Trial Outcomes & Findings for Lidocaine for Oxaliplatin-induced Neuropathy (NCT NCT03254394)
NCT ID: NCT03254394
Last Updated: 2022-03-09
Results Overview
The intensity of cold pain and cold unpleasantness is evaluated separately, assessed daily on a 0-10 scale, upon holding a pre-cooled (\~8°C) metal cylinder for 10 seconds. the area under the curve of cold pain and cold unpleasantness vs time is calculated per chemotherapy cycle (every two weeks) and serves as a primary outcome measure. For intervention (lidocaine+FOLFOX) and control (placebo+FOLFOX) groups, the average of cold pain AUC and cold unpleasantness AUC over 7 cycles was calculated. The average AUCs over 7 cycles were compared between study arms. The AUC is measured as a score on a 0-10 scale multiplied by 14 days and may range between 0 and 140. Higher AUC values represent more intense cold pain/unpleasantness.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
14 weeks
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Placebo + FOLFOX
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo + FOLFOX
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Lidocaine for Oxaliplatin-induced Neuropathy
Baseline characteristics by cohort
| Measure |
Placebo + FOLFOX
n=12 Participants
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=14 Participants
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: data for 14 days following the 6th cycle was collected and analyzed.
The intensity of cold pain and cold unpleasantness is evaluated separately, assessed daily on a 0-10 scale, upon holding a pre-cooled (\~8°C) metal cylinder for 10 seconds. the area under the curve of cold pain and cold unpleasantness vs time is calculated per chemotherapy cycle (every two weeks) and serves as a primary outcome measure. For intervention (lidocaine+FOLFOX) and control (placebo+FOLFOX) groups, the average of cold pain AUC and cold unpleasantness AUC over 7 cycles was calculated. The average AUCs over 7 cycles were compared between study arms. The AUC is measured as a score on a 0-10 scale multiplied by 14 days and may range between 0 and 140. Higher AUC values represent more intense cold pain/unpleasantness.
Outcome measures
| Measure |
Placebo + FOLFOX
n=12 Participants
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=12 Participants
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time
pain AUC
|
16.4 score on a scale*days
Standard Deviation 18.3
|
9.5 score on a scale*days
Standard Deviation 14.4
|
|
Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time
unpleasantness AUC
|
33.1 score on a scale*days
Standard Deviation 27.8
|
25.4 score on a scale*days
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: 12 weeks and 34-36 weeksPopulation: Patients in each group who had corresponding visit data
Change in CIPN (Chemotherapy-induced peripheral Neuropathy) score (on EORTC QLQ-CIPN20 tool ) from baseline to the Cycle 6 (12 weeks), and from baseline to last follow-up (34-36 weeks). EORTC QLQ-CIPN20 ranges from 0 (no symptoms) to 100 (worst symptoms). A higher score represents worse neuropathy. The changes in scores are compared between study arms. EORTC QLQ-CIPN20 tool is a quality of life questionnaire (QLQ) from the European Organization for Research and Treatment of Cancer (EORTC) for evaluation of CIPN.
Outcome measures
| Measure |
Placebo + FOLFOX
n=12 Participants
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=12 Participants
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
CIPN Score on EORTC QLQ-CIPN20
12
|
2 score on a scale
Interval 0.0 to 8.3
|
4 score on a scale
Interval 0.0 to 4.0
|
|
CIPN Score on EORTC QLQ-CIPN20
34-36 weeks
|
17.0 score on a scale
Interval 5.5 to 39.8
|
37.0 score on a scale
Interval 7.4 to 47.2
|
SECONDARY outcome
Timeframe: 6 weeks, 12 weeks, 34-36 weeksChanges in Neuropathic Pain Symptom Inventory (NPSI) descriptors of neuropathic pain over time from baseline to cycle 3(6 weeks), cycle 6 (12 weeks), and the last follow-up (34-36 weeks). The total NPSI score ranges from 0 to 100; a higher NPSI total score represents a worse neuropathy outcome. The changes in scores from baseline are compared between study arms.
Outcome measures
| Measure |
Placebo + FOLFOX
n=12 Participants
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=12 Participants
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
Changes in NPSI Score.
12 weeks visit
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Changes in NPSI Score.
last follow-up visit
|
3.0 score on a scale
Interval 0.8 to 7.3
|
13.5 score on a scale
Interval 0.0 to 17.3
|
|
Changes in NPSI Score.
6 weeks visit
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 weeksThe cumulative dose of oxaliplatin received over the course (up to 12 cycles) of mFOLFOX6 treatment regimen. It corresponds to the absolute summed up quantity of Oxaliplatin administered to the patient over time. There is no range for this measure. Since this is a dose-limiting neuropathy prevention study, the higher value can be interpreted as better outcome.
Outcome measures
| Measure |
Placebo + FOLFOX
n=12 Participants
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=12 Participants
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
The Cumulative Dose of Oxaliplatin
|
1161.8 mg
Standard Deviation 300.2
|
1294.8 mg
Standard Deviation 221.6
|
Adverse Events
Placebo + FOLFOX
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Lidocaine + FOLFOX
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo + FOLFOX
n=12 participants at risk
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
Lidocaine + FOLFOX
n=14 participants at risk
Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
33.3%
4/12 • Number of events 14 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
28.6%
4/14 • Number of events 14 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
14.3%
2/14 • Number of events 5 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Cardiac disorders
Arrhythmia
|
16.7%
2/12 • Number of events 2 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 3 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
42.9%
6/14 • Number of events 12 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Nervous system disorders
Lightheadedness
|
8.3%
1/12 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
14.3%
2/14 • Number of events 4 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Skin and subcutaneous tissue disorders
Itching
|
16.7%
2/12 • Number of events 2 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
7.1%
1/14 • Number of events 1 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
21.4%
3/14 • Number of events 3 • 16 weeks
Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease. For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.
|
Additional Information
Simon Haroutounian, PhD. Associate Professor
Washington University in St Louis
Phone: 3132861715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place