Trial Outcomes & Findings for Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy (NCT NCT03370120)

Last Updated: 2021-12-29

Results Overview

An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

406 participants

Primary outcome timeframe

From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)

Results posted on

2021-12-29

Participant Flow

The study started to enroll study participants in August 2018 and concluded in December 2020.

Participant Flow refers to the Safety Set. Participants who had completed a padsevonil (PSL) parent study (EP0091 \[NCT03373383\] or EP0092 \[NCT03739840\]) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Padsevonil Participants received padsevonil tablets at a dose of 100 milligrams/day (mg/day) to 800 mg/day up to approximately 2 years.
Overall Study STARTED	406
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	406

Reasons for withdrawal

Reasons for withdrawal
Measure	Padsevonil Participants received padsevonil tablets at a dose of 100 milligrams/day (mg/day) to 800 mg/day up to approximately 2 years.
Overall Study Adverse event, non-fatal	24
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	37
Overall Study Per sponsor's instructions	1
Overall Study Study was terminated by parent company UCB	2
Overall Study The study was ended by the promoter	3
Overall Study Discontinuation of drug development	3
Overall Study End of project	2
Overall Study Premature study closure	2
Overall Study Premature program termination	1
Overall Study Premature study termination	7
Overall Study Trial terminated by sponsor	2
Overall Study Trial discontinued by sponsor	2
Overall Study Study ended	15
Overall Study Clinical trial has been cancelled	1
Overall Study End of study per sponsor decision	2
Overall Study Promoter's decision	2
Overall Study The trial has been suspended	3
Overall Study Sponsor stopped PSL development based on data	3
Overall Study Early termination by order of sponsor	2
Overall Study Discontinuation of the study	5
Overall Study End of clinical trial discontinuation	1
Overall Study Because the clinical trial ended halfway	4
Overall Study Development discontinued	5
Overall Study Padsenovil program closed	3
Overall Study Termination of project	1
Overall Study The study was interrupted by sponsor	4
Overall Study The protocol was interrupted by sponsor	1
Overall Study End of sponsor decision	1
Overall Study The study was terminated prematurely by study lead	1
Overall Study Early termination of studies	5
Overall Study This study is ended early	1
Overall Study End of padsevonil program	2
Overall Study Decision of sponsor	6
Overall Study Asked by the sponsor	3
Overall Study Sponsor decision to stop the protocol	1
Overall Study PI decision poor compliance from participant	1
Overall Study Promoter ended the study	3
Overall Study Premature study close by sponsor's decision	4
Overall Study Study terminated by sponsor	33
Overall Study Sponsor prematurely terminated this study	2
Overall Study Sponsor decision to terminate study	63
Overall Study Program closure	3
Overall Study Study ended prematurely	1
Overall Study Study stopped by sponsor	2
Overall Study Program termination	55
Overall Study Sponsor decision	62
Overall Study Sponsor study closure	10

Baseline Characteristics

Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Padsevonil n=406 Participants Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	395 Participants n=93 Participants
Age, Categorical >=65 years	11 Participants n=93 Participants
Age, Continuous	40.8 years STANDARD_DEVIATION 12.5 • n=93 Participants
Sex: Female, Male Female	231 Participants n=93 Participants
Sex: Female, Male Male	175 Participants n=93 Participants
Race/Ethnicity, Customized American Indian / Alaskan native	5 Participants n=93 Participants
Race/Ethnicity, Customized Asian	38 Participants n=93 Participants
Race/Ethnicity, Customized Black	6 Participants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	5 Participants n=93 Participants
Race/Ethnicity, Customized White	343 Participants n=93 Participants
Race/Ethnicity, Customized Other/mixed	9 Participants n=93 Participants

PRIMARY outcome

Timeframe: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)

Population: The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.

Outcome measures

Outcome measures
Measure	Padsevonil (SS) n=406 Participants Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study	72.2 percentage of participants

PRIMARY outcome

Timeframe: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)

Population: The SS consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.

Outcome measures

Outcome measures
Measure	Padsevonil (SS) n=406 Participants Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal	5.2 percentage of participants

PRIMARY outcome

Timeframe: From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study

Population: Full Analysis Set (FAS) consisted of all enrolled participants who were administered at least 1 dose of PSL or a partial dose of PSL and completed at least 1 seizure diary during the Evaluation Period.

Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.

Outcome measures

Outcome measures
Measure	Padsevonil (SS) n=406 Participants Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).
Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period	-7.73 seizures per 28 days Standard Deviation 27.52

Adverse Events

Padsevonil (SS)

Serious events: 48 serious events

Other events: 184 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Padsevonil (SS) n=406 participants at risk Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Gastrointestinal disorders Abdominal discomfort	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Gastrointestinal disorders Large intestinal haemorrhage	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Gastrointestinal disorders Nausea	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Gastrointestinal disorders Vomiting	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Hepatobiliary disorders Bile duct stone	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Hepatobiliary disorders Cholecystitis	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Hepatobiliary disorders Cholelithiasis	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Corona virus infection	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Cytomegalovirus infection	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Gastroenteritis viral	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Pneumonia	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Wound infection	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Injury, poisoning and procedural complications Head injury	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Injury, poisoning and procedural complications Ulna fracture	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Investigations Mycoplasma test positive	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phyllodes tumour	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Cervical radiculopathy	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Epilepsy	1.7% 7/406 • Number of events 8 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Focal dyscognitive seizures	0.49% 2/406 • Number of events 2 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Generalised tonic-clonic seizure	1.2% 5/406 • Number of events 8 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Migraine	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Partial seizures	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Partial seizures with secondary generalisation	0.49% 2/406 • Number of events 3 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Postictal state	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Seizure	0.99% 4/406 • Number of events 4 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Seizure cluster	0.49% 2/406 • Number of events 2 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Status epilepticus	1.2% 5/406 • Number of events 5 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Syncope	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Psychiatric disorders Aggression	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Psychiatric disorders Suicide Attempt	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Renal and urinary disorders Acute kidney injury	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Renal and urinary disorders Pelvi-ureteric obstruction	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Skin and subcutaneous tissue disorders Drug Eruption	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.49% 2/406 • Number of events 2 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Surgical and medical procedures Hip arthroplasty	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Surgical and medical procedures Vagal nerve stimulator implantation	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Vascular disorders Hypotension	0.25% 1/406 • Number of events 1 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.

Other adverse events

Other adverse events
Measure	Padsevonil (SS) n=406 participants at risk Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
Nervous system disorders Somnolence	16.3% 66/406 • Number of events 76 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Headache	14.5% 59/406 • Number of events 138 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Dizziness	10.6% 43/406 • Number of events 63 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Nervous system disorders Memory impairment	5.2% 21/406 • Number of events 38 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
General disorders Fatigue	11.6% 47/406 • Number of events 56 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Infections and infestations Nasopharyngitis	7.1% 29/406 • Number of events 42 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Psychiatric disorders Insomnia	5.7% 23/406 • Number of events 27 • From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.

Additional Information

UCB

Cares

Phone: 001-844-599-2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60