Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00141245