Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

June 20, 2018 updated by: UCB BIOSCIENCES, Inc.

A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
426

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Capmerdown, New South Wales, Australia
        • 421
      • Chatswood, New South Wales, Australia
        • 425
    • Queensland
      • Herston, Queensland, Australia
        • 423
      • Maroochydore, Queensland, Australia
        • 422
    • South Australia
      • Adelaide, South Australia, Australia
        • 420
    • Victoria
      • Clayton, Victoria, Australia
        • 429
      • Parkville, Victoria, Australia
        • 427
  • Austria
      • Innsbruck, Austria
        • 204
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 127
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 140
    • Ontario
      • Hamilton, Ontario, Canada
        • 116
      • London, Ontario, Canada
        • 93
    • Quebec
      • Greenfield Park, Quebec, Canada
        • 91
      • Montreal, Quebec, Canada
        • 110
      • Montreal, Quebec, Canada
        • 113
  • Denmark
      • Aarhus, Denmark
        • 223
      • Copenhagen, Denmark
        • 220
  • France
      • Bron, France
        • 402
      • Dijon, France
        • 404
      • Ramonville Saint Agne, France
        • 405
  • Germany
      • Berlin, Germany
        • 465
      • Mainz, Germany
        • 461
  • Ireland
      • Dublin, Ireland
        • 240
  • Italy
      • Bologna, Italy
        • 442
      • Catanzaro, Italy
        • 449
      • Ferrara, Italy
        • 443
      • Milano, Italy
        • 441
      • Perugia, Italy
        • 450
      • Pisa, Italy
        • 448
      • Reggio Calabria, Italy
        • 445
      • Torrette Di Ancona, Italy
        • 447
  • Poland
      • Czestochowa, Poland
        • 284
      • Gdansk, Poland
        • 286
      • Gdynia, Poland
        • 282
      • Krakow, Poland
        • 280
      • Lublin, Poland
        • 283
      • Lublin, Poland
        • 290
      • Szczecin, Poland
        • 289
      • Warszawa, Poland
        • 281
      • Warszawa, Poland
        • 287
  • Puerto Rico
      • San Juan, Puerto Rico
        • 158
  • Spain
      • Granada, Spain
        • 323
      • Santa Cruz De Tenerife, Spain
        • 324
  • United Kingdom
      • Blackpool, United Kingdom
        • 360
      • London, United Kingdom
        • 364
      • London, United Kingdom
        • 369
      • Manchester, United Kingdom
        • 361
      • Middlesborough, United Kingdom
        • 363
      • Stoke on Trent, United Kingdom
        • 368
      • Truro, United Kingdom
        • 367
  • United States
    • Alabama
      • Alabaster, Alabama, United States
        • 48
      • Birmingham, Alabama, United States
        • 10
      • Huntsville, Alabama, United States
        • 18
      • Northport, Alabama, United States
        • 42
    • Arizona
      • Phoenix, Arizona, United States
        • 14
      • Phoenix, Arizona, United States
        • 151
      • Phoenix, Arizona, United States
        • 9
      • Sun City, Arizona, United States
        • 150
      • Tucson, Arizona, United States
        • 103
    • Arkansas
      • Jonesboro, Arkansas, United States
        • 102
      • Little Rock, Arkansas, United States
        • 7
      • Little Rock, Arkansas, United States
        • 86
    • California
      • La Habra, California, United States
        • 120
      • Loma Linda, California, United States
        • 156
      • Los Angeles, California, United States
        • 59
      • Los Angeles, California, United States
        • 76
      • Newport Beach, California, United States
        • 45
      • Santa Monica, California, United States
        • 21
      • Torrance, California, United States
        • 107
    • Colorado
      • Aurora, Colorado, United States
        • 60
    • Connecticut
      • Fairfield, Connecticut, United States
        • 25
    • Delaware
      • Dover, Delaware, United States
        • 133
    • District of Columbia
      • Washington, District of Columbia, United States
        • 37
    • Florida
      • Doral, Florida, United States
        • 94
      • Gainesville, Florida, United States
        • 108
      • Gulf Breeze, Florida, United States
        • 130
      • Maitland, Florida, United States
        • 55
      • Miami, Florida, United States
        • 123
      • Miami, Florida, United States
        • 132
      • Orlando, Florida, United States
        • 77
      • Panama City, Florida, United States
        • 49
      • Pinellas Park, Florida, United States
        • 109
      • Port Charlotte, Florida, United States
        • 129
      • Sarasota, Florida, United States
        • 50
      • Sarasota, Florida, United States
        • 81
      • Tallahassee, Florida, United States
        • 4
      • Tampa, Florida, United States
        • 163
    • Georgia
      • Atlanta, Georgia, United States
        • 79
      • Canton, Georgia, United States
        • 72
      • Savannah, Georgia, United States
        • 40
    • Idaho
      • Boise, Idaho, United States
        • 58
    • Illinois
      • Hines, Illinois, United States
        • 131
      • Peoria, Illinois, United States
        • 146
      • Springfield, Illinois, United States
        • 11
    • Indiana
      • Indianapolis, Indiana, United States
        • 78
    • Iowa
      • Ames, Iowa, United States
        • 73
    • Kansas
      • Manhattan, Kansas, United States
        • 124
      • Wichita, Kansas, United States
        • 160
      • Wichita, Kansas, United States
        • 23
    • Kentucky
      • Lexington, Kentucky, United States
        • 119
      • Lexington, Kentucky, United States
        • 164
      • Louisville, Kentucky, United States
        • 62
    • Maine
      • Scarborough, Maine, United States
        • 29
    • Maryland
      • Baltimore, Maryland, United States
        • 20
      • Baltimore, Maryland, United States
        • 34
      • Bethesda, Maryland, United States
        • 19
      • Pikesville, Maryland, United States
        • 65
      • Waldorf, Maryland, United States
        • 137
    • Michigan
      • Detroit, Michigan, United States
        • 41
    • Minnesota
      • Golden Valley, Minnesota, United States
        • 30
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • 71
    • Missouri
      • Chesterfield, Missouri, United States
        • 31
      • Columbia, Missouri, United States
        • 105
      • Saint Louis, Missouri, United States
        • 66
    • Nebraska
      • Omaha, Nebraska, United States
        • 174
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 17
    • New Jersey
      • Edison, New Jersey, United States
        • 43
      • Voorhees, New Jersey, United States
        • 67
    • New York
      • Albany, New York, United States
        • 36
      • Buffalo, New York, United States
        • 83
      • Cedarhurst, New York, United States
        • 69
      • Mineola, New York, United States
        • 154
      • New York, New York, United States
        • 122
      • New York, New York, United States
        • 27
      • Schenectady, New York, United States
        • 175
    • North Carolina
      • Asheville, North Carolina, United States
        • 3
      • Durham, North Carolina, United States
        • 63
      • Rocky Mount, North Carolina, United States
        • 152
      • Wilmington, North Carolina, United States
        • 117
      • Winston-Salem, North Carolina, United States
        • 47
    • Ohio
      • Cleveland, Ohio, United States
        • 15
      • Columbus, Ohio, United States
        • 61
      • Toledo, Ohio, United States
        • 2
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 147
    • Oregon
      • Medford, Oregon, United States
        • 8
      • Portland, Oregon, United States
        • 157
    • Pennsylvania
      • Greensburg, Pennsylvania, United States
        • 100
      • Philadelphia, Pennsylvania, United States
        • 32
      • Tarentum, Pennsylvania, United States
        • 26
    • South Carolina
      • Beaufort, South Carolina, United States
        • 24
    • Tennessee
      • Chattanooga, Tennessee, United States
        • 114
      • Nashville, Tennessee, United States
        • 1
    • Texas
      • Austin, Texas, United States
        • 138
      • Dallas, Texas, United States
        • 111
      • Dallas, Texas, United States
        • 22
      • El Paso, Texas, United States
        • 46
      • Houston, Texas, United States
        • 51
      • Houston, Texas, United States
        • 53
      • San Antonio, Texas, United States
        • 98
      • Temple, Texas, United States
        • 82
    • Utah
      • Layton, Utah, United States
        • 136
    • Virginia
      • Alexandria, Virginia, United States
        • 161
      • Charlottesville, Virginia, United States
        • 16
      • Richmond, Virginia, United States
        • 106
      • Winchester, Virginia, United States
        • 125
    • Washington
      • Renton, Washington, United States
        • 74
    • Wisconsin
      • Madison, Wisconsin, United States
        • 80
      • Milwaukee, Wisconsin, United States
        • 28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
  • Must be experiencing 2 to 40 seizures per 28-day period
  • Stable dose of 1 or 2 marketed antiepileptic drugs
  • Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

  • Subject has a history of primary generalized or unclassified seizures
  • Seizure disorder primarily characterized by isolated auras
  • History of status epilepticus
  • Seizures that are uncountable due to clustering
  • Has greater than 5 seizures/day
  • Subjects taking Benzodiazepines, Phenobarbital or Primidone
  • Subject has Vagus Nerve Stimulation (VNS)
  • Significant medical or psychiatric condition
  • History of alcohol or drug abuse
  • History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lacosamide 400 mg/day
Drug: Lacosamide
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
Drug: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
ACTIVE_COMPARATOR: Lacosamide 300 mg/day
Drug: Lacosamide
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
Drug: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
Time Frame: 16 Weeks Maintenance Period (approximately 112 days)

Pre-defined exit criteria:

  1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase

  2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.

    Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion

  3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
  4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
  5. Status epilepticus, or new onset of serial/cluster seizures
16 Weeks Maintenance Period (approximately 112 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Occurrence of Any Exit Event During The Maintenance Period
Time Frame: 16 Weeks Maintenance Period (approximately 112 days)
The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.
16 Weeks Maintenance Period (approximately 112 days)
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period
Time Frame: 16 Weeks Maintenance Period (approximately 112 days)

Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:

  1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
  2. Withdrawal due to AE with onset during the Maintenance Phase
  3. Withdrew prematurely due to lack of efficacy during the Maintenance Phase

The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.

The secondary analysis is only conducted on the Lacosamide 400 mg/day group.
16 Weeks Maintenance Period (approximately 112 days)
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Time Frame: Visit 9 - Visit 12 (approximately 10 weeks)
Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.
Visit 9 - Visit 12 (approximately 10 weeks)
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Time Frame: Baseline; Last Visit (approximately 27 weeks)

For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Baseline; Last Visit (approximately 27 weeks)
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Time Frame: Baseline; Last Visit (approximately 27 weeks)

For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following:

Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Baseline; Last Visit (approximately 27 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB BIOSCIENCES, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP0902
  • 2007-005439-27 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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