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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/NCT02582866




Registration number
NCT02582866
Ethics application status
Date submitted
20/10/2015
Date registered
21/10/2015
Date last updated
6/06/2023

Titles & IDs
Public title
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
Scientific title
A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
Secondary ID [1] 0 0
2015-001549-96
Secondary ID [2] 0 0
SP1042
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 - Lacosamide

Experimental: Lacosamide - Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.
Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.


Treatment: Drugs: Lacosamide
Pharmaceutical Form: Oral tablets
Concentration: 50 mg
Route of Administration: Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Timepoint [1] 0 0
From Visit 1 (Week 0) to Final Visit (up to Week 158)
Primary outcome [2] 0 0
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Timepoint [2] 0 0
From Visit 1 (Week 0) to Final Visit (up to Week 158)
Primary outcome [3] 0 0
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Timepoint [3] 0 0
From Visit 1 (Week 0) to Final Visit (up to Week 158)

Eligibility
Key inclusion criteria
- An Institutional Review Board /Institutional Ethics Committee approved written
Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or
legal representative. The ICF or a specific Assent form, where required, will be
signed and dated by minors

- Subject/legal representative is considered reliable and capable of adhering to the
protocol, visit schedule, and medication intake according to the judgment of the
investigator

- Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been
treated with lacosamide monotherapy
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is receiving any investigational drugs or using any experimental devices in
addition to lacosamide (LCM)

- Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during
SP0994

- Subject required another Anti Epileptic Drug (AED) for the treatment of seizures

- Subject meets a "must" withdrawal criteria for SP0994

- Subject is experiencing an ongoing Serious Adverse Event from SP0994

- Female subject who is pregnant or nursing, and/or a woman of childbearing potential
who is not surgically sterile, 2 year postmenopausal or does not practice one highly
effective method of contraception, unless sexually abstinent, for the duration of the
study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2020
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Blagoevgrad
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Pazardzhik
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Sofia
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Finland
State/province [5] 0 0
Kuopio
Country [6] 0 0
France
State/province [6] 0 0
Nancy
Country [7] 0 0
Germany
State/province [7] 0 0
Altenburg
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Neustadt An Der Saale
Country [9] 0 0
Germany
State/province [9] 0 0
Leipzig
Country [10] 0 0
Germany
State/province [10] 0 0
Marburg
Country [11] 0 0
Germany
State/province [11] 0 0
Osnabruck
Country [12] 0 0
Japan
State/province [12] 0 0
Asaka
Country [13] 0 0
Japan
State/province [13] 0 0
Kagoshima
Country [14] 0 0
Japan
State/province [14] 0 0
Kamakura
Country [15] 0 0
Japan
State/province [15] 0 0
Nagoyashi
Country [16] 0 0
Japan
State/province [16] 0 0
Okayama
Country [17] 0 0
Japan
State/province [17] 0 0
Sapporo
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Daegu
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Daejeon
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Latvia
State/province [21] 0 0
Riga
Country [22] 0 0
Mexico
State/province [22] 0 0
San Luis Potosi
Country [23] 0 0
Philippines
State/province [23] 0 0
Pasig
Country [24] 0 0
Philippines
State/province [24] 0 0
Quezon
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Lublin
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Romania
State/province [28] 0 0
Bucuresti
Country [29] 0 0
Romania
State/province [29] 0 0
Iasi
Country [30] 0 0
Romania
State/province [30] 0 0
Targu Mures
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Kazan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moscow
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Novosibirsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Saint Petersburg
Country [35] 0 0
Sweden
State/province [35] 0 0
Goteborg
Country [36] 0 0
Sweden
State/province [36] 0 0
Linköping
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm
Country [38] 0 0
Switzerland
State/province [38] 0 0
Aarau
Country [39] 0 0
Switzerland
State/province [39] 0 0
Biel
Country [40] 0 0
Switzerland
State/province [40] 0 0
Lugano
Country [41] 0 0
Ukraine
State/province [41] 0 0
Chernihiv
Country [42] 0 0
Ukraine
State/province [42] 0 0
Kharkov
Country [43] 0 0
Ukraine
State/province [43] 0 0
Odesa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma S.P.R.L.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in
patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of
additional monotherapy safety data, and will facilitate access to treatment until commercial
availability for monotherapy use.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02582866
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 Cares
Address 0 0
+1 844 599 2273 (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