Trial Outcomes & Findings for Botulinum Toxin for the Management of Chronic Orchialgia (NCT NCT02058836)

NCT ID: NCT02058836

Last Updated: 2018-09-05

Results Overview

Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and 1 Week Post Injection
• Results posted on: 2018-09-05

Participant Flow

Participant milestones

Measure	Botox Injection The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Overall Study STARTED	4	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Botox Injection The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Botulinum Toxin for the Management of Chronic Orchialgia

Baseline characteristics by cohort

Measure	Botox Injection n=4 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=4 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Total n=8 Participants Total of all reporting groups
Age, Continuous	75.25 years STANDARD_DEVIATION 8.14 • n=5 Participants	56.25 years STANDARD_DEVIATION 12.5 • n=7 Participants	65.75 years STANDARD_DEVIATION 14.10 • n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 Week Post Injection

Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Visual Analog Scale for Pain Score Baseline	59.3 units on a scale Standard Deviation 17.6	30.3 units on a scale Standard Deviation 16.4
Visual Analog Scale for Pain Score 1 Week Post Procedure	55.0 units on a scale Standard Deviation 22.9	75.0 units on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: 1 month

Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Visual Analog Scale for Pain Score Baseline	59.3 units on a scale Standard Deviation 17.6	30.3 units on a scale Standard Deviation 16.4
Visual Analog Scale for Pain Score 1 Month Post Procedure	56 units on a scale Standard Deviation 31.5	72.7 units on a scale Standard Deviation 30.0

PRIMARY outcome

Timeframe: 3 months

Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Visual Analog Scale for Pain Score Baseline	59.3 units on a scale Standard Deviation 17.6	30.3 units on a scale Standard Deviation 16.4
Visual Analog Scale for Pain Score 3 Months Post Procedure	63 units on a scale Standard Deviation 20.6	84 units on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: 6 months

Visual Analog Scale for Pain score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Visual Analog Scale for Pain Score Baseline	59.3 units on a scale Standard Deviation 17.6	30.3 units on a scale Standard Deviation 16.4
Visual Analog Scale for Pain Score 6 Months Post Procedure	78.7 units on a scale Standard Deviation 12.1	61 units on a scale Standard Deviation 29.5

PRIMARY outcome

Timeframe: 1 week

Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=2 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Quality of Life Questionnaire Score	67.41 units on a scale Standard Deviation 18.27	84.31 units on a scale Standard Deviation 6.48

PRIMARY outcome

Timeframe: 1 month

Quality of Life Questionnaire Score. To assess the QOL, a SF-36 was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The score range is 0-100 and higher scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Quality of Life Questionnaire Score	66.48 units on a scale Standard Deviation 33.40	83.66 units on a scale Standard Deviation 14.94

PRIMARY outcome

Timeframe: 3 months

Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Quality of Life Questionnaire Score	67.56 units on a scale Standard Deviation 30.90	84.44 units on a scale Standard Deviation 11.46

PRIMARY outcome

Timeframe: 6 months

Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Quality of Life Questionnaire Score	77.04 units on a scale Standard Deviation 14.29	86.59 units on a scale Standard Deviation 9.23

PRIMARY outcome

Timeframe: 1 week

Change from Baseline in Units of Analgesics Used for Testicular Pain

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Units of Analgesics Used for Testicular Pain Baseline	3.3 units of analgesics Standard Deviation 5.77	2.5 units of analgesics Standard Deviation 2.5
Units of Analgesics Used for Testicular Pain 1 Week Post Procedure	1.7 units of analgesics Standard Deviation 2.9	2.1 units of analgesics Standard Deviation 2.6

PRIMARY outcome

Timeframe: 1 month

Change from Baseline in Units of Analgesics Used for Testicular Pain

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Units of Analgesics Used for Testicular Pain Baseline	3.3 units of analgesics Standard Deviation 5.77	2.5 units of analgesics Standard Deviation 2.5
Units of Analgesics Used for Testicular Pain 1 Month Post Procedure	.13 units of analgesics Standard Deviation .23	2.1 units of analgesics Standard Deviation 2.6

PRIMARY outcome

Timeframe: 3 months

Change from Baseline in Units of Analgesics Used for Testicular Pain

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Units of Analgesics Used for Testicular Pain Baseline	3.3 units of analgesics Standard Deviation 5.77	2.5 units of analgesics Standard Deviation 2.5
Units of Analgesics Used for Testicular Pain 3 Months Post Procedure	.67 units of analgesics Standard Deviation 1.2	2 units of analgesics Standard Deviation 2.6

PRIMARY outcome

Timeframe: 6 months

Change from Baseline in Units of Analgesics Used for Testicular Pain

Outcome measures

Measure	Botox Injection n=3 Participants The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.	Saline Injection n=3 Participants The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment. Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Units of Analgesics Used for Testicular Pain Baseline	3.3 units of analgesics Standard Deviation 5.77	2.5 units of analgesics Standard Deviation 2.5
Units of Analgesics Used for Testicular Pain 6 Months Post Procedure	0 units of analgesics Standard Deviation 0	2.5 units of analgesics Standard Deviation 2.5

Adverse Events

Botox Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ryan Terlecki

Wake Forest University Health Sciences

Phone: 336-716-2011

Email: rterlecki@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place