Trial Outcomes & Findings for Study to Evaluate NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT05683249)
NCT ID: NCT05683249
Last Updated: 2025-06-03
Results Overview
PERMP is a skill adjusted math test. PERMP-C is the number of math problems answered correctly in a 10-minute session and typically ranges from 0-400 with higher scores indicating better performance. The mean of the post-dose timepoint scores will be used for evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
223 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2025-06-03
Participant Flow
This study was conducted at 9 sites in the United States from 25Feb2023 to 17Jan2024.
A total of 223 participants were enrolled in this study. Participants were randomly assigned to 1 of 2 groups to receive NRCT-101SR or placebo for a 6-week treatment period.
Participant milestones
| Measure |
NRCT-101SR
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
Matching Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
114
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
108
|
114
|
|
Overall Study
COMPLETED
|
83
|
93
|
|
Overall Study
NOT COMPLETED
|
26
|
21
|
Reasons for withdrawal
| Measure |
NRCT-101SR
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
Matching Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Non-compliance with Study Drug
|
2
|
0
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
Study to Evaluate NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
NRCT-101SR
n=108 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=114 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR placebo tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 Years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
36.8 Years
STANDARD_DEVIATION 14.89 • n=7 Participants
|
37.7 Years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Per Protocol Population: all subjects in the mITT population who did not incur a protocol violation that impacted the efficacy evaluation.
PERMP is a skill adjusted math test. PERMP-C is the number of math problems answered correctly in a 10-minute session and typically ranges from 0-400 with higher scores indicating better performance. The mean of the post-dose timepoint scores will be used for evaluation.
Outcome measures
| Measure |
NRCT-101SR
n=81 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=89 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C)
|
21.8 score on a scale
Standard Error 2.17
|
18.9 score on a scale
Standard Error 2.03
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Per Protocol Population: all subjects in the mITT population who did not incur a protocol violation that impacted the efficacy evaluation.
AISRS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with a total score ranging from 0 to 54. Lower scores indicate less severe symptoms.
Outcome measures
| Measure |
NRCT-101SR
n=81 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=89 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS)
|
-12.0 score on a scale
Standard Error 1.24
|
-10.7 score on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population: all subjects who were randomized and were not an extreme outlier for PERMP-C at Week 6.
The BRIEF-A is a standardized self-report measure of executive functions/self-regulation in an everyday environment. It includes 75 items with nine overlapping clinical scales including inhibit, self-monitor, plan/organize, shift, initiate, task monitor, emotional control, working memory, and organization of materials. All items are rated in terms of frequency on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Raw scores for each scale are summed for an overall summary score - the Global Executive Composite (GEC) - and T scores (mean = 50, standard deviation = 10) are determined. Lower scores indicate better executive function. Raw scores are presented here on a scale from 0-150.
Outcome measures
| Measure |
NRCT-101SR
n=89 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=94 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
|
-11.5 score on a scale
Standard Error 2.19
|
-15.6 score on a scale
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population: all subjects who were randomized and were not an extreme outlier for PERMP-C at Week 6.
The HADS consists of 14 items, divided into two 7 item subscales: anxiety (HADS-A) and depression (HADS-D). HADS-A questions reflect a state of generalized anxiety and HADS-D focuses on the concept of anhedonia. Subjects will rate each of the questions on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Scores will be derived by summing responses for each of the two subscales or for the scale as a whole, and the total score is out of 42, with higher scores indicating higher symptom severity. The HADS-A subscale, scored on a scale from 0-21, will be used in the statistical analysis and presented here.
Outcome measures
| Measure |
NRCT-101SR
n=89 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=94 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
|
-1.6 score on a scale
Standard Error 0.38
|
-1.9 score on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population: all subjects who were randomized and were not an extreme outlier for PERMP-C at Week 6.
The AAQoL is a 29-item self-reported scale evaluating aspects of quality of life in ADHD patients. It consists of a total score of 4 subscales, including life productivity, psychological health, life outlook, and relationship. Items are scored on a 5-point scale ranging from 1 (not at all/never) to 5 (extremely/very often). Raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.
Outcome measures
| Measure |
NRCT-101SR
n=90 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=94 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL)
|
10.8 score on a scale
Standard Error 1.53
|
8.4 score on a scale
Standard Error 1.47
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population: all subjects who were randomized and were not an extreme outlier for PERMP-C at Week 6.
The CGI-S is a brief assessment tool that measures clinician's impression of illness severity. Evaluation includes information from the subject and may include information from the subject's medical history, physical exam, or other ratings done at screening. CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Lower scores indicate less severe symptoms.
Outcome measures
| Measure |
NRCT-101SR
n=89 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=95 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression - Severity (CGI-S)
|
-0.9 score on a scale
Standard Error 0.10
|
-0.8 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Per Protocol Population: all subjects in the mITT population who did not incur a protocol violation that impacted the efficacy evaluation.
Responder rate is defined as the proportion of subjects with ≥ 20-point improvement on PERMP-C or ≥ 2-point improvement on CGI-S from Baseline to Week 6.
Outcome measures
| Measure |
NRCT-101SR
n=81 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=89 Participants
Matching Placebo
|
|---|---|---|
|
Responder Rate
|
64.2 percentage of responders
|
60.7 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population: all subjects who were randomized and were not an extreme outlier for PERMP-C at Week 6.
The expanded version of AISRS includes the 18 items of AISRS plus 13 additional items evaluating executive function deficits and emotional dyscontrol. AISRS-EV items are scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with a total score ranging from 0 to 93. Lower scores indicate less severe symptoms
Outcome measures
| Measure |
NRCT-101SR
n=89 Participants
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=95 Participants
Matching Placebo
|
|---|---|---|
|
Change From Baseline in the ADHD Investigator Symptom Rating Scale - Expanded Version (AISRS-EV)
|
-17.1 score on a scale
Standard Error 1.77
|
-15.4 score on a scale
Standard Error 1.72
|
Adverse Events
NRCT-101SR
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NRCT-101SR
n=108 participants at risk
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
|
Placebo
n=114 participants at risk
Matching Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
3.5%
4/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
COVID-19
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Gastroenteritis
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Nervous system disorders
Headache
|
9.3%
10/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
8.8%
10/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
5/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Agitation
|
2.8%
3/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
General disorders
Fatigue
|
3.7%
4/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
7.9%
9/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Viral infection
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Acute sinusitis
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Oral herpes
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Infections and infestations
Subcutaneous abscess
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Nervous system disorders
Sedation
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Dry mouth
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Gastrointestinal disorders
Toothache
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Abnormal dreams
|
1.9%
2/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Insomnia
|
1.9%
2/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Initial insomnia
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Irritability
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Anger
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Depressed mood
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Restlessness
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Suicidal ideation
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
General disorders
Pre-existing condition improved
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
General disorders
Pyrexia
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
General disorders
Thirst
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
2/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Eye disorders
Photophobia
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
1.8%
2/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Eye disorders
Dry eye
|
0.00%
0/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Investigations
Weight increased
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.88%
1/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Vascular disorders
Flushing
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Vascular disorders
Orthostatic hypertension
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Immune system disorders
Seasonal allergy
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
|
Renal and urinary disorders
Urinary retention
|
0.93%
1/108 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
0.00%
0/114 • From signing of informed consent up to approximately Week 7
Safety Population consisted of all participants who received at least 1 dose of study drug. Subjects were analyzed as treated. In the case that a subject was misallocated study drug, they were grouped with active subjects as long as they received any active drug. Data for safety is reported by treatment group (NRCT-101SR and placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This agreement establishes that all protocol information, data, and materials related to Neurocentria's study are confidential and Neurocentria's property. Institution retains ownership of subject medical records but must maintain strict confidentiality, sharing information only with necessary parties bound by the same confidentiality terms. Exceptions include publicly available information, third-party disclosures, previously known information, or independently developed information.
- Publication restrictions are in place
Restriction type: OTHER