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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00150293




Registration number
NCT00150293
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
5/03/2015

Titles & IDs
Public title
Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Scientific 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.
Secondary ID [1] 0 0
1008-114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seizure Disorder, Partial 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin

Treatment: Drugs: Pregabalin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Efficacy
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Deakin
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Chastwood
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Cairns
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Footscray
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Parkville
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2600 - Deakin
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2067 - Chastwood
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4558 - Maroochydore
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Auenbruggerplatz 22
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Nova Scotia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Canada
State/province [12] 0 0
Saskatchewan
Country [13] 0 0
Germany
State/province [13] 0 0
BW
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Bernau
Country [16] 0 0
Germany
State/province [16] 0 0
Bonn
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Erlangen
Country [19] 0 0
Germany
State/province [19] 0 0
Essen
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt
Country [21] 0 0
Germany
State/province [21] 0 0
Freiburg
Country [22] 0 0
Germany
State/province [22] 0 0
Goettingen
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Mainz
Country [25] 0 0
Germany
State/province [25] 0 0
Muenchen
Country [26] 0 0
Netherlands
State/province [26] 0 0
AE Breda
Country [27] 0 0
Netherlands
State/province [27] 0 0
Blaricum
Country [28] 0 0
Netherlands
State/province [28] 0 0
Ve Heeze
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystok
Country [30] 0 0
Poland
State/province [30] 0 0
Bydgoszcz
Country [31] 0 0
Poland
State/province [31] 0 0
Choroszcz
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Grudziadz
Country [34] 0 0
Poland
State/province [34] 0 0
Katowice
Country [35] 0 0
Poland
State/province [35] 0 0
Krakow
Country [36] 0 0
Poland
State/province [36] 0 0
Lublin
Country [37] 0 0
Poland
State/province [37] 0 0
Mosina
Country [38] 0 0
Poland
State/province [38] 0 0
Olsztyn
Country [39] 0 0
Poland
State/province [39] 0 0
Plock
Country [40] 0 0
Poland
State/province [40] 0 0
Poznan
Country [41] 0 0
Poland
State/province [41] 0 0
Torun
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Portugal
State/province [44] 0 0
Coimbra
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Girona
Country [48] 0 0
Spain
State/province [48] 0 0
Granada
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Malaga
Country [51] 0 0
Spain
State/province [51] 0 0
Zaragoza
Country [52] 0 0
United Kingdom
State/province [52] 0 0
N. York
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Tyne & Wear
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Blackpool
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Dundee
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Glasgow
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Leeds
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Northampton
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Wolverhampton
Country [61] 0 0
State/province [61] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine long-term safety and efficacy of pregabalin in patients with partial seizures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00150293
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries