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Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00150293
Collaborator
(none)
337
Enrollment
84
Locations
44.1
Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Study Start Date :
Mar 1, 2002
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Safety Efficacy []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Must have met the inclusion criteria for preceding double-blind study

  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot be pregnant or considering becoming pregnant during the course of the study.

  • Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Deakin Australian Capital Territory Australia 2600
2 Pfizer Investigational Site Camperdown New South Wales Australia 2050
3 Pfizer Investigational Site Chastwood New South Wales Australia 2067
4 Pfizer Investigational Site Cairns Queensland Australia 4870
5 Pfizer Investigational Site Maroochydore Queensland Australia 4558
6 Pfizer Investigational Site Footscray Victoria Australia 3011
7 Pfizer Investigational Site Parkville Victoria Australia 3050
8 Pfizer Investigational Site Perth Western Australia Australia 6001
9 Pfizer Investigational Site Auenbruggerplatz 22 Austria A-8035 GRAZ
10 Pfizer Investigational Site Graz Austria 8020
11 Pfizer Investigational Site Innsbruck Austria A6020
12 Pfizer Investigational Site Linz Austria 4020
13 Pfizer Investigational Site Wien Austria 1220
14 Pfizer Investigational Site Leuven Belgium 3000
15 Pfizer Investigational Site Calgary Alberta Canada T2N 2T9
16 Pfizer Investigational Site Edmonton Alberta Canada T5G 0B7
17 Pfizer Investigational Site Penticton British Columbia Canada V2A 4V8
18 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 1M9
19 Pfizer Investigational Site Halifax Nova Scotia Canada B3H 3A7
20 Pfizer Investigational Site Barrie Ontario Canada L4M 4S5
21 Pfizer Investigational Site London Ontario Canada N6A 5A5
22 Pfizer Investigational Site Ottawa Ontario Canada K1L 8L6
23 Pfizer Investigational Site Toronto Ontario Canada M5T 2S8
24 Pfizer Investigational Site Windsor Ontario Canada N8X5A6
25 Pfizer Investigational Site Montreal Quebec Canada H1T 2M4
26 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
27 Pfizer Investigational Site Montreal Quebec Canada H3A 2B4
28 Pfizer Investigational Site Regina Saskatchewan Canada S4T 1A5
29 Pfizer Investigational Site Saskatoon Saskatchewan Canada S7N 0W8
30 Pfizer Investigational Site Quebec Canada G1J 1Z4
31 Pfizer Investigational Site Ulm BW Germany 89081
32 Pfizer Investigational Site Berlin Germany BE10362
33 Pfizer Investigational Site Bernau Germany 16321
34 Pfizer Investigational Site Bonn Germany 53127
35 Pfizer Investigational Site Dresden Germany 01307
36 Pfizer Investigational Site Erlangen Germany 91054
37 Pfizer Investigational Site Essen Germany 45147
38 Pfizer Investigational Site Frankfurt Germany HE 60528
39 Pfizer Investigational Site Freiburg Germany 79106
40 Pfizer Investigational Site Goettingen Germany D-37075
41 Pfizer Investigational Site Hamburg Germany D-22337
42 Pfizer Investigational Site Mainz Germany 55101
43 Pfizer Investigational Site Muenchen Germany 81377
44 Pfizer Investigational Site AE Breda Netherlands 4836
45 Pfizer Investigational Site Blaricum Netherlands 1261 AN
46 Pfizer Investigational Site Ve Heeze Netherlands 5591
47 Pfizer Investigational Site Bialystok Poland 15-276
48 Pfizer Investigational Site Bydgoszcz Poland 85-826
49 Pfizer Investigational Site Choroszcz Poland 16-070
50 Pfizer Investigational Site Gdansk Poland 80-211
51 Pfizer Investigational Site Gdansk Poland 82-803
52 Pfizer Investigational Site Grudziadz Poland 86-300
53 Pfizer Investigational Site Katowice Poland 46-645
54 Pfizer Investigational Site Krakow Poland 31-112
55 Pfizer Investigational Site Lublin Poland 20-718
56 Pfizer Investigational Site Mosina Poland 62-050
57 Pfizer Investigational Site Olsztyn Poland 10-561
58 Pfizer Investigational Site Plock Poland 09-402
59 Pfizer Investigational Site Poznan Poland 60-780
60 Pfizer Investigational Site Poznan Poland 61-285
61 Pfizer Investigational Site Torun Poland 87-100
62 Pfizer Investigational Site Warsaw Poland 00-909
63 Pfizer Investigational Site Warsaw Poland 02-957
64 Pfizer Investigational Site Warszawa Poland 00-909
65 Pfizer Investigational Site Warszawa Poland
66 Pfizer Investigational Site Coimbra Portugal 3000-075
67 Pfizer Investigational Site Porto Portugal 4099
68 Pfizer Investigational Site Barcelona Spain 08036
69 Pfizer Investigational Site Girona Spain 17007
70 Pfizer Investigational Site Granada Spain 18013
71 Pfizer Investigational Site Madrid Spain 28034
72 Pfizer Investigational Site Madrid Spain 28040
73 Pfizer Investigational Site Malaga Spain 29010
74 Pfizer Investigational Site Zaragoza Spain 50009
75 Pfizer Investigational Site Middlesborough N. York United Kingdom TS5 5AZ
76 Pfizer Investigational Site Washington Tyne & Wear United Kingdom NE38 9JZ
77 Pfizer Investigational Site Blackpool United Kingdom FY3 8BP
78 Pfizer Investigational Site Dundee United Kingdom DD1 9SY
79 Pfizer Investigational Site Glasgow United Kingdom G11 6NT
80 Pfizer Investigational Site Leeds United Kingdom LS9 7TF
81 Pfizer Investigational Site London United Kingdom E1 1BB
82 Pfizer Investigational Site Northampton United Kingdom NN1 5BD
83 Pfizer Investigational Site Wolverhampton United Kingdom WV10 0QP
84 Pfizer Investigational Site

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00150293
Other Study ID Numbers:
  • 1008-114
First Posted:
Sep 8, 2005
Last Update Posted:
Mar 5, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:
Seizures
Epilepsy
Epilepsies, Partial
Pregabalin

Study Results

No Results Posted as of Mar 5, 2015