 N=219 Randomized Triple-blind Treatment

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.

Generalized Tonic Clonic Seizures

Bottom Line

View on ClinicalTrials.gov: NCT01747915 ↗
Enrolled (actual)
219
Serious AEs
3.2%
Results posted
Aug 2019
Primary outcome: Primary: Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase — 1.17; 1.13; 1.14 Seizure per 28 days — p=0.8121

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Pregabalin Dose Level 1 (Drug); Pregabalin Dose Level 2 (Drug); Placebo (Drug)
Age
Pediatric, Adult, Older Adult · 5+ yrs
Sex
All
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase		 1.17; 1.13; 1.14 0.8121
SECONDARY
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase		 41.3; 38.9; 41.7 0.7973

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01747915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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