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Clinical Study With Lyrica In Patients Suffering From Epilepsy

NCT ID: NCT00922987

Last Updated: 2021-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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\- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Conditions

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Neuralgia Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lyrica

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

Lyrica (pregabalin)

Intervention Type 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)

Interventions

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Lyrica (pregabalin)

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients with partial seizures.

Exclusion Criteria

* Contraindications according to Summary of Product Characteristics (SmPC).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Banská Bystrica, , Slovakia

Site Status

Pfizer Investigational Site

Banská Bystrica, , Slovakia

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Bardejov, , Slovakia

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Čadca, , Slovakia

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Dolný Kubín, , Slovakia

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Dubnica nad Váhom, , Slovakia

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Dunajská Streda, , Slovakia

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Handlová, , Slovakia

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Hlohovec, , Slovakia

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Humenné, , Slovakia

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Kemarok, , Slovakia

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Komárno, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Krompachy, , Slovakia

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Levice, , Slovakia

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Levoča, , Slovakia

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Liptovský Mikuláš, , Slovakia

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Malacky, , Slovakia

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Martin, , Slovakia

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Martin, , Slovakia

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Modra, , Slovakia

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Myjava, , Slovakia

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Nitra, , Slovakia

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Nové Mesto nad Váhom, , Slovakia

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Nové Zámky, , Slovakia

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Nové Zámky, , Slovakia

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Piešťany, , Slovakia

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Poltár, , Slovakia

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Prešov, , Slovakia

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Púchov, , Slovakia

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Ružomberok, , Slovakia

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Ružomberok, , Slovakia

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Sereď, , Slovakia

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Skalica, , Slovakia

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Snina, , Slovakia

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Spišská Nová Ves, , Slovakia

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Šahy, , Slovakia

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Šurany, , Slovakia

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Trebišov, , Slovakia

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Trenčín, , Slovakia

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Trnava, , Slovakia

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Trnava, , Slovakia

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Trstená, , Slovakia

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Vranov Nad Toplov, , Slovakia

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Zlaté Moravce, , Slovakia

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Zvolen, , Slovakia

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Zvolen, , Slovakia

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Žilina, , Slovakia

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Pfizer Investigational Site

Žilina, , Slovakia

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Countries

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Slovakia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081236&StudyName=Clinical%20Study%20With%20Lyrica%20In%20Patients%20Suffering%20From%20Epilepsy

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

Other Identifiers

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A0081236

Identifier Type: -

Identifier Source: org_study_id

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