Trial Outcomes & Findings for BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder (NCT NCT03193398)
NCT ID: NCT03193398
Last Updated: 2021-05-11
Results Overview
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34 indicate moderate depression, and from 35 to 60 indicate severe depression.
COMPLETED
PHASE2
104 participants
Week 8
2021-05-11
Participant Flow
Total of 104 subjects were randomized for the study NEP-MDD-201
Participant milestones
| Measure |
BTRX-246040
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 12.29 • n=93 Participants
|
42.6 years
STANDARD_DEVIATION 15.00 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 13.72 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islanders
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34 indicate moderate depression, and from 35 to 60 indicate severe depression.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo
|
-15.0 Change in score on a scale from baseline
Standard Error 1.73
|
-13.6 Change in score on a scale from baseline
Standard Error 1.79
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered MADRS-6 subscale focuses on the core symptoms of depression and assesses the following symptoms: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 36. The change from baseline in the Investigator-administered MADRS-6 subscale was analyzed using the same method as the MADRS efficacy endpoint, substituting the baseline MADRS-6 subscale as the covariate in place of the MADRS total score.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change From Baseline in Investigator-administered MADRS-6 Total Score
|
-10.7 Change in score on a scale from baseline
Standard Error 1.17
|
-9.7 Change in score on a scale from baseline
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered Hospital Anxiety and Depression Scale (HADS) subscales comprises of 7 questions regarding Depression and 7 questions regarding Anxiety. Each question is rated on a scale from 0 - 3. The outcome of the HADS questionnaire is two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score
|
-2.6 Change in score on a scale from baseline
Standard Error 0.67
|
-3.5 Change in score on a scale from baseline
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered Hospital Anxiety and Depression Scale (HADS) subscales comprises of 7 questions regarding Depression and 7 questions regarding Anxiety. Each question is rated on a scale from 0 - 3. The outcome of the HADS questionnaire is two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score
|
-5.0 Change in score on a scale from baseline
Standard Error 0.76
|
-5.9 Change in score on a scale from baseline
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered Dimensional Anhedonia Rating Scale (DARS) is a 17-item questionnaire with each answer between 0 and 4 on a Likert scale grading (0=Not at all, 1=Slightly, 2=Moderately, 3=Mostly, 4=Very Much). Therefore, the DARS total score is on a scale of 0 - 68. The DARS Total score is broken down into four dimensions; Hobbies, Food/Drink, Social Activities and Sensory Experience.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)
|
13.7 Change in score on a scale from baseline
Standard Error 16.7
|
2.91 Change in score on a scale from baseline
Standard Error 3.04
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment
The Investigator-administered Snaith Hamilton Pleasure Scale (SHAPS) is a 14-item questionnaire. The SHAPS is scored two different ways. Under the original scoring method, each question has 4 responses, 2 of which imply agreement (Definitely Agree, Agree; each scored as 0) and 2 which imply disagreement (Disagree, Strongly Disagree; each scored as 1). Therefore, the SHAPS total score ranges 0 - 14. In this study, in addition to the traditional scoring method, an alternative scoring method will assign 1 - Strongly Agree, 2 - Agree, 3 - Disagree, and 4 - Strongly Disagree. Using this alternative scoring method, the total score ranges 14-56. In both scoring systems, higher scores indicate greater anhedonia.
Outcome measures
| Measure |
BTRX-246040
n=52 Participants
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=50 Participants
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score
|
-6.7 Change in score on a scale from baseline
Standard Error 1.24
|
-7.9 Change in score on a scale from baseline
Standard Error 1.28
|
Adverse Events
BTRX-246040
Placebo
Serious adverse events
| Measure |
BTRX-246040
n=53 participants at risk
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=51 participants at risk
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
Other adverse events
| Measure |
BTRX-246040
n=53 participants at risk
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks
|
Placebo
n=51 participants at risk
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
15.1%
8/53 • Up to week 10
|
25.5%
13/51 • Up to week 10
|
|
Nervous system disorders
Somnolence
|
5.7%
3/53 • Up to week 10
|
13.7%
7/51 • Up to week 10
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Nervous system disorders
Paraesthesia
|
3.8%
2/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Nervous system disorders
Disturbance In Attention
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Nervous system disorders
Formication
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Nervous system disorders
Hypogeusia
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Nervous system disorders
Sedation
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.7%
3/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Infections and infestations
Gastroenteritis
|
5.7%
3/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Infections and infestations
Urinary Tract Infection
|
5.7%
3/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Infections and infestations
Influenza
|
0.00%
0/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Infections and infestations
Dermatitis Infected
|
0.00%
0/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Infections and infestations
Skin Infection
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Gastrointestinal disorders
Nausea
|
9.4%
5/53 • Up to week 10
|
5.9%
3/51 • Up to week 10
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.8%
2/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.9%
1/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Gastrointestinal disorders
Food Poisoning
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Psychiatric disorders
Anxiety
|
5.7%
3/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Psychiatric disorders
Irritability
|
5.7%
3/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Psychiatric disorders
Restlessness
|
3.8%
2/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Psychiatric disorders
Suicidal Ideation
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/53 • Up to week 10
|
3.9%
2/51 • Up to week 10
|
|
Investigations
Amylase Increased
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Investigations
Lipase Increased
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Investigations
Weight Increased
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
General disorders
Non-Cardiac Chest Pain
|
1.9%
1/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
General disorders
Fatigue
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
General disorders
Influenza Like Illness
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Eye disorders
Vision Blurred
|
3.8%
2/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Blood and lymphatic system disorders
Benign Ethnic Neutropenia
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/53 • Up to week 10
|
2.0%
1/51 • Up to week 10
|
|
Vascular disorders
Hot Flush
|
1.9%
1/53 • Up to week 10
|
0.00%
0/51 • Up to week 10
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Additional Information
Jane Tiller, MD; Study Director
BlackThorn Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place