Trial Outcomes & Findings for The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment (NCT NCT01655823)
NCT ID: NCT01655823
Last Updated: 2018-10-30
Results Overview
The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Day 22 to Day 28
Results posted on
2018-10-30
Participant Flow
Participant milestones
| Measure |
Placebo (Twice Daily)
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
24
|
25
|
26
|
|
Overall Study
COMPLETED
|
25
|
23
|
24
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Twice Daily)
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
Baseline characteristics by cohort
| Measure |
Placebo (Twice Daily)
n=25 Participants
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
n=25 Participants
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
n=24 Participants
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
n=25 Participants
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
n=26 Participants
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 10.29 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 10.28 • n=4 Participants
|
60.6 years
STANDARD_DEVIATION 11.05 • n=21 Participants
|
60.1 years
STANDARD_DEVIATION 10.28 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
77 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
24 participants
n=5 Participants
|
25 participants
n=4 Participants
|
26 participants
n=21 Participants
|
125 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 22 to Day 28Population: ITT
The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).
Outcome measures
| Measure |
Placebo (Twice Daily)
n=25 Participants
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
n=25 Participants
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
n=24 Participants
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
n=25 Participants
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
n=26 Participants
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
|---|---|---|---|---|---|
|
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Mean Scores for Days 22-28
|
5.323 11 point units on a scale
Standard Deviation 2.2765
|
5.005 11 point units on a scale
Standard Deviation 2.0451
|
5.987 11 point units on a scale
Standard Deviation 2.2531
|
4.566 11 point units on a scale
Standard Deviation 2.4931
|
4.749 11 point units on a scale
Standard Deviation 1.7701
|
|
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Change from Baseline in Mean Scores for Days 22-28
|
-1.339 11 point units on a scale
Standard Deviation 2.0681
|
-1.269 11 point units on a scale
Standard Deviation 1.3959
|
-1.052 11 point units on a scale
Standard Deviation 1.5742
|
-1.682 11 point units on a scale
Standard Deviation 2.3231
|
-1.529 11 point units on a scale
Standard Deviation 1.8203
|
|
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Baseline
|
6.662 11 point units on a scale
Standard Deviation 1.4832
|
6.285 11 point units on a scale
Standard Deviation 1.3312
|
7.012 11 point units on a scale
Standard Deviation 1.3706
|
6.240 11 point units on a scale
Standard Deviation 1.1743
|
6.255 11 point units on a scale
Standard Deviation 1.3561
|
Adverse Events
Placebo (Twice Daily)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Low Dose Tetrodotoxin (Twice Daily)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Mid-range Dose of Tetrodotoxin (Twice Daily)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Max Dose Tetrodotoxin (Once Daily)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Max Dose Tetrodotoxin (Twice Daily)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Twice Daily)
n=25 participants at risk
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
n=25 participants at risk
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
n=24 participants at risk
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
n=25 participants at risk
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
n=26 participants at risk
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of bladder and Prostate cancer
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/26
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/25
|
3.8%
1/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/26
|
Other adverse events
| Measure |
Placebo (Twice Daily)
n=25 participants at risk
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo: Sham treatment acting as control arm
|
Low Dose Tetrodotoxin (Twice Daily)
n=25 participants at risk
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Mid-range Dose of Tetrodotoxin (Twice Daily)
n=24 participants at risk
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Once Daily)
n=25 participants at risk
Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.
Placebo: Sham treatment acting as control arm
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
Max Dose Tetrodotoxin (Twice Daily)
n=26 participants at risk
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
|
|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia
|
24.0%
6/25
|
20.0%
5/25
|
29.2%
7/24
|
20.0%
5/25
|
38.5%
10/26
|
|
Nervous system disorders
Hypoaesthesia
|
8.0%
2/25
|
8.0%
2/25
|
4.2%
1/24
|
8.0%
2/25
|
3.8%
1/26
|
|
Nervous system disorders
headache
|
20.0%
5/25
|
24.0%
6/25
|
12.5%
3/24
|
4.0%
1/25
|
34.6%
9/26
|
|
Nervous system disorders
dizziness
|
20.0%
5/25
|
12.0%
3/25
|
16.7%
4/24
|
12.0%
3/25
|
30.8%
8/26
|
|
Nervous system disorders
Paraesthesia Oral
|
12.0%
3/25
|
16.0%
4/25
|
37.5%
9/24
|
40.0%
10/25
|
42.3%
11/26
|
|
Nervous system disorders
Hypoaesthesia Oral
|
12.0%
3/25
|
20.0%
5/25
|
29.2%
7/24
|
24.0%
6/25
|
38.5%
10/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60