BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder

• Sponsor: BlackThorn Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03193398
• Collaborator: (none)
• Enrollment: 104
• Locations: 8
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site: 13
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: BTRX-246040 oral capsule(s); Drug: Placebo oral capsule(s)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Study Of BTRX-246040 Administered Once Daily In Patients With Major Depressive Disorder With Or Without Anhedonia
• Actual Study Start Date: Jun 12, 2017
• Actual Primary Completion Date: Nov 12, 2018
• Actual Study Completion Date: Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BTRX-246040 40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.	Drug: BTRX-246040 oral capsule(s); BTRX-246040 administered once daily to patients with MDD for 8 weeks
Placebo Comparator: Placebo administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.	Drug: Placebo oral capsule(s); administered once daily to patients with MDD for 8 weeks

Outcome Measures

Primary Outcome Measures

1. Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo [Week 8]

   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.

Secondary Outcome Measures

1. Change From Baseline in Investigator-administered MADRS-6 Total Score [Week 8]

   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.

2. Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score [Week 8]

   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.

3. Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score [Week 8]

   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.

4. Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) [Week 8]

   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.

5. Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score [Week 8]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1 prior major depressive episode in the past 10 years

• Patients must present with a new current episode of MDD and the duration of the current episode must be at least 4 weeks but not longer than 18 months.

• At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically significant depressive symptoms defined by tandem (investigator- and computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores ≥ 26 with a difference of ≤ 7 points between the Investigator- and computer-administered MADRS total scores

• Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).

Exclusion Criteria:

• Patients who present with any current DSM-5 disorder other than MDD which is the focus of treatment.

• Patients who are homicidal in the opinion of the Investigator or are at suicidal risk (any suicide attempts within 12 months prior to Visit 1 [screening] or any suicidal intent, including a plan, within 3 months prior to Visit 1 [screening]; C-SSRS answer of "YES" on item 4 or 5 [suicidal ideation]; Investigator- or computer-administered MADRS score of ≥ 5 on item 10 [suicidal thoughts]; by Investigator clinical evaluation).

• Patients cannot have any history of substance or alcohol use disorder within 12 months prior to Visit 1 (screening) per DSM-5 criteria

• Patients must not have a clinically significant comorbid disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United States	Cerritos	California	United States	90703
2	United States	Garden Grove	California	United States	92845
3	United States, Florida	Jacksonville	Florida	United States	32256
4	United States	Lauderhill	Florida	United States	33319
5	United States, Florida	Orlando	Florida	United States	32801
6	United States	Libertyville	Illinois	United States	60048
7	United States	Rochester	New York	United States	14618
8	United States	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• BlackThorn Therapeutics, Inc.

Investigators

• Study Director: Jane Tiller, MD, BlackThorn Therapeutics, Inc.

Study Documents (Full-Text)

• Study Protocol - Nov 20, 2018
• Statistical Analysis Plan - Dec 6, 2018

More Information

Publications

None provided.

• Responsible Party: BlackThorn Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03193398
• Other Study ID Numbers: NEP-MDD-201
• First Posted: Jun 20, 2017
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by BlackThorn Therapeutics, Inc.: Major Depressive Disorder; Anhedonia; antidepressant; Nociceptin; NOPR
• Additional relevant MeSH terms: Disease; Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

Participant Flow

Recruitment Details	Total of 104 subjects were randomized for the study NEP-MDD-201

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	53	51
COMPLETED	38	35
NOT COMPLETED	15	16

Baseline Characteristics

Arm/Group Title	BTRX-246040	Placebo	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	52	50	102
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.3 (12.29)	42.6 (15.00)	40.9 (13.72)
Sex: Female, Male (Count of Participants)
Female	11 21.2%	13 26%	24 23.5%
Male	41 78.8%	37 74%	78 76.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 17.3%	9 18%	18 17.6%
Not Hispanic or Latino	43 82.7%	41 82%	84 82.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 1.9%	3 6%	4 3.9%
Black or African American	22 42.3%	19 38%	41 40.2%
Native Hawaiian or Other Pacific Islanders	0 0%	1 2%	1 1%
White	24 46.2%	26 52%	50 49%
Multiracial	5 9.6%	1 2%	6 5.9%

Outcome Measures

1. Primary Outcome

Title	Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	-15.0 (1.73)	-13.6 (1.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BTRX-246040, Placebo
	Comments	Difference in LS Means (BTRX-246040 - Placebo)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5939
	Comments
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -6.3 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Investigator-administered MADRS-6 Total Score
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	-10.7 (1.17)	-9.7 (1.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5503
	Comments
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -4.4 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	-2.6 (0.67)	-3.5 (0.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BTRX-246040, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3906
	Comments
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.1 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	-5.0 (0.76)	-5.9 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BTRX-246040, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4187
	Comments	+/-
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -1.3 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	13.7 (16.7)	2.91 (3.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BTRX-246040, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4869
	Comments
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -11.5 to 5.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BTRX-246040	Placebo
Arm/Group Description	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	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
Measure Participants	52	50
Least Squares Mean (Standard Error) [Change in score on a scale from baseline]	-6.7 (1.24)	-7.9 (1.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BTRX-246040
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5178
	Comments
	Method	MMRM
	Comments	MMRM: mixed model for repeated measures
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -2.4 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Up to week 10
Arm/Group Title	BTRX-246040		Placebo
Arm/Group Description	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		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
All Cause Mortality
	BTRX-246040		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/51 (0%)
Serious Adverse Events
	BTRX-246040		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		1/51 (2%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	0/53 (0%)		1/51 (2%)
Other (Not Including Serious) Adverse Events
	BTRX-246040		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/53 (64.2%)		27/51 (52.9%)
Blood and lymphatic system disorders
Benign Ethnic Neutropenia	1/53 (1.9%)		0/51 (0%)
Cardiac disorders
Tachycardia	1/53 (1.9%)		0/51 (0%)
Ear and labyrinth disorders
Ear Discomfort	0/53 (0%)		1/51 (2%)
Eye disorders
Vision Blurred	2/53 (3.8%)		0/51 (0%)
Eyelid Oedema	0/53 (0%)		1/51 (2%)
Lacrimation Increased	0/53 (0%)		1/51 (2%)
Gastrointestinal disorders
Nausea	5/53 (9.4%)		3/51 (5.9%)
Diarrhoea	2/53 (3.8%)		1/51 (2%)
Abdominal Pain	2/53 (3.8%)		1/51 (2%)
Abdominal Pain Upper	1/53 (1.9%)		1/51 (2%)
Constipation	0/53 (0%)		1/51 (2%)
Dyspepsia	1/53 (1.9%)		0/51 (0%)
Food Poisoning	1/53 (1.9%)		0/51 (0%)
Toothache	1/53 (1.9%)		0/51 (0%)
Vomiting	1/53 (1.9%)		0/51 (0%)
General disorders
Non-Cardiac Chest Pain	1/53 (1.9%)		1/51 (2%)
Fatigue	1/53 (1.9%)		0/51 (0%)
Influenza Like Illness	0/53 (0%)		1/51 (2%)
Infections and infestations
Upper Respiratory Tract Infection	3/53 (5.7%)		2/51 (3.9%)
Gastroenteritis	3/53 (5.7%)		1/51 (2%)
Urinary Tract Infection	3/53 (5.7%)		1/51 (2%)
Influenza	0/53 (0%)		2/51 (3.9%)
Dermatitis Infected	0/53 (0%)		2/51 (3.9%)
Pharyngitis	1/53 (1.9%)		0/51 (0%)
Skin Infection	1/53 (1.9%)		0/51 (0%)
Tooth Infection	0/53 (0%)		1/51 (2%)
Viral Upper Respiratory Tract Infection	1/53 (1.9%)		0/51 (0%)
Vulvovaginal Mycotic Infection	0/53 (0%)		1/51 (2%)
Injury, poisoning and procedural complications
Contusion	0/53 (0%)		1/51 (2%)
Laceration	0/53 (0%)		1/51 (2%)
Ligament Rupture	0/53 (0%)		1/51 (2%)
Muscle Strain	0/53 (0%)		1/51 (2%)
Procedural Pain	0/53 (0%)		1/51 (2%)
Road Traffic Accident	0/53 (0%)		1/51 (2%)
Skin Abrasion	0/53 (0%)		1/51 (2%)
Investigations
Alanine Aminotransferase Increased	0/53 (0%)		2/51 (3.9%)
Aspartate Aminotransferase Increased	0/53 (0%)		2/51 (3.9%)
Blood Creatine Phosphokinase Increased	0/53 (0%)		2/51 (3.9%)
Amylase Increased	0/53 (0%)		1/51 (2%)
Lipase Increased	0/53 (0%)		1/51 (2%)
Weight Increased	1/53 (1.9%)		0/51 (0%)
Metabolism and nutrition disorders
Decreased Appetite	0/53 (0%)		1/51 (2%)
Musculoskeletal and connective tissue disorders
Myalgia	1/53 (1.9%)		2/51 (3.9%)
Back Pain	0/53 (0%)		1/51 (2%)
Intervertebral Disc Protrusion	1/53 (1.9%)		0/51 (0%)
Muscle Spasms	1/53 (1.9%)		0/51 (0%)
Muscle Tightness	1/53 (1.9%)		0/51 (0%)
Muscle Twitching	1/53 (1.9%)		0/51 (0%)
Neck Pain	1/53 (1.9%)		0/51 (0%)
Pain In Extremity	0/53 (0%)		1/51 (2%)
Nervous system disorders
Headache	8/53 (15.1%)		13/51 (25.5%)
Somnolence	3/53 (5.7%)		7/51 (13.7%)
Dizziness	1/53 (1.9%)		2/51 (3.9%)
Paraesthesia	2/53 (3.8%)		0/51 (0%)
Disturbance In Attention	0/53 (0%)		1/51 (2%)
Formication	0/53 (0%)		1/51 (2%)
Hypogeusia	1/53 (1.9%)		0/51 (0%)
Sedation	0/53 (0%)		1/51 (2%)
Psychiatric disorders
Anxiety	3/53 (5.7%)		1/51 (2%)
Irritability	3/53 (5.7%)		1/51 (2%)
Insomnia	1/53 (1.9%)		1/51 (2%)
Restlessness	2/53 (3.8%)		0/51 (0%)
Abnormal Dreams	0/53 (0%)		1/51 (2%)
Suicidal Ideation	1/53 (1.9%)		0/51 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/53 (1.9%)		0/51 (0%)
Oropharyngeal Pain	0/53 (0%)		1/51 (2%)
Throat Irritation	1/53 (1.9%)		0/51 (0%)
Skin and subcutaneous tissue disorders
Acne	1/53 (1.9%)		0/51 (0%)
Pruritus Generalised	1/53 (1.9%)		0/51 (0%)
Vascular disorders
Hot Flush	1/53 (1.9%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.