Clinical Study With Lyrica In Patients Suffering From Epilepsy

NCT00922987 | Completed Results

• 1 other identifier: A0081236
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 61

Brief Summary

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

Conditions

Neuralgia; Epilepsy

Keywords

lyrica pregabalin epilepsy partial seizures

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency

  Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency \* 100, divided by the partial seizure frequency at the baseline visit.

  Baseline through week 16 or early termination (ET)

Secondary Outcomes (6)

• Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit

  Baseline and week 16 or ET

• Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study

  Week 4 through week 16 or ET

• Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit

  Baseline, week 4 and week 16 or ET

• Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

  Baseline

• Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit

  Week 16 or ET

Other Outcomes (2)

• Number of Participants With Concomitant Drug Treatments

  Baseline through Week 16 or ET

• Number of Participants With Concomitant Co-morbidities

  Baseline through week 16 or ET

Study Arms (1)

Lyrica

Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics

Drug: Lyrica (pregabalin)

Interventions

Lyrica (pregabalin) DRUG

The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

Lyrica

Eligibility Criteria

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

Study Population

* Adult patiens with partial seizures. * Other inclusion criteria according to Summary of Product Characteristics (SmPC).

You may qualify if:

• Adult patients with partial seizures.

You may not qualify if:

• Contraindications according to Summary of Product Characteristics (SmPC).

Sponsors & Collaborators

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

Study Sites (61)

Pfizer Investigational Site

Banská Bystrica, 97401, Slovakia

Location

Pfizer Investigational Site

Banská Bystrica, 975 17, Slovakia

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Pfizer Investigational Site

Bardejov, 08501, Slovakia

Location

Pfizer Investigational Site

Bojnice, 97201, Slovakia

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Pfizer Investigational Site

Bratislava, 80101, Slovakia

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Pfizer Investigational Site

Bratislava, 81369, Slovakia

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Pfizer Investigational Site

Bratislava, 82606, Slovakia

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Pfizer Investigational Site

Bratislava, 83103, Slovakia

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Pfizer Investigational Site

Bratislava, 83305, Slovakia

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Pfizer Investigational Site

Bratislava, 84104, Slovakia

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Pfizer Investigational Site

Čadca, 02201, Slovakia

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Pfizer Investigational Site

Dolný Kubín, 02601, Slovakia

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Pfizer Investigational Site

Dubnica nad Váhom, 1841, Slovakia

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Pfizer Investigational Site

Dunajská Streda, 92901, Slovakia

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Pfizer Investigational Site

Handlová, 97251, Slovakia

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Pfizer Investigational Site

Hlohovec, 92001, Slovakia

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Pfizer Investigational Site

Humenné, 06601, Slovakia

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Pfizer Investigational Site

Kemarok, 06001, Slovakia

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Pfizer Investigational Site

Komárno, 94501, Slovakia

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Pfizer Investigational Site

Košice, 04001, Slovakia

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Pfizer Investigational Site

Košice, 04011, Slovakia

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Pfizer Investigational Site

Košice, 04012, Slovakia

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Pfizer Investigational Site

Košice, 04015, Slovakia

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Pfizer Investigational Site

Košice, 04086, Slovakia

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Pfizer Investigational Site

Košice, 04190, Slovakia

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Pfizer Investigational Site

Krompachy, 05342, Slovakia

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Pfizer Investigational Site

Levice, 93401, Slovakia

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Pfizer Investigational Site

Levoča, 05401, Slovakia

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Pfizer Investigational Site

Liptovský Mikuláš, 03101, Slovakia

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Pfizer Investigational Site

Malacky, 90122, Slovakia

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Pfizer Investigational Site

Martin, 03601, Slovakia

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Pfizer Investigational Site

Martin, 03659, Slovakia

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Pfizer Investigational Site

Modra, 90001, Slovakia

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Pfizer Investigational Site

Myjava, 90713, Slovakia

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Pfizer Investigational Site

Nitra, 94901, Slovakia

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Pfizer Investigational Site

Nové Mesto nad Váhom, 91501, Slovakia

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Pfizer Investigational Site

Nové Zámky, 94034, Slovakia

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Pfizer Investigational Site

Nové Zámky, 94073, Slovakia

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Pfizer Investigational Site

Piešťany, 92101, Slovakia

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Pfizer Investigational Site

Poltár, 98701, Slovakia

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Pfizer Investigational Site

Prešov, 08001, Slovakia

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Pfizer Investigational Site

Púchov, 2001, Slovakia

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Pfizer Investigational Site

Ružomberok, 03401, Slovakia

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Pfizer Investigational Site

Ružomberok, 03426, Slovakia

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Pfizer Investigational Site

Sereď, 92601, Slovakia

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Pfizer Investigational Site

Skalica, 90982, Slovakia

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Pfizer Investigational Site

Snina, 06901, Slovakia

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Pfizer Investigational Site

Spišská Nová Ves, 05201, Slovakia

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Pfizer Investigational Site

Šahy, 93601, Slovakia

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Pfizer Investigational Site

Šurany, 94218, Slovakia

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Pfizer Investigational Site

Trebišov, 07501, Slovakia

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Pfizer Investigational Site

Trenčín, 91101, Slovakia

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Pfizer Investigational Site

Trnava, 91701, Slovakia

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Pfizer Investigational Site

Trnava, 91775, Slovakia

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Pfizer Investigational Site

Trstená, 02801, Slovakia

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Pfizer Investigational Site

Vranov Nad Toplov, 09327, Slovakia

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Pfizer Investigational Site

Zlaté Moravce, 95301, Slovakia

Location

Pfizer Investigational Site

Zvolen, 86001, Slovakia

Location

Pfizer Investigational Site

Zvolen, 96001, Slovakia

Location

Pfizer Investigational Site

Žilina, 01001, Slovakia

Location

Pfizer Investigational Site

Žilina, 012 07, Slovakia

Location

Related Links

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

MeSH Terms

Conditions

Neuralgia; Epilepsy

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; 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

Limitations and Caveats

On review of blinded data it was decided that an additional analysis set, MFAS was required. MFAS was created for analysis of seizure data. The outcomes related to seizure data were therefore analyzed for MFAS population and not FAS population.

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 25, 2021
• Results First Posted: June 21, 2011

Record last verified: 2011-07

Locations

SL (61)