Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

NCT00524030 | Terminated Phase 3 Results DMC

• 1 other identifier: A0081047
• Study Type: interventional
• Target: 161
• Locations: 4 countries
• Sites: 73

Brief Summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Conditions

Epilepsies, Partial

Keywords

Epilepsy; partial seizures; pregabalin monotherapy; double-blind and randomized trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

  Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (\>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier \[KM\] product limit estimate for survival function) \* 100%

  Week 2 up to Week 18

Secondary Outcomes (7)

• Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

  Week 2 up to Week 18

• Percentage of Participants Completing 20 Weeks of Double-Blind Treatment

  Randomization up to Week 20

• Percentage of Participants Who Met Protocol-Specified Exit Events

  Week 2 up to Week 18

• Mean Time on Pregabalin Monotherapy

  Week 2 to Week 20

• Percentage of Seizure-Free Participants by Study Phase

  Day 1 up to Day 140

Study Arms (2)

1

EXPERIMENTAL

Drug: pregabalin 600 mg/day

2

EXPERIMENTAL

Drug: pregabalin 150 mg/day

Interventions

pregabalin 600 mg/day DRUG

pregabalin 600 mg/day (300mg BID), duration is 20 weeks.

1

pregabalin 150 mg/day DRUG

pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

2

Eligibility Criteria

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

You may qualify if:

• Diagnosis of epilepsy with partial seizures.
• Males or females, age 18 years or older.
• Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
• Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

You may not qualify if:

• Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
• Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
• Primary generalized epilepsy or status epilepticus within the previous year.

Sponsors & Collaborators

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

Study Sites (73)

Pfizer Investigational Site

Northport, Alabama, 35476, United States

Location

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Phoenix, Arizona, 85003, United States

Location

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Phoenix, Arizona, 85013, United States

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Sun City, Arizona, 85351, United States

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Fayetteville, Arkansas, 72703, United States

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Fullerton, California, 92835, United States

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Long Beach, California, 90806, United States

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Modesto, California, 95355, United States

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Murrieta, California, 92562, United States

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Newport Beach, California, 92660, United States

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Temecula, California, 92591, United States

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Denver, Colorado, 80204, United States

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Jacksonville, Florida, 32209, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33136, United States

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Sarasota, Florida, 34232, United States

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Sarasota, Florida, 34233, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Lawrenceville, Georgia, 30045, United States

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Suwanee, Georgia, 30024, United States

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Anderson, Indiana, 46016, United States

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Danville, Indiana, 46122, United States

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Fort Wayne, Indiana, 46805, United States

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Kansas City, Kansas, 66160, United States

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Bowling Green, Kentucky, 42101, United States

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Lexington, Kentucky, 40536-0284, United States

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Lexington, Kentucky, 40536, United States

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Houma, Louisiana, 70363, United States

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Shreveport, Louisiana, 71105-5634, United States

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Pikesville, Maryland, 21208, United States

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Worcester, Massachusetts, 01605, United States

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Worcester, Massachusetts, 01608, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55422, United States

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Flowood, Mississippi, 39232, United States

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Hattiesburg, Mississippi, 39401-7246, United States

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Great Falls, Montana, 59405, United States

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Cedarhurst, New York, 11516, United States

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Charlotte, North Carolina, 28207, United States

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Charlotte, North Carolina, 28209, United States

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Rocky Mount, North Carolina, 27804, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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Columbus, Ohio, 43210-1250, United States

Location

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Columbus, Ohio, 43210, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oklahoma City, Oklahoma, 73120, United States

Location

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Altoona, Pennsylvania, 16602, United States

Location

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Indiana, Pennsylvania, 15701, United States

Location

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Philadelphia, Pennsylvania, 19140, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77074-2906, United States

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San Antonio, Texas, 78258, United States

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Temple, Texas, 76508, United States

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Murray, Utah, 84107, United States

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Salt Lake City, Utah, 84107, United States

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West Jordan, Utah, 84088, United States

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Milwaukee, Wisconsin, 53226, United States

Location

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Beroun, 266 01, Czechia

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Brno, 602 00, Czechia

Location

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Litomyšl, 570 14, Czechia

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New Territories, Hong Kong

Location

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Dnipropetrovsk, 49027, Ukraine

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Dnipropetrovsk, 49115, Ukraine

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Kharkiv, 61018, Ukraine

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Kharkiv, 61068, Ukraine

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Pfizer Investigational Site

Luhansk, 91045, Ukraine

Location

Pfizer Investigational Site

Odesa, 65025, Ukraine

Location

Related Publications (1)

• French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.

  PMID: 24415567 DERIVED

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

External Data Monitoring Committee (DMC) determined study met criteria to stop early for positive efficacy. Exit rate was the basis for primary analysis and is what is reported here.

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: August 30, 2007
• First Posted: September 3, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 20, 2021
• Results First Posted: May 10, 2012

Record last verified: 2018-12

Locations

CZ (3); UA (6); HK (1); US (63)