Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.

NCT00141427 | Completed Phase 4

• 1 other identifier: A0081005
• Study Type: interventional
• Target: 540
• Locations: 8 countries
• Sites: 56

Brief Summary

To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

• Reduction in seizure frequency.

Interventions

Pregabalin DRUG

Eligibility Criteria

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

You may qualify if:

• Male and female subjects with a diagnosis of partial epilepsy.
• years and older.

You may not qualify if:

• 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 (57)

Pfizer Investigational Site

Bruges, 8000, Belgium

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Brussels, B-1070, Belgium

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Duffel, 2570, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, B-4000, Belgium

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Tielt, 8700, Belgium

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Yvoir, 5530, Belgium

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Helsinki, 00250, Finland

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Kuopio, 70210, Finland

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Tampere, 33520, Finland

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Marseille, Cedex 05, 13005, France

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Montpellier, Cedex 5, 34295, France

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Lyon, Cedex, 69694, France

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Bayonne, 64109, France

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Bordeaux, 33076, France

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Grenoble, 38043, France

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Lille, 59037, France

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Marseille, 13009, France

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Nancy, 54000, France

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Nice, 06031, France

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Paris, 75013, France

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Paris, 75014, France

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Paris, 75019, France

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Rennes, 35033, France

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Strasbourg, 67091, France

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Toulouse, 31403, France

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Tours, 37044, France

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The Hague, South Holland, 2512 VA, Netherlands

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Alkmaar, NL-1815 JD, Netherlands

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Breda, Netherlands

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Heeze, 5591 VE, Netherlands

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Hilversum, NL-1213 XZ, Netherlands

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Oss, 5342 BT, Netherlands

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Southwest Heemstede, 2103, Netherlands

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Katowice, 40-635, Poland

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Krakow, 31-523, Poland

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Lublin, 27-718, Poland

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Warsaw, 00-416, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-957, Poland

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Wroclaw, 50-420, Poland

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Braga, 4701-965, Portugal

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Funchal, 9000-168, Portugal

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Lisbon, 1169-050, Portugal

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Matosinhos Municipality, 4454-509, Portugal

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Ponta Delgada, 9500-370, Portugal

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Porto, 4099-001, Portugal

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Lausanne, CH-1011, Switzerland

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Zurich, 8008, Switzerland

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Zurich, 8091, Switzerland

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Cambridge, Cambs, CB2 2QQ, United Kingdom

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Plymouth, Devon, PL6 8DH, United Kingdom

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Glasgow, G11 6NT, United Kingdom

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Oxford, OX2 6HE, United Kingdom

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Pfizer Investigational Site

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Related Links

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

MeSH Terms

Conditions

Seizures

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; 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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 1, 2005
• Study Start: November 1, 2004
• Study Completion: May 1, 2006
• Last Updated: January 25, 2021

Record last verified: 2006-06

Locations

PT (6); PL (7); CH (3); BE (8); NL (7); FR (17); FI (3); GB (5)