Trial Outcomes & Findings for OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females (NCT NCT02116361)
NCT ID: NCT02116361
Last Updated: 2017-12-19
Results Overview
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
258 participants
Primary outcome timeframe
Baseline
Results posted on
2017-12-19
Participant Flow
Participant milestones
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
65
|
59
|
65
|
|
Overall Study
COMPLETED
|
38
|
34
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
31
|
31
|
26
|
31
|
Reasons for withdrawal
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
3
|
|
Overall Study
Other Reasons
|
3
|
3
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
7
|
5
|
|
Overall Study
Personal Reasons
|
6
|
6
|
4
|
9
|
|
Overall Study
Investigator Decision - Relapse
|
9
|
7
|
8
|
5
|
Baseline Characteristics
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Baseline characteristics by cohort
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<40 years
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Age, Customized
≥ 40 years
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
31.4 Scores on a Scale
Standard Deviation 3.99
|
32.0 Scores on a Scale
Standard Deviation 4.12
|
32.4 Scores on a Scale
Standard Deviation 5.34
|
32.0 Scores on a Scale
Standard Deviation 4.44
|
PRIMARY outcome
Timeframe: Week 6Population: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-7.9 Scores on a Scale
Standard Error 1.4
|
-11.6 Scores on a Scale
Standard Error 1.4
|
-12.9 Scores on a Scale
Standard Error 1.2
|
-11.5 Scores on a Scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
|
4.2 Scores on a Scale
Standard Deviation 0.43
|
4.4 Scores on a Scale
Standard Deviation 0.53
|
4.4 Scores on a Scale
Standard Deviation 0.53
|
4.5 Scores on a Scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=33 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=36 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=38 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=34 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
|
-1.4 Scores on a Scale
Standard Error 0.2
|
-1.9 Scores on a Scale
Standard Error 0.2
|
-2.6 Scores on a Scale
Standard Error 0.2
|
-2.9 Scores on a Scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
|
23.7 Scores on a Scale
Standard Deviation 3.15
|
24.5 Scores on a Scale
Standard Deviation 3.03
|
23.3 Scores on a Scale
Standard Deviation 2.94
|
23.0 Scores on a Scale
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=33 Participants
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=36 Participants
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=38 Participants
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=34 Participants
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
|
-11.5 Scores on a Scale
Standard Error 1.1
|
-13.4 Scores on a Scale
Standard Error 1.1
|
-16.1 Scores on a Scale
Standard Error 0.8
|
-17.4 Scores on a Scale
Standard Error 0.8
|
Adverse Events
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
onabotulinumtoxinA 50 U
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
onabotulinumtoxinA 30 U
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 participants at risk
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 participants at risk
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 participants at risk
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 participants at risk
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm
|
0.00%
0/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
1.7%
1/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
1.5%
1/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Psychiatric disorders
Hallucination, Auditory
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Psychiatric disorders
Suicidal Ideation
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
1.5%
1/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Vascular disorders
Varicose Vein
|
1.5%
1/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
General disorders
Sudden Death
|
0.00%
0/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
1.5%
1/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
Other adverse events
| Measure |
Placebo (Normal Saline) for onabotulinumtoxinA 50 U
n=67 participants at risk
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 50 U
n=65 participants at risk
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
|
Placebo (Normal Saline) for onabotulinumtoxinA 30 U
n=58 participants at risk
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
onabotulinumtoxinA 30 U
n=65 participants at risk
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
6.9%
4/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
6.2%
4/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Infections and infestations
URI
|
4.5%
3/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
6.2%
4/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
1.7%
1/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
4.6%
3/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Nervous system disorders
Headache
|
22.4%
15/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
16.9%
11/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
6.9%
4/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
13.8%
9/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
3.1%
2/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
0.00%
0/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
6.2%
4/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
6/67
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
4.6%
3/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
5.2%
3/58
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
3.1%
2/65
The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER