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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/NCT00141245




Registration number
NCT00141245
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
1/01/2007

Titles & IDs
Public title
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Scientific title
Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Secondary ID [1] 0 0
1008-012
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 have absence seizures

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
1/10/1998
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
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Deakin
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Chatswood
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
2600 - Deakin
Recruitment postcode(s) [2] 0 0
2067 - Chatswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment postcode(s) [5] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Belgium
State/province [3] 0 0
Duffel
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Finland
State/province [5] 0 0
Turku
Country [6] 0 0
France
State/province [6] 0 0
Cedex
Country [7] 0 0
France
State/province [7] 0 0
Dijon
Country [8] 0 0
France
State/province [8] 0 0
Paris Cedex 13
Country [9] 0 0
France
State/province [9] 0 0
Roubaix
Country [10] 0 0
Germany
State/province [10] 0 0
Erlangen
Country [11] 0 0
Germany
State/province [11] 0 0
Freiburg
Country [12] 0 0
Germany
State/province [12] 0 0
Goettingen
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Mainz
Country [15] 0 0
Germany
State/province [15] 0 0
Moenchengladbach
Country [16] 0 0
Germany
State/province [16] 0 0
Muenster
Country [17] 0 0
Germany
State/province [17] 0 0
Munich
Country [18] 0 0
Italy
State/province [18] 0 0
Firenze
Country [19] 0 0
Italy
State/province [19] 0 0
Pavia
Country [20] 0 0
Italy
State/province [20] 0 0
Perugia
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Netherlands
State/province [22] 0 0
Heemstede
Country [23] 0 0
Netherlands
State/province [23] 0 0
Heeze
Country [24] 0 0
South Africa
State/province [24] 0 0
Cape Town
Country [25] 0 0
South Africa
State/province [25] 0 0
Durban
Country [26] 0 0
Spain
State/province [26] 0 0
Guipuzcoa
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Gerona
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Sweden
State/province [30] 0 0
Goteborg
Country [31] 0 0
Switzerland
State/province [31] 0 0
Lavigny, LE
Country [32] 0 0
Switzerland
State/province [32] 0 0
Tschugg
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Bimingham
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Bucks
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Dundee
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Glasgow
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Liverpool
Country [38] 0 0
United Kingdom
State/province [38] 0 0
York

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

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00141245
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