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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001549-96 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | From Visit 1 (Week 0) to Final Visit (up to Week 158) |
| Percentage of Participants That Withdrew Due to Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | From Visit 1 (Week 0) to Final Visit (up to Week 158) |
| Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| From Visit 1 (Week 0) to Final Visit (up to Week 158) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sp1042 805 | Blagoevgrad | Bulgaria | ||||
| Sp1042 807 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34265173 | Result | Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2. | |
| 34246118 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Safety Set.
The study started to enroll study participants in January 2016 and concluded in January 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2015 | Nov 26, 2020 |
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| Pazardzhik |
| Bulgaria |
| Sp1042 811 | Sofia | Bulgaria |
| Sp1042 205 | Helsinki | Finland |
| Sp1042 207 | Kuopio | Finland |
| Sp1042 236 | Nancy | France |
| Sp1042 263 | Altenburg | Germany |
| Sp1042 265 | Bad Neustadt an der Saale | Germany |
| Sp1042 269 | Leipzig | Germany |
| Sp1042 256 | Marburg | Germany |
| Sp1042 259 | Osnabrück | Germany |
| Sp1042 831 | Asaka | Japan |
| Sp1042 834 | Kagoshima | Japan |
| Sp1042 844 | Kamakura | Japan |
| Sp1042 835 | Nagoya | Japan |
| Sp1042 837 | Okayama | Japan |
| Sp1042 847 | Sapporo | Japan |
| Sp1042 751 | Riga | Latvia |
| Sp1042 547 | San Luis Potosà City | Mexico |
| Sp1042 672 | Pasig | Philippines |
| Sp1042 676 | Quezon | Philippines |
| Sp1042 340 | Katowice | Poland |
| Sp1042 342 | Lublin | Poland |
| Sp1042 343 | Warsaw | Poland |
| Sp1042 576 | Bucharest | Romania |
| Sp1042 570 | Iași | Romania |
| Sp1042 572 | Târgu Mureş | Romania |
| Sp1042 387 | Kazan' | Russia |
| Sp1042 389 | Kazan' | Russia |
| Sp1042 401 | Moscow | Russia |
| Sp1042 392 | Novosibirsk | Russia |
| Sp1042 397 | Saint Petersburg | Russia |
| Sp1042 400 | Saint Petersburg | Russia |
| Sp1042 521 | Daegu | South Korea |
| Sp1042 518 | Daejeon | South Korea |
| Sp1042 517 | Seoul | South Korea |
| Sp1042 519 | Seoul | South Korea |
| Sp1042 440 | Gothenburg | Sweden |
| Sp1042 442 | Linköping | Sweden |
| Sp1042 438 | Stockholm | Sweden |
| Sp1042 651 | Aarau | Switzerland |
| Sp1042 654 | Biel | Switzerland |
| Sp1042 653 | Lugano | Switzerland |
| Sp1042 622 | Chernihiv | Ukraine |
| Sp1042 626 | Kharkiv | Ukraine |
| Sp1042 625 | Odesa | Ukraine |
| Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of study medication in SP1042.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | Posted | Number | percentage of participants | From Visit 1 (Week 0) to Final Visit (up to Week 158) |
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| Primary | Percentage of Participants That Withdrew Due to Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | Posted | Number | percentage of participants | From Visit 1 (Week 0) to Final Visit (up to Week 158) |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | Posted | Number | percentage of participants | From Visit 1 (Week 0) to Final Visit (up to Week 158) |
|
Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide (SS) | Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS). | 1 | 106 | 15 | 106 | 19 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
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| Device Dislocation | General disorders | MedDRA16.1 | Non-systematic Assessment |
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| Sudden Unexplained Death In Epilepsy | General disorders | MedDRA16.1 | Non-systematic Assessment |
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| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
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| Post Gastric Surgery Syndrome | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
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| Arteriogram Coronary | Investigations | MedDRA16.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA16.1 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA16.1 | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA16.1 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
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| Ischaemic Stroke | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
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| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Knee Arthroplasty | Surgical and medical procedures | MedDRA16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2016 | Nov 26, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| C476828 | 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Other/Mixed |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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