Trial Outcomes & Findings for Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older (NCT NCT01236001)

NCT ID: NCT01236001

Last Updated: 2013-08-08

Results Overview

Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.

Recruitment status

COMPLETED

Target enrollment

192 participants

Primary outcome timeframe

Baseline

Results posted on

2013-08-08

Participant Flow

This observational study began enrollment in September 2010. The last patient visit occurred in March 2012. There were 22 study sites in Belgium.

The Safety Set (SS) and Full Analysis Set (FAS) both consisted of 192 subjects. The SS consisted of all enrolled subjects who received at least one dose of VIMPAT (before or during the study). The FAS consists of all enrolled subjects.

Participant milestones

Participant milestones
Measure	Patients Treated With VIMPAT® Prior to Enrollment Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment.
Overall Study STARTED	105	87
Overall Study COMPLETED	87	65
Overall Study NOT COMPLETED	18	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Treated With VIMPAT® Prior to Enrollment Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment.
Overall Study Adverse Event	5	14
Overall Study Lack of Efficacy	6	6
Overall Study Lost to Follow-up	6	1
Overall Study Incompliance	1	0
Overall Study Planned Visit After End of Study	0	1

Baseline Characteristics

Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=87 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	81 Participants n=7 Participants	178 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	40.1 years STANDARD_DEVIATION 13.4 • n=5 Participants	43.3 years STANDARD_DEVIATION 14.0 • n=7 Participants	41.5 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	52 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	35 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Belgium	105 participants n=5 Participants	87 participants n=7 Participants	192 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.

Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment.	Total Population Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Mean Total Daily Dose of VIMPAT® (mg) at Baseline	272.1 mg/day of Vimpat Standard Deviation 114.4	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=74 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=63 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=137 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months	316.2 mg/day of Vimpat Standard Deviation 106.7	211.1 mg/day of Vimpat Standard Deviation 77.4	267.9 mg/day of Vimpat Standard Deviation 107.7

PRIMARY outcome

Timeframe: 6 months

Population: Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=87 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=67 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=154 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months	329.9 mg/day of Vimpat Standard Deviation 119.5	262.7 mg/day of Vimpat Standard Deviation 103.9	300.6 mg/day of Vimpat Standard Deviation 117.5

PRIMARY outcome

Timeframe: Baseline

Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.

This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment.	Total Population Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline Tablet	104 participants	—	—
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline Oral Solution	1 participants	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.

VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=74 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=63 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=137 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months Tablet	74 participants	63 participants	137 participants
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months Oral Solution	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 6 months

Population: Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.

VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=87 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=67 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=154 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months Tablet	87 participants	67 participants	154 participants
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months Oral Solution	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From baseline to study termination (6 months)

Population: Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.

Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=87 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=192 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment	98.1 percentage of patients	96.6 percentage of patients	97.4 percentage of patients

SECONDARY outcome

Timeframe: >=6 months

Population: Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.

Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (\>=6 months).

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=87 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=192 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Treatment Persistence of VIMPAT® After 6 Months	95.2 percentage of participants	56.3 percentage of participants	77.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.

This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=105 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment.	Total Population Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline Much Improved	16.2 percentage of participants	—	—
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline Improved	39.0 percentage of participants	—	—
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline Stable	30.5 percentage of participants	—	—
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline Worsened	2.9 percentage of participants	—	—
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline Unknown	11.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.

Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=78 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=74 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=152 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months Much improved	16.7 percentage of participants	16.2 percentage of participants	16.4 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months Improved	43.6 percentage of participants	33.8 percentage of participants	38.8 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months Stable	34.6 percentage of participants	35.1 percentage of participants	34.9 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months Worsened	5.1 percentage of participants	9.5 percentage of participants	7.2 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months Unknown	0 percentage of participants	5.4 percentage of participants	2.7 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.

Outcome measures

Outcome measures
Measure	Patients Treated With VIMPAT® Prior to Enrollment n=95 Participants Patients who started VIMPAT® treatment before enrollment.	Patients Who Started VIMPAT® Treatment on/After Enrollment n=73 Participants Patients who started VIMPAT® treatment on/after enrollment.	Total Population n=168 Participants Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months Much improved	18.9 percentage of participants	19.2 percentage of participants	19.0 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months Improved	35.8 percentage of participants	38.4 percentage of participants	36.9 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months Stable	40.0 percentage of participants	34.2 percentage of participants	37.5 percentage of participants
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months Worsened	5.3 percentage of participants	8.2 percentage of participants	6.5 percentage of participants

Adverse Events

Vimpat® Treatment

Serious events: 8 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vimpat® Treatment n=192 participants at risk Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
Blood and lymphatic system disorders Eosinophilia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
General disorders Pyrexia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Infections and infestations Meningitis herpes	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Status epilepticus	1.6% 3/192 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Convulsion	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Dizziness	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	Vimpat® Treatment n=192 participants at risk Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
Blood and lymphatic system disorders Thrombocytopenia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Cardiac disorders Tachycardia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	2.6% 5/192 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Eye disorders Diplopia	2.6% 5/192 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Eye disorders Dry eye	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Eye disorders Vision blurred	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	4.7% 9/192 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal hypermotility	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Gastrointestinal disorders Hypoaesthesia oral	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
General disorders Fatigue	7.3% 14/192 • Number of events 14 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
General disorders Gait disturbance	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
General disorders Irritability	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
General disorders Oedema peripheral	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural headache	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Investigations Liver function test abnormal	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Metabolism and nutrition disorders Anorexia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Metabolism and nutrition disorders Increased appetite	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Dizziness	9.9% 19/192 • Number of events 19 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Somnolence	4.7% 9/192 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Headache	3.6% 7/192 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Ataxia	2.1% 4/192 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Disturbance in attention	1.6% 3/192 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Cognitive disorder	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Tremor	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Dysarthria	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Dysphasia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders Facial paresis	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Nervous system disorders VIth nerve paralysis	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Confusional state	2.1% 4/192 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Depressed mood	1.6% 3/192 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Abnormal dreams	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Agitation	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Depressive symptom	1.0% 2/192 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Acute stress disorder	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Aggression	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Conduct disorder	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Decreased interest	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Initial insomnia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Middle insomnia	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Obsessive-compulsive disorder	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Psychotic disorder	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Psychiatric disorders Sleep walking	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	1.6% 3/192 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Vascular disorders Hot flush	0.52% 1/192 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.

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.
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