Trial Outcomes & Findings for The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD) (NCT NCT04279522)
NCT ID: NCT04279522
Last Updated: 2025-08-12
Results Overview
Mean change in depressive symptoms, measured by HDRS17 total score, from baseline to week-8 post treatment initiation. The HDRS-17 (17-item Hamilton Depression Rating Scale) is a widely used, clinician-administered questionnaire designed to assess the severity of depressive symptoms. Total score ranges from 0 to 52-higher scores indicate more severe depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
8 weeks from treatment initiation
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Group 1 - Active Stimulation
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Period 1: Double Blind Phase
STARTED
|
62
|
62
|
|
Period 1: Double Blind Phase
COMPLETED
|
51
|
53
|
|
Period 1: Double Blind Phase
NOT COMPLETED
|
11
|
9
|
|
Period 2: Open Label Phase
STARTED
|
46
|
50
|
|
Period 2: Open Label Phase
COMPLETED
|
42
|
43
|
|
Period 2: Open Label Phase
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Group 1 - Active Stimulation
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Period 1: Double Blind Phase
Lost to Follow-up
|
0
|
1
|
|
Period 1: Double Blind Phase
Withdrawal by Subject
|
10
|
8
|
|
Period 1: Double Blind Phase
Protocol Violation
|
1
|
0
|
|
Period 2: Open Label Phase
Lost to Follow-up
|
1
|
1
|
|
Period 2: Open Label Phase
Withdrawal by Subject
|
2
|
2
|
|
Period 2: Open Label Phase
Physician Decision
|
0
|
3
|
|
Period 2: Open Label Phase
Adverse Event
|
0
|
1
|
|
Period 2: Open Label Phase
Protocol Violation
|
1
|
0
|
Baseline Characteristics
The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Group 1 - Active Stimulation
n=62 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=62 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 Years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
48.1 Years
STANDARD_DEVIATION 13.14 • n=7 Participants
|
48.6 Years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African or African-American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of antidepressant medications with none or insufficient response in the current episode
|
1.8 Number of antidepressant medications
STANDARD_DEVIATION 0.97 • n=5 Participants
|
1.8 Number of antidepressant medications
STANDARD_DEVIATION 0.89 • n=7 Participants
|
1.8 Number of antidepressant medications
STANDARD_DEVIATION 0.93 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Mean change in depressive symptoms, measured by HDRS17 total score, from baseline to week-8 post treatment initiation. The HDRS-17 (17-item Hamilton Depression Rating Scale) is a widely used, clinician-administered questionnaire designed to assess the severity of depressive symptoms. Total score ranges from 0 to 52-higher scores indicate more severe depression.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Mean Change in Depressive Symptoms, Measured by HDRS17 Total Score
|
-8.62 units on a scale
Standard Error 0.8476
|
-6.01 units on a scale
Standard Error 0.8257
|
SECONDARY outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Proportion of responder subjects- defined as the percent of subjects achieving at least 50% reduction from baseline in their HDRS17 scale 8 weeks post Relivion®DP treatment initiation.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Percentage of Responder Participants
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Proportion of subjects achieving remission- defined as the percent of subjects with HDRS17 score≤7 at 8 weeks post treatment initiation
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Percentage of Subjects Achieving Remission
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Mean change in depressive symptoms, measured by MADRS total score, from baseline to week-8 post treatment initiation. The MADRS stands for the Montgomery-Åsberg Depression Rating Scale. It is a clinician-administered tool used to assess the severity of depressive symptoms, particularly in clinical trials and psychiatric evaluations. Contains 10 items, each scored from 0 to 6, with a total possible score ranging from 0 to 60. Higher scores indicate more severe depression.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Mean Change in Depressive Symptoms, Measured by MADRS Total Score
|
-10.18 units on a scale
Standard Error 1.2874
|
-8.09 units on a scale
Standard Error 1.2611
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Mean Change in the severity and improvement scores - Clinical Global Impression scales (CGI-S and CGI-I) at 8 weeks post treatment initiation. he CGI-S (Clinical Global Impression - Severity) and CGI-I (Clinical Global Impression - Improvement) are two components of the CGI scale, a brief, standardized assessment used by clinicians to rate the severity of a patient's illness and their improvement over time, typically in clinical trials and psychiatric practice. both on a Scale of 1 to 7. higher score on the CGI-S indicate more severe depression. Higher score on the CGI-I indicates worsening depression.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Mean Change in Depressive Symptoms Severity and Improvement Scores
CGI-S
|
-1.15 units on a scale
Standard Error 0.1703
|
-0.85 units on a scale
Standard Error 0.1661
|
|
Mean Change in Depressive Symptoms Severity and Improvement Scores
CGI-I
|
3.51 units on a scale
Standard Error 0.2021
|
4.05 units on a scale
Standard Error 0.1975
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Mean Change from baseline in total score of the Quick Inventory of Depressive Symptomatology self-rated (QIDS-SR-16) score at 8 weeks post treatment initiation. The QIDS-SR-16 stands for the Quick Inventory of Depressive Symptomatology - Self-Report, 16-item version. It is a self-administered questionnaire designed to assess the severity of depressive symptoms in patients. Total score range: 0 to 27. Higher scores indicate more severe depression.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Mean Change in Quick Inventory of Depressive Symptomatology Self-rated Score
|
-4.59 units on a scale
Standard Error 0.6407
|
-3.57 units on a scale
Standard Error 0.6294
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks from treatment initiationPopulation: mITT
Mean change in depressive symptoms, measured by HDRS21 total score, from baseline to week-8 post Relivion®DP treatment initiation. The HDRS-21, or 21-item Hamilton Depression Rating Scale, is an extended version of the original Hamilton Depression Rating Scale (HDRS17). It is a clinician-administered tool designed to assess the severity of depressive symptoms in patients diagnosed with major depressive disorder (MDD). Total score range: 0 to 64. higher scores indicate more severe depression.
Outcome measures
| Measure |
Group 1 - Active Stimulation
n=47 Participants
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=50 Participants
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
|---|---|---|
|
Mean Change in Depressive Symptoms, Measured by HDRS21 Total Score
|
-8.86 units on a scale
Standard Error 0.8916
|
-6.11 units on a scale
Standard Error 0.8658
|
Adverse Events
Group 1 - Active Stimulation
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 2 - Sham Stimulation
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Open Label Active Stimulation
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Active Stimulation
n=62 participants at risk
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=62 participants at risk
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
Open Label Active Stimulation
n=96 participants at risk
Relivion®DP- Active stimulation device
|
|---|---|---|---|
|
Psychiatric disorders
worsening of depression symptoms
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.0%
1/96 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
Other adverse events
| Measure |
Group 1 - Active Stimulation
n=62 participants at risk
Relivion®DP- Active: Relivion®DP- Active stimulation device
|
Group 2 - Sham Stimulation
n=62 participants at risk
Relivion®DP- Sham: Relivion®DP- Sham stimulation device
|
Open Label Active Stimulation
n=96 participants at risk
Relivion®DP- Active stimulation device
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
8.1%
5/62 • Number of events 19 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
3.2%
2/62 • Number of events 2 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
5.2%
5/96 • Number of events 12 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Skin and subcutaneous tissue disorders
Redness/ indentation on forehead
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/96 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Skin and subcutaneous tissue disorders
Scalp itching
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/96 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Skin and subcutaneous tissue disorders
Skin irritation/ erythema
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.0%
1/96 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Skin and subcutaneous tissue disorders
Stinging sensation
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/96 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Nervous system disorders
Migraine
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/96 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Psychiatric disorders
Worsening depression symptoms
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.0%
1/96 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Ear and labyrinth disorders
Pressure in ears
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
1.6%
1/62 • Number of events 1 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/96 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
General disorders
AEs definitely not related to the study device
|
21.0%
13/62 • Number of events 19 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
25.8%
16/62 • Number of events 21 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
22.9%
22/96 • Number of events 26 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
|
Skin and subcutaneous tissue disorders
Unpleasant sensation during treatment
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
0.00%
0/62 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
2.1%
2/96 • Number of events 3 • throughout the study conduct from the point of enrollment, for each enrolled subject up to 18 weeks post treatment initiation. per protocol each of the treatment periods (Double Blind and Open Label) lasted up to 9 weeks.
Safety of the study device following study treatment: incidence of adverse events and serious adverse events related or unrelated to the study device.
|
Additional Information
Yaron Gruper, Director of Clinical affairs
Neurolief Ltd.
Phone: +972-544330712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall have the right to publish the results and information about the results. PI agree to submit any proposed publication to Sponsor for review and approval at least 60 days prior to submitting to a publisher. Sponsor shall respond in writing within 45 days of its receipt and have the right to require PI to (a) remove Confidential Information; (b) delay the proposed Publication for an additional ninety (90) days to enable Sponsor to seek patent application or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER