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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.
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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.
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Secondary ID [1]
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1008-114
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Seizure Disorder, Partial
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin
Treatment: Drugs: Pregabalin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety Efficacy
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Assessment method [1]
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Timepoint [1]
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Deakin
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Recruitment hospital [2]
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Pfizer Investigational Site - Camperdown
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Pfizer Investigational Site - Chastwood
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Pfizer Investigational Site - Cairns
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Pfizer Investigational Site - Maroochydore
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Pfizer Investigational Site - Footscray
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Recruitment hospital [7]
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Pfizer Investigational Site - Parkville
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Recruitment hospital [8]
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Pfizer Investigational Site - Perth
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Recruitment postcode(s) [1]
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2600 - Deakin
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2067 - Chastwood
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Recruitment postcode(s) [4]
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4870 - Cairns
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4558 - Maroochydore
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Recruitment postcode(s) [6]
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3011 - Footscray
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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6001 - Perth
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Recruitment outside Australia
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Austria
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Auenbruggerplatz 22
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Bernau
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine long-term safety and efficacy of pregabalin in patients with partial seizures.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00150293
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00150293
Download to PDF