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Trial details imported from ClinicalTrials.gov

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

Summary results
Other publications