Trial Outcomes & Findings for Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (NCT NCT04625101)
NCT ID: NCT04625101
Last Updated: 2025-09-05
Results Overview
The ratio of SWI at the end of Week 6 to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-electroencephalograph (EEG) reading using a log base 10 scale. Baseline was defined as the last value measured prior to intake of study treatment on Day 1. SWI was defined as the percentage of seconds with ≥1 spike-wave complex(es) during defined periods of overnight NREM sleep.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
NBI-827104
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
16
|
8
|
|
Overall Study
Full Analysis Set
|
15
|
7
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
NBI-827104
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Baseline characteristics by cohort
| Measure |
NBI-827104
n=16 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=8 Participants
Placebo administered orally daily for up to 13 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Full Analysis Set included all randomized participants who had at least 1 dose of study treatment and at least 1 efficacy video EEG assessment. The number of participants analyzed = the number of participants who were evaluable for this outcome measure.
The ratio of SWI at the end of Week 6 to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-electroencephalograph (EEG) reading using a log base 10 scale. Baseline was defined as the last value measured prior to intake of study treatment on Day 1. SWI was defined as the percentage of seconds with ≥1 spike-wave complex(es) during defined periods of overnight NREM sleep.
Outcome measures
| Measure |
NBI-827104
n=14 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=6 Participants
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Ratio of Spike-Wave Index (SWI) During First Hour of Nonrapid Eye Movement (NREM) Sleep at Week 6
|
-0.02 Log-transformed ratio
Standard Error 0.02
|
0.01 Log-transformed ratio
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Set included all randomized participants who had at least 1 dose of study treatment and at least 1 efficacy video EEG assessment.
The ratio of SWI at the end of Week 12 to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-EEG reading using a log base 10 scale. Baseline was defined as the last value measured prior to intake of study treatment on Day 1. SWI was defined as the percentage of seconds with ≥1 spike-wave complex(es) during defined periods of overnight NREM sleep.
Outcome measures
| Measure |
NBI-827104
n=15 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=7 Participants
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Ratio of SWI During First Hour of NREM Sleep at Week 12
|
-0.05 Log-transformed ratio
Standard Error 0.02
|
0.03 Log-transformed ratio
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: Full Analysis Set included all randomized participants who had at least 1 dose of study treatment and at least 1 efficacy video EEG assessment.
The CaGI-C is a 7-point scale that rates the caregiver's assessment of the overall improvement in the participants symptoms since the initiation of study treatment, ranging from 1 (very much improved) to 7 (very much worse). A responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved).
Outcome measures
| Measure |
NBI-827104
n=15 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=7 Participants
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Number of Participants Considered as Responders as Assessed by the Caregiver Global Impression of Change (CaGI-C) Score
Week 6
|
1 Participants
|
1 Participants
|
|
Number of Participants Considered as Responders as Assessed by the Caregiver Global Impression of Change (CaGI-C) Score
Week 12
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: Full Analysis Set included all randomized participants who had at least 1 dose of study treatment and at least 1 efficacy video EEG assessment.
The CGI-C is a 7-point scale that rates the clinician's assessment of overall improvement in the participant's symptoms since the initiation of study treatment, ranging from 1 (very much improved) to 7 (very much worse). A responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved).
Outcome measures
| Measure |
NBI-827104
n=15 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=7 Participants
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Number of Participants Considered as Responders as Assessed by the Clinician Global Impression of Change (CGI-C) Score
Week 6
|
1 Participants
|
1 Participants
|
|
Number of Participants Considered as Responders as Assessed by the Clinician Global Impression of Change (CGI-C) Score
Week 12
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: Full Analysis Set included all randomized participants who had at least 1 dose of study treatment and at least 1 efficacy video EEG assessment.
The CGI-S is a 7-point scale that rates the clinician's assessment of overall symptom severity, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A responder was defined as a participant with at least 1-point improvement in the CGI-S score from baseline.
Outcome measures
| Measure |
NBI-827104
n=15 Participants
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=7 Participants
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Number of Participants Considered as Responders as Assessed by the Clinical Global Impression of Severity (CGI-S) Scores
Week 6
|
3 Participants
|
1 Participants
|
|
Number of Participants Considered as Responders as Assessed by the Clinical Global Impression of Severity (CGI-S) Scores
Week 12
|
4 Participants
|
4 Participants
|
Adverse Events
NBI-827104
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NBI-827104
n=16 participants at risk
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=8 participants at risk
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
Other adverse events
| Measure |
NBI-827104
n=16 participants at risk
NBI-827104 administered orally daily for up to 13 weeks.
|
Placebo
n=8 participants at risk
Placebo administered orally daily for up to 13 weeks.
|
|---|---|---|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
18.8%
3/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Affect lability
|
12.5%
2/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depressed mood
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Nervous system disorders
Partial seizures
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Cardiac disorders
Tremor
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
12.5%
2/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
25.0%
2/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Otitis media
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Suspected COVID-19
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Infections and infestations
Viral infection
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
0.00%
0/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
3/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
12.5%
1/8 • Day 1 (after dosing) up to Week 17
Safety analysis set included all randomized participants who had at least 1 dose of study treatment.
|
Additional Information
Neurocrine Medical Information
Neurocrine Biosciences
Phone: +1 877-641-3461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place