Trial Outcomes & Findings for Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia (NCT NCT02736955)
NCT ID: NCT02736955
Last Updated: 2018-12-19
Results Overview
Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
60 weeks
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Valbenazine 40 mg
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks
|
Valbenazine 80 mg
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
117
|
8
|
|
Overall Study
COMPLETED
|
29
|
103
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age at diagnosis was not available for some participants.
Baseline characteristics by cohort
| Measure |
Valbenazine 40 mg
n=35 Participants
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 8.9 • n=35 Participants
|
57.9 years
STANDARD_DEVIATION 8.8 • n=117 Participants
|
59.3 years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
57.9 years
STANDARD_DEVIATION 8.8 • n=160 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=35 Participants
|
54 Participants
n=117 Participants
|
3 Participants
n=8 Participants
|
79 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=35 Participants
|
63 Participants
n=117 Participants
|
5 Participants
n=8 Participants
|
81 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=35 Participants
|
52 Participants
n=117 Participants
|
1 Participants
n=8 Participants
|
57 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=35 Participants
|
65 Participants
n=117 Participants
|
7 Participants
n=8 Participants
|
103 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=117 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
1 Participants
n=117 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=35 Participants
|
30 Participants
n=117 Participants
|
3 Participants
n=8 Participants
|
47 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=35 Participants
|
86 Participants
n=117 Participants
|
4 Participants
n=8 Participants
|
111 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=160 Participants
|
|
Body Mass Index (BMI) at Baseline
|
29.15 kg/m^2
STANDARD_DEVIATION 5.52 • n=35 Participants
|
28.54 kg/m^2
STANDARD_DEVIATION 5.48 • n=117 Participants
|
30.55 kg/m^2
STANDARD_DEVIATION 5.29 • n=8 Participants
|
28.77 kg/m^2
STANDARD_DEVIATION 5.46 • n=160 Participants
|
|
Primary Psychiatric Diagnosis
Schizophrenia/schizoaffective disorder
|
23 Participants
n=35 Participants
|
75 Participants
n=117 Participants
|
6 Participants
n=8 Participants
|
104 Participants
n=160 Participants
|
|
Primary Psychiatric Diagnosis
Mood disorder
|
12 Participants
n=35 Participants
|
42 Participants
n=117 Participants
|
2 Participants
n=8 Participants
|
56 Participants
n=160 Participants
|
|
Age at Diagnosis
Schizophrenia/Schizoaffective Disorder
|
27.1 years
STANDARD_DEVIATION 8.3 • n=18 Participants • Age at diagnosis was not available for some participants.
|
28.7 years
STANDARD_DEVIATION 11.4 • n=72 Participants • Age at diagnosis was not available for some participants.
|
25.3 years
STANDARD_DEVIATION 6.2 • n=6 Participants • Age at diagnosis was not available for some participants.
|
28.2 years
STANDARD_DEVIATION 10.6 • n=96 Participants • Age at diagnosis was not available for some participants.
|
|
Age at Diagnosis
Mood Disorder
|
36.0 years
STANDARD_DEVIATION 3.6 • n=11 Participants • Age at diagnosis was not available for some participants.
|
33.9 years
STANDARD_DEVIATION 2.1 • n=42 Participants • Age at diagnosis was not available for some participants.
|
46.0 years
STANDARD_DEVIATION 14.0 • n=2 Participants • Age at diagnosis was not available for some participants.
|
34.7 years
STANDARD_DEVIATION 1.8 • n=55 Participants • Age at diagnosis was not available for some participants.
|
|
Age at Diagnosis
Tardive Dyskinesia
|
48.3 years
STANDARD_DEVIATION 11.2 • n=25 Participants • Age at diagnosis was not available for some participants.
|
48.4 years
STANDARD_DEVIATION 9.5 • n=91 Participants • Age at diagnosis was not available for some participants.
|
43.8 years
STANDARD_DEVIATION 13.7 • n=8 Participants • Age at diagnosis was not available for some participants.
|
48.0 years
STANDARD_DEVIATION 10.1 • n=124 Participants • Age at diagnosis was not available for some participants.
|
|
Scales
BPRS Score
|
27.3 units on a scale
STANDARD_DEVIATION 6.3 • n=35 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
26.1 units on a scale
STANDARD_DEVIATION 5.6 • n=117 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
30.5 units on a scale
STANDARD_DEVIATION 9.2 • n=8 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
26.6 units on a scale
STANDARD_DEVIATION 6.0 • n=160 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
|
Scales
CGI-TD-Severity Score
|
3.9 units on a scale
STANDARD_DEVIATION 1.1 • n=35 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
3.9 units on a scale
STANDARD_DEVIATION 1.3 • n=116 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
4.3 units on a scale
STANDARD_DEVIATION 0.7 • n=8 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
3.9 units on a scale
STANDARD_DEVIATION 1.2 • n=159 Participants • Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
|
PRIMARY outcome
Timeframe: 60 weeksIncidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Outcome measures
| Measure |
Valbenazine 40 mg
n=35 Participants
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Number of Participants Monitored for Long-term Safety of Valbenazine
|
35 Participants
|
117 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 48, and 60Population: Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected.
Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2."
Outcome measures
| Measure |
Valbenazine 40 mg
n=35 Participants
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Baseline
|
2 Participants
|
21 Participants
|
0 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Week 12
|
15 Participants
|
56 Participants
|
3 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Week 24
|
11 Participants
|
56 Participants
|
4 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Week 36
|
7 Participants
|
44 Participants
|
2 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Week 48
|
5 Participants
|
29 Participants
|
2 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Week 60
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 48, and 60Population: Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected.
Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2."
Outcome measures
| Measure |
Valbenazine 40 mg
n=35 Participants
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 Participants
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Baseline
|
35 Participants
|
116 Participants
|
7 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Week 12
|
30 Participants
|
112 Participants
|
6 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Week 24
|
23 Participants
|
92 Participants
|
6 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Week 36
|
17 Participants
|
66 Participants
|
5 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Week 48
|
12 Participants
|
38 Participants
|
5 Participants
|
|
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Week 60
|
2 Participants
|
2 Participants
|
—
|
Adverse Events
Valbenazine 40 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Valbenazine 80 mg
Serious events: 11 serious events
Other events: 23 other events
Deaths: 3 deaths
Valbenazine 40/80 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Valbenazine 40 mg
n=35 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Psychiatric disorders
Aggression
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
2.9%
1/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
12.5%
1/8 • Up to 60 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Infections and infestations
Gangrene
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Nervous system disorders
Coma
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
12.5%
1/8 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/35 • Up to 60 weeks
|
0.85%
1/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
Other adverse events
| Measure |
Valbenazine 40 mg
n=35 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
|
Valbenazine 80 mg
n=117 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
|
Valbenazine 40/80 mg
n=8 participants at risk
Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Up to 60 weeks
|
5.1%
6/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35 • Up to 60 weeks
|
3.4%
4/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Up to 60 weeks
|
2.6%
3/117 • Up to 60 weeks
|
12.5%
1/8 • Up to 60 weeks
|
|
Nervous system disorders
Somnolence
|
2.9%
1/35 • Up to 60 weeks
|
0.00%
0/117 • Up to 60 weeks
|
62.5%
5/8 • Up to 60 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Up to 60 weeks
|
4.3%
5/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Up to 60 weeks
|
3.4%
4/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Up to 60 weeks
|
3.4%
4/117 • Up to 60 weeks
|
0.00%
0/8 • Up to 60 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/35 • Up to 60 weeks
|
2.6%
3/117 • Up to 60 weeks
|
25.0%
2/8 • Up to 60 weeks
|
Additional Information
Neurocrine Medical Information
Neurocrine Biosciences, Inc.
Phone: 877-641-3461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the PI has the right to publish results provided such publication does not violate confidentiality or IP provisions within the contract with the Sponsor. Prior to submission for publication or presentation of results, the PI must provide the Sponsor time for review. The Sponsor can request the PI to withhold or remove information from all publications. For a multi-center study, any publication of results by the PI shall not be made before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER