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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00291655




Registration number
NCT00291655
Ethics application status
Date submitted
10/02/2006
Date registered
14/02/2006
Date last updated
18/05/2015

Titles & IDs
Public title
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
Scientific title
A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).
Secondary ID [1] 0 0
EUDRACT NUMBER: 2006-000173-29
Secondary ID [2] 0 0
N01237
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

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

Experimental: Levetiracetam (LEV) -


Treatment: Drugs: Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Timepoint [1] 0 0
during open-label therapy phase of 18 months
Secondary outcome [1] 0 0
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Timepoint [1] 0 0
Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

Eligibility
Key inclusion criteria
* Male/female adult subjects (= 16 or 18 years)
* Diagnosis of epilepsy (all types of seizures may be included)
* Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy

Other inclusion criteria may apply
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects withdrawn from N01175 (NCT00175903) trial for any reason
* Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
* Subject requiring add-on antiepileptic treatment
* Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
* Sexually active woman with childbearing potential who is not using a medically accepted birth control method

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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Haine St Paul
Country [5] 0 0
Belgium
State/province [5] 0 0
Jette
Country [6] 0 0
Belgium
State/province [6] 0 0
Kortrijk
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Oostende
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Varna
Country [11] 0 0
Finland
State/province [11] 0 0
Hus (helsinki)
Country [12] 0 0
Finland
State/province [12] 0 0
Kuopio
Country [13] 0 0
Finland
State/province [13] 0 0
Tampere
Country [14] 0 0
France
State/province [14] 0 0
Blaye
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Brest
Country [17] 0 0
France
State/province [17] 0 0
Carcassonne
Country [18] 0 0
France
State/province [18] 0 0
Cherbourg
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Lyon Cedex
Country [21] 0 0
France
State/province [21] 0 0
Nancy
Country [22] 0 0
France
State/province [22] 0 0
Rennes
Country [23] 0 0
France
State/province [23] 0 0
Saint Brieuc
Country [24] 0 0
France
State/province [24] 0 0
Saint Quentin
Country [25] 0 0
France
State/province [25] 0 0
TOULOUSE Cedex 04
Country [26] 0 0
France
State/province [26] 0 0
Valenciennes
Country [27] 0 0
Poland
State/province [27] 0 0
Czestochowa
Country [28] 0 0
Poland
State/province [28] 0 0
Krakow
Country [29] 0 0
Poland
State/province [29] 0 0
Olstyn
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Switzerland
State/province [32] 0 0
Biel
Country [33] 0 0
Switzerland
State/province [33] 0 0
Lausanne
Country [34] 0 0
Switzerland
State/province [34] 0 0
St Gallen
Country [35] 0 0
Switzerland
State/province [35] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
For ethical reasons to give opportunity for adult subjects (=16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
Trial website
https://clinicaltrials.gov/study/NCT00291655
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00291655