Pregabalin Versus Levetiracetam In Partial Seizures

NCT00537238 | Completed Phase 3 Results DMC

• 1 other identifier: A0081157
• Study Type: interventional
• Target: 509
• Locations: 20 countries
• Sites: 70

Brief Summary

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Conditions

Partial Seizures

Keywords

Epilepsies partial; Partial Seizure Disorder; Complex Partial Seizure Disorder; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Response to Treatment

  Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.

  Baseline up to Week 16

Secondary Outcomes (7)

• Percent Change From Baseline in 28 Day Seizure Frequency at Week 16

  Baseline, Week 16

• Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16

  Baseline, Week 16

• Percentage of Participants Without Seizures

  Baseline up to Week 16

• Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up

  Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)

• Hospital Anxiety and Depression Scale (HADS) Score

  Baseline, Week 16

Study Arms (2)

B

ACTIVE COMPARATOR

Drug: pregabalin

A

ACTIVE COMPARATOR

Drug: levetiracetam

Interventions

pregabalin DRUG

300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

B

levetiracetam DRUG

1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects (male or female) must be \> 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
• Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
• Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

You may not qualify if:

• Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
• Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (72)

Pfizer Investigational Site

Duffel, B-2570, Belgium

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Yvoir, B-5530, Belgium

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Kyustendil, Bulgaria

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Pernik, 2300, Bulgaria

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Plovdiv, 4000, Bulgaria

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Rousse, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1407, Bulgaria

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Barranquilla, Atlántico, 0, Colombia

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Bogota, Cundinamarca, 0, Colombia

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Montes de Oca, Provincia de San José, Costa Rica

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San José, Costa Rica

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Brno, 602 00, Czechia

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Hradec Králové, 500 03, Czechia

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Olomouc, 775 20, Czechia

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Ostrava-Trebovice, 772 00, Czechia

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Prague, 140 59, Czechia

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Příbram, 26195, Czechia

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Rychnov nad Kněžnou, 516 01, Czechia

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Strasbourg, 67091, France

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Toulouse, 31043, France

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Bonn, 53105, Germany

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Hamburg, 22083, Germany

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Athens, 11521, Greece

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Thessaloniki, 57010, Greece

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Pune, Maharashtra, 411 004, India

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Chandigarh, Punjab, 160 012, India

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Ludhiana, Punjab, 141 008, India

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Florence, 50125, Italy

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Foggia, 71100, Italy

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Pisa, 56126, Italy

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Siena, 53100, Italy

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Kaunas, 50009, Lithuania

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Vilnius, 08661, Lithuania

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Distrito Federal, 14269, Mexico

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San Luis Potosí City, 78223, Mexico

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Panama City, Panama

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Lima, L 11, Peru

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Lima, Lima 1, Peru

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Tondo, Manila, 1000, Philippines

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Cebu City, 6000, Philippines

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Davao City, 8000, Philippines

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Makati City, 1200, Philippines

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Manila, 1000, Philippines

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Quezon City, 1100, Philippines

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Moscow, 107150, Russia

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Moscow, 125367, Russia

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Moscow, 129128, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Busan, 602-715, South Korea

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Daejeon, 301-721, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Donostia / San Sebastian, Guipuzcoa, 20014, Spain

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Alicante, 03010, Spain

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Barcelona, 08035, Spain

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Córdoba, 14008, Spain

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Girona, 17007, Spain

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Seville, 41071, Spain

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Kaohsiung City, 807, Taiwan

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Taichung, 407, Taiwan

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Tainan, 704, Taiwan

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Çapa, Istanbul, 34390, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Cerrahpasa / Istanbul, 34098, Turkey (Türkiye)

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Caracas, Libertador, 1010, Venezuela

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Caracas, Miranda, 1080-A, Venezuela

Location

Related Publications (1)

• Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

  PMID: 24902473 DERIVED

MeSH Terms

Conditions

Seizures; Epilepsies, Partial; Epilepsy, Complex Partial; Epilepsy

Interventions

Pregabalin; Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Acetates; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Results for BPRS were provided as change in scores at Week 16 compared to baseline instead of absolute scores as per planned analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: July 11, 2013

Record last verified: 2013-05

Locations

BU (6); RU (6); GR (2); ME (2); TU (3); CZ (7); LI (2); KR (7); FR (2); IT (4); CO (2); IN (3); PH (6); ES (6); DE (2); PE (2); VE (2); TW (3); PA (1); BE (2)