Trial Outcomes & Findings for Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder (NCT NCT01370733)

Last Updated: 2015-10-26

Results Overview

The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

202 participants

Primary outcome timeframe

Baseline to End of Double-Blind Treatment Period (Week 6)

Results posted on

2015-10-26

Participant Flow

Enrollment occurred across 17 study sites (both academic and private clinical locations), initiated in May 2012 and all subject visits complete by July 2013. Three sites discontinued early due to departure of the Principal Investigator or due to a loss of contributing staff personnel. None were discontinued specifically due to a lack of enrollment.

Upon study closure, 291 subjects were consented for possible study participation with 202 of those subjects subsequently enrolled and randomized to treatment. Those entering the study at Screening while currently on an antidepressant required a minimum 1-week wash out period prior to completing a Baseline (Day 0) visit.

Participant milestones

Participant milestones
Measure	Active sTMS Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Overall Study STARTED	103	99
Overall Study COMPLETED	86	77
Overall Study NOT COMPLETED	17	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Active sTMS Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Overall Study Withdrawal by Subject	8	8
Overall Study Lost to Follow-up	3	0
Overall Study Adverse Event	2	4
Overall Study Lack of Efficacy	3	5
Overall Study Physician Decision	0	2
Overall Study Protocol Violation	1	3

Baseline Characteristics

Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active sTMS n=103 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.	Total n=202 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 11.3 • n=5 Participants	45.7 years STANDARD_DEVIATION 12.2 • n=7 Participants	45.9 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	66 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	33 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized American Indian / Alaskan Native	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	82 participants n=5 Participants	79 participants n=7 Participants	161 participants n=5 Participants
Race/Ethnicity, Customized Other or Unknown	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants	99 participants n=7 Participants	202 participants n=5 Participants
Baseline Mean Hamilton Rating Scale for Depression (HAM-D17)	21.94 units on a scale STANDARD_DEVIATION 3.46 • n=5 Participants	21.15 units on a scale STANDARD_DEVIATION 3.25 • n=7 Participants	21.55 units on a scale STANDARD_DEVIATION 3.37 • n=5 Participants
Length of Current Episode in Months	10.9 months STANDARD_DEVIATION 6.8 • n=5 Participants	10.8 months STANDARD_DEVIATION 6.7 • n=7 Participants	10.85 months STANDARD_DEVIATION 6.73 • n=5 Participants
Antidepressant Exposure in Current Episode Inadequate Dose/Duration of >= 1 Medication	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Antidepressant Exposure in Current Episode Intolerant of >= 1 Medication	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants
Antidepressant Exposure in Current Episode Treatment Naive (ATHF 0)	40 participants n=5 Participants	37 participants n=7 Participants	77 participants n=5 Participants
Antidepressant Exposure in Current Episode Adequate Trial of >= 1 Medication	61 participants n=5 Participants	65 participants n=7 Participants	126 participants n=5 Participants
Education Level Some high school or less	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Education Level High school diploma	19 participants n=5 Participants	7 participants n=7 Participants	26 participants n=5 Participants
Education Level Vocational school	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Education Level Some college	17 participants n=5 Participants	31 participants n=7 Participants	48 participants n=5 Participants
Education Level College degree	42 participants n=5 Participants	42 participants n=7 Participants	84 participants n=5 Participants
Education Level Professional or Graduate degree	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants
Education Level Unknown	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.

Outcome measures

Outcome measures
Measure	Active sTMS n=103 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Mean HAM-D17 Total Score Change (Intent to Treat - All)	-7.49 units on a scale Standard Deviation 7.25	-6.97 units on a scale Standard Deviation 6.28

PRIMARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Per Protocol Population

The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

Outcome measures

Outcome measures
Measure	Active sTMS n=59 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=61 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Mean HAM-D17 Total Score Change (Per Protocol - All)	-9.00 units on a scale Standard Deviation 6.54	-6.56 units on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Per Protocol Population - Non-Naive Subjects

All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change. This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

Outcome measures

Outcome measures
Measure	Active sTMS n=38 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=36 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)	-8.58 units on a scale Standard Deviation 6.93	-4.25 units on a scale Standard Deviation 4.75

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=103 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)	27 participants	25 participants

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Per Protocol Population

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=59 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=61 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)	20 participants	18 participants

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Per Protocol Population - Non-Naive Subjects

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=38 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=36 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)	13 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used. This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=103 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)	11 participants	14 participants

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (up to week 6)

Population: Per Protocol Population

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=59 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=61 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)	9 participants	10 participants

SECONDARY outcome

Timeframe: Baseline to End of Double-Blind Treatment Period (Week 6)

Population: Per Protocol Population - Non-Naive Subjects

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive). This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population. The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Outcome measures

Outcome measures
Measure	Active sTMS n=38 Participants Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=36 Participants Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)	5 participants	2 participants

Adverse Events

Active sTMS

Serious events: 2 serious events

Other events: 80 other events

Deaths: 0 deaths

Sham

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active sTMS n=103 participants at risk Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 participants at risk Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Psychiatric disorders Hospitalization (Suicide Attempt)	0.00% 0/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	1.0% 1/99 • Number of events 1 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Psychiatric disorders Hospitalization (Risk of Self Harm)	0.97% 1/103 • Number of events 1 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Gastrointestinal disorders Hospitalization (Dehydration)	0.97% 1/103 • Number of events 1 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.

Other adverse events

Other adverse events
Measure	Active sTMS n=103 participants at risk Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.	Sham n=99 participants at risk Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Ear and labyrinth disorders Tinnitus	2.9% 3/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	1.0% 1/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Eye disorders Visual Disturbance	2.9% 3/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Gastrointestinal disorders Dyschezia	2.9% 3/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	2.0% 2/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Gastrointestinal disorders Non-Specific GI Discomfort	3.9% 4/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	3.0% 3/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Musculoskeletal and connective tissue disorders Back Pain	8.7% 9/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	4.0% 4/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Musculoskeletal and connective tissue disorders Hand/Arm/Shoulder Pain	2.9% 3/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Musculoskeletal and connective tissue disorders Leg and Foot Pain	3.9% 4/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Nervous system disorders Agitation	3.9% 4/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	1.0% 1/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Nervous system disorders Dizziness	3.9% 4/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	2.0% 2/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Nervous system disorders Headache	21.4% 22/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	19.2% 19/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Nervous system disorders Paresthesia	3.9% 4/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Psychiatric disorders Insomnia	6.8% 7/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	5.1% 5/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Psychiatric disorders Lack of Energy	2.9% 3/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	0.00% 0/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.
Respiratory, thoracic and mediastinal disorders Respiratory Infection	6.8% 7/103 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.	5.1% 5/99 • All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination. Primarily systematic assessments, some reporting was unsolicited although minimal.

Additional Information

Dr. Andrew Leuchter, MD

University of California Los Angeles

Phone: (310) 825-0207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place