Trial Outcomes & Findings for A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 (NCT NCT02582866)

Last Updated: 2023-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

From Visit 1 (Week 0) to Final Visit (up to Week 158)

Results posted on

2023-06-06

Participant Flow

The study started to enroll study participants in January 2016 and concluded in January 2020.

Participant Flow refers to the Safety Set.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	106
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	7
Overall Study Investigator decision	5
Overall Study Participant wants to get pregnant	1
Overall Study Pregnancy	2
Overall Study Sponsor decision	1
Overall Study Withdrawal due to personal reasons	1

Baseline Characteristics

A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide n=106 Participants 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.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race/Ethnicity, Customized Asian	19 Participants n=5 Participants
Race/Ethnicity, Customized White	86 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Visit 1 (Week 0) to Final Visit (up to Week 158)

Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

Outcome measures

Outcome measures
Measure	Lacosamide (SS) n=106 Participants 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).
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator	59.4 percentage of participants

PRIMARY outcome

Timeframe: From Visit 1 (Week 0) to Final Visit (up to Week 158)

Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

Outcome measures

Outcome measures
Measure	Lacosamide (SS) n=106 Participants 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).
Percentage of Participants That Withdrew Due to Adverse Events (AEs)	0.9 percentage of participants

PRIMARY outcome

Timeframe: From Visit 1 (Week 0) to Final Visit (up to Week 158)

Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.

Outcome measures

Outcome measures
Measure	Lacosamide (SS) n=106 Participants 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).
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator	14.2 percentage of participants

Adverse Events

Lacosamide (SS)

Serious events: 15 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lacosamide (SS) n=106 participants at risk 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).
Cardiac disorders Atrial Flutter	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Cardiac disorders Cardiac Failure	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Cardiac disorders Myocardial Infarction	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Cardiac disorders Ventricular Tachycardia	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Gastrointestinal disorders Diarrhoea	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Gastrointestinal disorders Umbilical Hernia	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
General disorders Device Dislocation	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
General disorders Sudden Unexplained Death In Epilepsy	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Injury, poisoning and procedural complications Forearm Fracture	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Injury, poisoning and procedural complications Post Gastric Surgery Syndrome	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Injury, poisoning and procedural complications Tibia Fracture	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Investigations Arteriogram Coronary	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Metabolism and nutrition disorders Hypoglycaemia	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Musculoskeletal and connective tissue disorders Osteoarthritis	1.9% 2/106 • Number of events 2 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Nervous system disorders Epilepsy	1.9% 2/106 • Number of events 2 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Nervous system disorders Ischaemic Stroke	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Nervous system disorders Peripheral Sensorimotor Neuropathy	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Surgical and medical procedures Knee Arthroplasty	0.94% 1/106 • Number of events 1 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)

Other adverse events

Other adverse events
Measure	Lacosamide (SS) n=106 participants at risk 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).
Infections and infestations Nasopharyngitis	7.5% 8/106 • Number of events 17 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Nervous system disorders Headache	10.4% 11/106 • Number of events 11 • Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60