Trial Outcomes & Findings for Study of Antibody for Methamphetamine Outpatient Therapy (NCT NCT03336866)
NCT ID: NCT03336866
Last Updated: 2022-03-10
Results Overview
METH AUCinf following IXT-m200 dosing on each METH Challenge Day.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Day 1, 5, 12, 19, and 26
Results posted on
2022-03-10
Participant Flow
Participants were recruited at two clinical research sites in Salt Lake City, UT and Anaheim, CA between April 2018 and October 2020.
Participants underwent drug discrimination testing on Day 1 (30 mg IV methamphetamine vs normal saline). Those who reported appropriate responses on drug effects questionnaires and had no safety concerns following IV methamphetamine dosing were allowed to continue in the study. 77 subjects were enrolled, 10 discontinued or withdrew after Day 1 and 11 did not pass drug discrimination and were disqualified.
Participant milestones
| Measure |
Placebo
Normal saline
Placebo: Normal saline
|
IXT-m200, 6 mg/kg
Single 6 mg/kg intravenous dose of IXT-m200
IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody
|
IXT-m200, 20 mg/kg
Single IV dose of 20 mg/kg IXT-m200
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Normal saline
Placebo: Normal saline
|
IXT-m200, 6 mg/kg
Single 6 mg/kg intravenous dose of IXT-m200
IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody
|
IXT-m200, 20 mg/kg
Single IV dose of 20 mg/kg IXT-m200
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Noncompliance with clinic house rules
|
0
|
0
|
1
|
Baseline Characteristics
Study of Antibody for Methamphetamine Outpatient Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Normal saline
Placebo: Normal saline
|
IXT-m200, 6 mg/kg
n=18 Participants
Single 6 mg/kg intravenous dose of IXT-m200
IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 7.79 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 7.40 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 7.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Weight
|
76.12 kg
STANDARD_DEVIATION 13.109 • n=5 Participants
|
75.15 kg
STANDARD_DEVIATION 13.832 • n=7 Participants
|
79.59 kg
STANDARD_DEVIATION 12.624 • n=5 Participants
|
76.92 kg
STANDARD_DEVIATION 13.090 • n=4 Participants
|
|
Height
|
172.23 cm
STANDARD_DEVIATION 10.827 • n=5 Participants
|
171.32 cm
STANDARD_DEVIATION 8.852 • n=7 Participants
|
177.34 cm
STANDARD_DEVIATION 7.093 • n=5 Participants
|
173.58 cm
STANDARD_DEVIATION 9.340 • n=4 Participants
|
|
BMI
|
25.71 kg/m^2
STANDARD_DEVIATION 3.953 • n=5 Participants
|
25.56 kg/m^2
STANDARD_DEVIATION 4.088 • n=7 Participants
|
25.36 kg/m^2
STANDARD_DEVIATION 4.056 • n=5 Participants
|
25.55 kg/m^2
STANDARD_DEVIATION 3.959 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: This outcome used the pharmacokinetic (PK) set. The PK set consisted of all subjects in the safety analysis set for whom at least 1 PK parameter could be calculated for METH or IXT-m200.
METH AUCinf following IXT-m200 dosing on each METH Challenge Day.
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=18 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 1, AUCinf
|
1635 h*ng/mL
Standard Deviation 1345
|
1433 h*ng/mL
Standard Deviation 555
|
1265 h*ng/mL
Standard Deviation 350
|
|
Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 5, AUCinf
|
1233 h*ng/mL
Standard Deviation 323
|
14042 h*ng/mL
Standard Deviation 3067
|
39379 h*ng/mL
Standard Deviation 8288
|
|
Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 12, AUCinf
|
1254 h*ng/mL
Standard Deviation 341
|
8210 h*ng/mL
Standard Deviation 2184
|
21846 h*ng/mL
Standard Deviation 3915
|
|
Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 19, AUCinf
|
1219 h*ng/mL
Standard Deviation 346
|
5640 h*ng/mL
Standard Deviation 1123
|
16458 h*ng/mL
Standard Deviation 2580
|
|
Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 26, AUCinf
|
1225 h*ng/mL
Standard Deviation 389
|
4336 h*ng/mL
Standard Deviation 1021
|
12411 h*ng/mL
Standard Deviation 2597
|
PRIMARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: This outcome used the pharmacokinetic (PK) set. The PK set consisted of all subjects in the safety analysis set for whom at least 1 PK parameter could be calculated for METH or IXT-m200.
METH Cmax following IXT-m200 dosing on each METH Challenge Day.
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=18 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 1, Cmax
|
111 ng/mL
Standard Deviation 58
|
98 ng/mL
Standard Deviation 29
|
90 ng/mL
Standard Deviation 24
|
|
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 5, Cmax
|
103 ng/mL
Standard Deviation 56
|
312 ng/mL
Standard Deviation 37
|
759 ng/mL
Standard Deviation 135
|
|
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 12, Cmax
|
100 ng/mL
Standard Deviation 31
|
198 ng/mL
Standard Deviation 24
|
444 ng/mL
Standard Deviation 92
|
|
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 19, Cmax
|
96 ng/mL
Standard Deviation 36
|
168 ng/mL
Standard Deviation 24
|
340 ng/mL
Standard Deviation 57
|
|
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Day 26, Cmax
|
80 ng/mL
Standard Deviation 13
|
145 ng/mL
Standard Deviation 17
|
262 ng/mL
Standard Deviation 54
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for CRAVE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for CRAVE of METH Challenge Doses
Day 1
|
6601 score on a scale * min
Standard Deviation 4492
|
7040 score on a scale * min
Standard Deviation 6022
|
8658 score on a scale * min
Standard Deviation 5133
|
|
Change in Subjective Effects for CRAVE of METH Challenge Doses
Day 5
|
5758 score on a scale * min
Standard Deviation 4642
|
5837 score on a scale * min
Standard Deviation 5870
|
5980 score on a scale * min
Standard Deviation 4363
|
|
Change in Subjective Effects for CRAVE of METH Challenge Doses
Day 12
|
4587 score on a scale * min
Standard Deviation 4466
|
5544 score on a scale * min
Standard Deviation 6318
|
5532 score on a scale * min
Standard Deviation 3974
|
|
Change in Subjective Effects for CRAVE of METH Challenge Doses
Day 19
|
3456 score on a scale * min
Standard Deviation 4406
|
6457 score on a scale * min
Standard Deviation 6623
|
4426 score on a scale * min
Standard Deviation 4292
|
|
Change in Subjective Effects for CRAVE of METH Challenge Doses
Day 26
|
3044 score on a scale * min
Standard Deviation 3611
|
2374 score on a scale * min
Standard Deviation 2683
|
5716 score on a scale * min
Standard Deviation 9434
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for DISLIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Day 1
|
2124 score on a scale * min
Standard Deviation 2173
|
2806 score on a scale * min
Standard Deviation 4517
|
1697 score on a scale * min
Standard Deviation 2446
|
|
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Day 5
|
2021 score on a scale * min
Standard Deviation 2636
|
3331 score on a scale * min
Standard Deviation 3966
|
2523 score on a scale * min
Standard Deviation 3412
|
|
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Day 12
|
1998 score on a scale * min
Standard Deviation 2598
|
3393 score on a scale * min
Standard Deviation 5240
|
2292 score on a scale * min
Standard Deviation 3176
|
|
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Day 19
|
2089 score on a scale * min
Standard Deviation 2686
|
3433 score on a scale * min
Standard Deviation 5486
|
2888 score on a scale * min
Standard Deviation 4245
|
|
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Day 26
|
1610 score on a scale * min
Standard Deviation 2434
|
1925 score on a scale * min
Standard Deviation 3679
|
50520 score on a scale * min
Standard Deviation 6042
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for FEEL over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for FEEL of METH Challenge Doses
Day 1
|
5963 score on a scale * min
Standard Deviation 2731
|
10640 score on a scale * min
Standard Deviation 4839
|
8116 score on a scale * min
Standard Deviation 4242
|
|
Change in Subjective Effects for FEEL of METH Challenge Doses
Day 5
|
6470 score on a scale * min
Standard Deviation 3886
|
9923 score on a scale * min
Standard Deviation 5441
|
6822 score on a scale * min
Standard Deviation 4089
|
|
Change in Subjective Effects for FEEL of METH Challenge Doses
Day 12
|
5491 score on a scale * min
Standard Deviation 4370
|
9179 score on a scale * min
Standard Deviation 5318
|
7029 score on a scale * min
Standard Deviation 4597
|
|
Change in Subjective Effects for FEEL of METH Challenge Doses
Day 19
|
5827 score on a scale * min
Standard Deviation 4723
|
10086 score on a scale * min
Standard Deviation 5122
|
6078 score on a scale * min
Standard Deviation 4772
|
|
Change in Subjective Effects for FEEL of METH Challenge Doses
Day 26
|
5784 score on a scale * min
Standard Deviation 3992
|
7405 score on a scale * min
Standard Deviation 4315
|
9277 score on a scale * min
Standard Deviation 7464
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for GOOD over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for GOOD of METH Challenge Doses
Day 1
|
6151 score on a scale * min
Standard Deviation 2872
|
10984 score on a scale * min
Standard Deviation 5214
|
8378 score on a scale * min
Standard Deviation 3766
|
|
Change in Subjective Effects for GOOD of METH Challenge Doses
Day 5
|
6555 score on a scale * min
Standard Deviation 4260
|
9783 score on a scale * min
Standard Deviation 5185
|
6903 score on a scale * min
Standard Deviation 3820
|
|
Change in Subjective Effects for GOOD of METH Challenge Doses
Day 12
|
5584 score on a scale * min
Standard Deviation 4498
|
9236 score on a scale * min
Standard Deviation 5083
|
7001 score on a scale * min
Standard Deviation 4211
|
|
Change in Subjective Effects for GOOD of METH Challenge Doses
Day 19
|
6138 score on a scale * min
Standard Deviation 5393
|
10016 score on a scale * min
Standard Deviation 5209
|
5238 score on a scale * min
Standard Deviation 3999
|
|
Change in Subjective Effects for GOOD of METH Challenge Doses
Day 26
|
6335 score on a scale * min
Standard Deviation 5099
|
7468 score on a scale * min
Standard Deviation 3443
|
6760 score on a scale * min
Standard Deviation 6967
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for HIGH over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for HIGH of METH Challenge Doses
Day 1
|
5873 score on a scale * min
Standard Deviation 2671
|
10599 score on a scale * min
Standard Deviation 4871
|
7947 score on a scale * min
Standard Deviation 4218
|
|
Change in Subjective Effects for HIGH of METH Challenge Doses
Day 5
|
6187 score on a scale * min
Standard Deviation 3744
|
9765 score on a scale * min
Standard Deviation 5441
|
6813 score on a scale * min
Standard Deviation 4046
|
|
Change in Subjective Effects for HIGH of METH Challenge Doses
Day 12
|
5117 score on a scale * min
Standard Deviation 4420
|
9162 score on a scale * min
Standard Deviation 5245
|
6973 score on a scale * min
Standard Deviation 4583
|
|
Change in Subjective Effects for HIGH of METH Challenge Doses
Day 19
|
5494 score on a scale * min
Standard Deviation 4916
|
9740 score on a scale * min
Standard Deviation 5366
|
6018 score on a scale * min
Standard Deviation 4700
|
|
Change in Subjective Effects for HIGH of METH Challenge Doses
Day 26
|
5603 score on a scale * min
Standard Deviation 3980
|
7562 score on a scale * min
Standard Deviation 4542
|
9690 score on a scale * min
Standard Deviation 7217
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for LIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for LIKE of METH Challenge Doses
Day 1
|
7495 score on a scale * min
Standard Deviation 3870
|
11322 score on a scale * min
Standard Deviation 4276
|
9858 score on a scale * min
Standard Deviation 3635
|
|
Change in Subjective Effects for LIKE of METH Challenge Doses
Day 5
|
7582 score on a scale * min
Standard Deviation 4437
|
9668 score on a scale * min
Standard Deviation 4997
|
7430 score on a scale * min
Standard Deviation 4126
|
|
Change in Subjective Effects for LIKE of METH Challenge Doses
Day 12
|
6394 score on a scale * min
Standard Deviation 5089
|
9498 score on a scale * min
Standard Deviation 5002
|
7111 score on a scale * min
Standard Deviation 4001
|
|
Change in Subjective Effects for LIKE of METH Challenge Doses
Day 19
|
6420 score on a scale * min
Standard Deviation 5633
|
10271 score on a scale * min
Standard Deviation 5432
|
6027 score on a scale * min
Standard Deviation 3905
|
|
Change in Subjective Effects for LIKE of METH Challenge Doses
Day 26
|
7354 score on a scale * min
Standard Deviation 5345
|
7713 score on a scale * min
Standard Deviation 2827
|
6811 score on a scale * min
Standard Deviation 7344
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for MORE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for MORE of METH Challenge Doses
Day 1
|
9469 score on a scale * min
Standard Deviation 4254
|
9404 score on a scale * min
Standard Deviation 5347
|
11164 score on a scale * min
Standard Deviation 4365
|
|
Change in Subjective Effects for MORE of METH Challenge Doses
Day 5
|
8582 score on a scale * min
Standard Deviation 4853
|
7341 score on a scale * min
Standard Deviation 5671
|
7796 score on a scale * min
Standard Deviation 4303
|
|
Change in Subjective Effects for MORE of METH Challenge Doses
Day 12
|
6629 score on a scale * min
Standard Deviation 5306
|
7734 score on a scale * min
Standard Deviation 6017
|
7802 score on a scale * min
Standard Deviation 3954
|
|
Change in Subjective Effects for MORE of METH Challenge Doses
Day 19
|
5654 score on a scale * min
Standard Deviation 5911
|
8521 score on a scale * min
Standard Deviation 6584
|
5603 score on a scale * min
Standard Deviation 4593
|
|
Change in Subjective Effects for MORE of METH Challenge Doses
Day 26
|
6801 score on a scale * min
Standard Deviation 6021
|
4059 score on a scale * min
Standard Deviation 4201
|
5273 score on a scale * min
Standard Deviation 8644
|
SECONDARY outcome
Timeframe: Day 1, 5, 12, 19, and 26Population: The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for STIMULATED over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=16 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Day 1
|
6155 score on a scale * min
Standard Deviation 3245
|
11041 score on a scale * min
Standard Deviation 4934
|
8231 score on a scale * min
Standard Deviation 4259
|
|
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Day 5
|
6108 score on a scale * min
Standard Deviation 3615
|
9902 score on a scale * min
Standard Deviation 5445
|
6885 score on a scale * min
Standard Deviation 3915
|
|
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Day 12
|
5407 score on a scale * min
Standard Deviation 4279
|
9502 score on a scale * min
Standard Deviation 5234
|
6913 score on a scale * min
Standard Deviation 4448
|
|
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Day 19
|
5643 score on a scale * min
Standard Deviation 4387
|
10314 score on a scale * min
Standard Deviation 5130
|
5764 score on a scale * min
Standard Deviation 4707
|
|
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Day 26
|
5777 score on a scale * min
Standard Deviation 3498
|
7062 score on a scale * min
Standard Deviation 4436
|
9435 score on a scale * min
Standard Deviation 7499
|
SECONDARY outcome
Timeframe: 126 daysPopulation: All subjects who received a dose of IXT-m200 or placebo on Day 4.
Number of serious adverse events (SAEs) as identified by physical examinations and vital sign, adverse event, ECG, and clinical laboratory testing, and immune response by measurement of anti-IXT-m200 antibody levels.
Outcome measures
| Measure |
Placebo
n=20 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=18 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
n=18 Participants
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Safety and Tolerability of IXT-m200 Followed by METH Challenges
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 122 daysPopulation: All subjects who had quantifiable serum concentrations of IXT-m200 above the lower limit of quantitation (\<1250 ng/mL) starting at the first time point within 2.25 hr post-dose.
Measured by serum concentrations of IXT-m200 over time
Outcome measures
| Measure |
Placebo
n=18 Participants
Normal Saline
|
IXT-m200, 6 mg/kg
n=18 Participants
Single 6 mg/kg intravenous dose of IXT-m200
|
IXT-m200, 20 mg/kg
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|
|
Pharmacokinetics of IXT-m200 Following Single Administration
Pre-dose
|
617.1589 ng/mL
Standard Deviation 2310.85995
|
101.9665 ng/mL
Standard Deviation 432.60722
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
2.25 hr
|
148344.5945 ng/mL
Standard Deviation 36757.72368
|
437078.0551 ng/mL
Standard Deviation 86546.28544
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
4 hr
|
146618.9207 ng/mL
Standard Deviation 31767.42539
|
413372.2737 ng/mL
Standard Deviation 86725.33552
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
6 hr
|
136095.9889 ng/mL
Standard Deviation 38937.85634
|
399030.4857 ng/mL
Standard Deviation 80456.98764
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
12 hr
|
129181.7595 ng/mL
Standard Deviation 34383.49379
|
357523.6776 ng/mL
Standard Deviation 66912.58267
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
24 hr
|
104920.1213 ng/mL
Standard Deviation 16662.63925
|
308379.4673 ng/mL
Standard Deviation 51024.44575
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
72 hr
|
80955.9851 ng/mL
Standard Deviation 14213.86691
|
261876.2091 ng/mL
Standard Deviation 105541.51539
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
192 hr
|
52338.2686 ng/mL
Standard Deviation 10831.30591
|
165650.1889 ng/mL
Standard Deviation 43060.62407
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
360 hr
|
41457.508 ng/mL
Standard Deviation 6880.32292
|
119773.4315 ng/mL
Standard Deviation 26091.50216
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
528 hr
|
30996.9615 ng/mL
Standard Deviation 4340.51769
|
84460.7453 ng/mL
Standard Deviation 12052.38197
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
576 hr
|
28816.8833 ng/mL
Standard Deviation 4801.42874
|
93827.4756 ng/mL
Standard Deviation 28503.81089
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
744 hr
|
22375.2957 ng/mL
Standard Deviation 8092.25642
|
73363.3274 ng/mL
Standard Deviation 22594.3438
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
912 hr
|
16793.6838 ng/mL
Standard Deviation 4465.29642
|
61311.3385 ng/mL
Standard Deviation 20125.59405
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
1080 hr
|
12230.3541 ng/mL
Standard Deviation 3819.65649
|
45940.3791 ng/mL
Standard Deviation 12826.46281
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
1248 hr
|
10954.1343 ng/mL
Standard Deviation 3596.63207
|
38972.226 ng/mL
Standard Deviation 11834.15391
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
1416 hr
|
8321.6347 ng/mL
Standard Deviation 2654.52136
|
29865.3018 ng/mL
Standard Deviation 10122.90309
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
1920 hr
|
4493.8091 ng/mL
Standard Deviation 2547.2715
|
16676.9182 ng/mL
Standard Deviation 7385.34675
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
2424 hr
|
2093.7292 ng/mL
Standard Deviation 1803.09651
|
10002.5426 ng/mL
Standard Deviation 4197.70821
|
—
|
|
Pharmacokinetics of IXT-m200 Following Single Administration
2928 hr
|
1128.2148 ng/mL
Standard Deviation 1846.27013
|
5226.7547 ng/mL
Standard Deviation 2209.49318
|
—
|
Adverse Events
All Subjects: Day 1-3
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo: Day 4-126
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
IXT-m200, 6 mg/kg: Day 4-126
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
IXT-m200, 20 mg/kg: Day 4-126
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects: Day 1-3
n=77 participants at risk
No Investigational Product administration; subjects were administered 30 mg METH and saline on Day 1 for drug discrimination.
|
Placebo: Day 4-126
n=20 participants at risk
Normal saline
Placebo: Normal saline
|
IXT-m200, 6 mg/kg: Day 4-126
n=18 participants at risk
Single 6 mg/kg intravenous dose of IXT-m200
IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody
|
IXT-m200, 20 mg/kg: Day 4-126
n=18 participants at risk
Single 20 mg/kg intravenous dose of IXT-m200
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
18.2%
14/77 • 126 days
|
40.0%
8/20 • 126 days
|
38.9%
7/18 • 126 days
|
44.4%
8/18 • 126 days
|
|
Cardiac disorders
Tachycardia
|
9.1%
7/77 • 126 days
|
15.0%
3/20 • 126 days
|
44.4%
8/18 • 126 days
|
27.8%
5/18 • 126 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Ear and labyrinth disorders
Ear pruritis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Ear and labyrinth disorders
Eye irritation
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Ear and labyrinth disorders
Scleral haemorrhage
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Ear and labyrinth disorders
Scleral disorder
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Ear and labyrinth disorders
Vision blurred
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Ear and labyrinth disorders
Visual impairment
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Gastrointestinal disorders
Dry mouth
|
10.4%
8/77 • 126 days
|
25.0%
5/20 • 126 days
|
16.7%
3/18 • 126 days
|
16.7%
3/18 • 126 days
|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77 • 126 days
|
20.0%
4/20 • 126 days
|
11.1%
2/18 • 126 days
|
27.8%
5/18 • 126 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.9%
3/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
11.1%
2/18 • 126 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
11.1%
2/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
2/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
11.1%
2/18 • 126 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Hepatobiliary disorders
Abdominal distension
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Gastrointestinal disorders
Submaxillary gland enlargement
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Injection site pain
|
13.0%
10/77 • 126 days
|
20.0%
4/20 • 126 days
|
27.8%
5/18 • 126 days
|
33.3%
6/18 • 126 days
|
|
General disorders
Catheter site pain
|
3.9%
3/77 • 126 days
|
25.0%
5/20 • 126 days
|
11.1%
2/18 • 126 days
|
16.7%
3/18 • 126 days
|
|
General disorders
Feeling hot
|
19.5%
15/77 • 126 days
|
20.0%
4/20 • 126 days
|
16.7%
3/18 • 126 days
|
16.7%
3/18 • 126 days
|
|
General disorders
Influenza like illness
|
0.00%
0/77 • 126 days
|
15.0%
3/20 • 126 days
|
11.1%
2/18 • 126 days
|
11.1%
2/18 • 126 days
|
|
General disorders
Fatigue
|
5.2%
4/77 • 126 days
|
15.0%
3/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Feeling abnormal
|
5.2%
4/77 • 126 days
|
10.0%
2/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Energy increased
|
7.8%
6/77 • 126 days
|
5.0%
1/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Chills
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Feeling of relaxation
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Infusion site pain
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Pain
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Catheter site inflammation
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Catheter site nodule
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Chest discomfort
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Injection site erythema
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
General disorders
Medical device site reaction
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
16.7%
3/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Infections and infestations
Rash pustular
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
11.1%
2/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.3%
1/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Heart rate increased
|
1.3%
1/77 • 126 days
|
15.0%
3/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Weight decreased
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
2/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
11.1%
2/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Headache
|
11.7%
9/77 • 126 days
|
55.0%
11/20 • 126 days
|
33.3%
6/18 • 126 days
|
33.3%
6/18 • 126 days
|
|
Nervous system disorders
Paraesthesia
|
6.5%
5/77 • 126 days
|
5.0%
1/20 • 126 days
|
33.3%
6/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Dizziness
|
9.1%
7/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Tremor
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
11.1%
2/18 • 126 days
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Restless legs syndrome
|
1.3%
1/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Vibratory sense increased
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Euphoric mood
|
48.1%
37/77 • 126 days
|
80.0%
16/20 • 126 days
|
83.3%
15/18 • 126 days
|
72.2%
13/18 • 126 days
|
|
Psychiatric disorders
Hypervigilance
|
26.0%
20/77 • 126 days
|
50.0%
10/20 • 126 days
|
55.6%
10/18 • 126 days
|
33.3%
6/18 • 126 days
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/77 • 126 days
|
5.0%
1/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Bruxism
|
7.8%
6/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Logorrhoea
|
3.9%
3/77 • 126 days
|
5.0%
1/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Disturbance in sexual arousal
|
2.6%
2/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Restlessness
|
5.2%
4/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.7%
9/77 • 126 days
|
25.0%
5/20 • 126 days
|
38.9%
7/18 • 126 days
|
16.7%
3/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
11.1%
2/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
1/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Blister rupture
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Social circumstances
Drug abuser
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
0.00%
0/18 • 126 days
|
5.6%
1/18 • 126 days
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/77 • 126 days
|
10.0%
2/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/77 • 126 days
|
0.00%
0/20 • 126 days
|
5.6%
1/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Vascular disorders
Hypertension
|
1.3%
1/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Vascular disorders
Vasculitis
|
0.00%
0/77 • 126 days
|
5.0%
1/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Discomfort
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
General disorders
Thirst
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Electrocardiogram ST segment depression
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Electrocardiogram ST-T change
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Investigations
Hepatic enzyme increased
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Disgeusia
|
2.6%
2/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Hyperaesthesia
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Nervous system disorders
Migraine with aura
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Psychiatric disorders
Change in sustained attention
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Vascular disorders
Hot flush
|
3.9%
3/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
|
Vascular disorders
Flushing
|
1.3%
1/77 • 126 days
|
0.00%
0/20 • 126 days
|
0.00%
0/18 • 126 days
|
0.00%
0/18 • 126 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor agrees that the Investigator may present and publish methods and results of the study, but only after Sponsor has first published the results and with Sponsor's written permission. PRA shall provide to Sponsor any proposed presentation or publication for review 30 days prior to submission so that Sponsor may review for accuracy and provide comments and/or remove its proprietary or confidential information. PRA agrees that all reasonable comments will be incorporated.
- Publication restrictions are in place
Restriction type: OTHER