Trial Outcomes & Findings for Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy (NCT NCT01118962)
NCT ID: NCT01118962
Last Updated: 2018-07-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
From Visit 1 to the end of study (Approximately 61 weeks)
Results posted on
2018-07-17
Participant Flow
This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Participant milestones
| Measure |
Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Overall Study
STARTED
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39
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
|
10
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Reasons for withdrawal
| Measure |
Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Overall Study
Adverse Event
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2
|
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Overall Study
Lack of Efficacy
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1
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Overall Study
Protocol Violation
|
1
|
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Pregnancy
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1
|
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Overall Study
Non-compliance with Medicinal Product
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1
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Baseline Characteristics
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Baseline characteristics by cohort
| Measure |
Lacosamide
n=39 Participants
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Age, Categorical
<=18 years
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3 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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36 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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30.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
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Sex: Female, Male
Female
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28 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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Region of Enrollment
United States
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39 participants
n=5 Participants
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Weight
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77.66 Kilograms
STANDARD_DEVIATION 17.58 • n=5 Participants
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Height
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167.88 Centimeters
STANDARD_DEVIATION 8.25 • n=5 Participants
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PRIMARY outcome
Timeframe: From Visit 1 to the end of study (Approximately 61 weeks)Population: Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis. The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).
Outcome measures
| Measure |
Lacosamide
n=39 Participants
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
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37 participants
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PRIMARY outcome
Timeframe: From Visit 1 to the end of study (Approximately 61 weeks)Population: Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis. The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).
Outcome measures
| Measure |
Lacosamide
n=39 Participants
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
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2 participants
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Adverse Events
Lacosamide
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=39 participants at risk
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Infections and infestations
PNEUMONIA
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2.6%
1/39 • Number of events 1 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
CONVULSION
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2.6%
1/39 • Number of events 1 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
MIGRAINE
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2.6%
1/39 • Number of events 1 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Psychiatric disorders
ABNORMAL BEHAVIOUR
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2.6%
1/39 • Number of events 1 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Other adverse events
| Measure |
Lacosamide
n=39 participants at risk
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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|---|---|
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Cardiac disorders
PALPITATIONS
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Eye disorders
DIPLOPIA
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7.7%
3/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Gastrointestinal disorders
NAUSEA
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12.8%
5/39 • Number of events 5 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Gastrointestinal disorders
DIARRHOEA
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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General disorders
FATIGUE
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7.7%
3/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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General disorders
GAIT DISTURBANCE
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Immune system disorders
SEASONAL ALLERGY
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7.7%
3/39 • Number of events 3 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
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25.6%
10/39 • Number of events 13 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Infections and infestations
SINUSITIS
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7.7%
3/39 • Number of events 3 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Infections and infestations
GASTROENTERITIS VIRAL
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5.1%
2/39 • Number of events 3 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Infections and infestations
INFLUENZA
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Infections and infestations
TOOTH ABSCESS
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
FALL
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10.3%
4/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
JOINT SPRAIN
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10.3%
4/39 • Number of events 5 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
CONTUSION
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7.7%
3/39 • Number of events 3 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
EXCORIATION
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
MUSCLE STRAIN
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Injury, poisoning and procedural complications
SKIN LACERATION
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Investigations
WEIGHT INCREASED
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10.3%
4/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Investigations
ALANINE AMINOTRANSFERASE INCREASED
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Investigations
ARTERIAL BRUIT
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Metabolism and nutrition disorders
INCREASED APPETITE
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
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7.7%
3/39 • Number of events 3 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Musculoskeletal and connective tissue disorders
ARTHRALGIA
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5.1%
2/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
DIZZINESS
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25.6%
10/39 • Number of events 12 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
HEADACHE
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17.9%
7/39 • Number of events 12 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
TREMOR
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15.4%
6/39 • Number of events 6 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Nervous system disorders
POSTICTAL STATE
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5.1%
2/39 • Number of events 9 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Psychiatric disorders
ANXIETY
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10.3%
4/39 • Number of events 5 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Psychiatric disorders
CONFUSIONAL STATE
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10.3%
4/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Psychiatric disorders
DEPRESSION
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.3%
4/39 • Number of events 4 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
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5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Skin and subcutaneous tissue disorders
ALOPECIA
|
5.1%
2/39 • Number of events 2 • Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER