Pregabalin In Partial Seizures Extension Study

NCT00143130 | Completed Phase 3

• 1 other identifier: A0081015
• Study Type: interventional
• Target: 227
• Locations: 6 countries
• Sites: 47

Brief Summary

To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Conditions

Seizures

Keywords

phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

Outcome Measures

Primary Outcomes (1)

• Reduction in seizure frequency.

  18 months

Secondary Outcomes (3)

• Seizure-free patients during each 3-month period

  18 Months

• Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).

  18 Months

• Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).

  18 Months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Pregabalin

Interventions

Pregabalin DRUG

Pregabalin

Single Arm

Eligibility Criteria

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

You may not qualify if:

• have completed the 21-week study and have shown a significant clinical response and wish to continue treatment
• Having a treatable cause of seizure.
• Having a progressive neurological or systemic disorder

Sponsors & Collaborators

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

Study Sites (47)

Pfizer Investigational Site

Bruges, B-8000, Belgium

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Duffel, B-2570, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

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Pfizer Investigational Site

Leuven, B-3000, Belgium

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Pfizer Investigational Site

Liège, 4000, Belgium

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Pfizer Investigational Site

Tielt, B-8700, Belgium

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Pfizer Investigational Site

Yvoir, 5530, Belgium

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Pfizer Investigational Site

Helsinki, 00250, Finland

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Pfizer Investigational Site

Kuopio, 70210, Finland

Location

Pfizer Investigational Site

Tampere, 33520, Finland

Location

Pfizer Investigational Site

Paris, Cedex 14, 75674, France

Location

Pfizer Investigational Site

Lille, Cedex, 59037, France

Location

Pfizer Investigational Site

Lyon, Cedex, 69694, France

Location

Pfizer Investigational Site

Marsille, Cedex, 13385, France

Location

Pfizer Investigational Site

Rennes, Cedex, 35033, France

Location

Pfizer Investigational Site

Bayonne, 64109, France

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Pfizer Investigational Site

Bordeaux, 33076, France

Location

Pfizer Investigational Site

Grenoble, 38043, France

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Pfizer Investigational Site

Marseille 13, 13009, France

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Pfizer Investigational Site

Montpellier, 34295, France

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Pfizer Investigational Site

Nancy, 54000, France

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Pfizer Investigational Site

Nice, Cedex 06002, France

Location

Pfizer Investigational Site

Paris, 75019, France

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Paris, 75674, France

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Pfizer Investigational Site

Strasbourg, 67091, France

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Pfizer Investigational Site

Toulouse, 31043, France

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Pfizer Investigational Site

Tours, 37044, France

Location

Pfizer Investigational Site

Katowice, 40-635, Poland

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Pfizer Investigational Site

Krakow, 31-523, Poland

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Lublin, 27-718, Poland

Location

Pfizer Investigational Site

Warsaw, 00-416, Poland

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Pfizer Investigational Site

Warsaw, 02-097, Poland

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Pfizer Investigational Site

Warsaw, 02-957, Poland

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Pfizer Investigational Site

Wroclaw, 50-420, Poland

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Pfizer Investigational Site

Braga, 4701-965, Portugal

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Pfizer Investigational Site

Coimbra, 3000-075, Portugal

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Pfizer Investigational Site

Funchal, 9000-168, Portugal

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Pfizer Investigational Site

Lisbon, Portugal

Location

Pfizer Investigational Site

Matosinhos Municipality, 4454-509, Portugal

Location

Pfizer Investigational Site

Ponta Delgada, 9500-370, Portugal

Location

Pfizer Investigational Site

Ponta Delgada, 9500, Portugal

Location

Pfizer Investigational Site

Porto, 4099-001, Portugal

Location

Pfizer Investigational Site

Lausanne, CH-1011, Switzerland

Location

Pfizer Investigational Site

Zurich, CH-8008, Switzerland

Location

Pfizer Investigational Site

Zurich, CH-8091, Switzerland

Location

Related Links

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

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Pregabalin

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: April 1, 2005
• Study Completion: September 1, 2007
• Last Updated: January 28, 2021

Record last verified: 2015-03

Locations

PL (7); PT (8); FR (18); FI (3); CH (3); BE (8)