Trial Outcomes & Findings for A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL (NCT NCT02598622)
NCT ID: NCT02598622
Last Updated: 2017-03-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Days 1 - 21
Results posted on
2017-03-03
Participant Flow
Participant milestones
| Measure |
Acetyl-L-Carnitine Only
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
|
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Acetyl-L-Carnitine Only
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
|
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Baseline characteristics by cohort
| Measure |
Acetyl-L-Carnitine Only
n=8 Participants
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
|
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8 years
n=5 Participants
|
—
|
8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 21Population: Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.
Outcome measures
Outcome data not reported
Adverse Events
Acetyl-L-Carnitine Only
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Acetyl-L-Carnitine or Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetyl-L-Carnitine Only
n=8 participants at risk
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
|
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21.
|
|---|---|---|
|
Vascular disorders
Hospitalization
|
12.5%
1/8 • Number of events 1 • 60 days
|
—
0/0 • 60 days
|
Other adverse events
| Measure |
Acetyl-L-Carnitine Only
n=8 participants at risk
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
|
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21.
|
|---|---|---|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
100.0%
8/8 • Number of events 16 • 60 days
|
—
0/0 • 60 days
|
|
Blood and lymphatic system disorders
Low Platelets
|
100.0%
8/8 • Number of events 14 • 60 days
|
—
0/0 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 2 • 60 days
|
—
0/0 • 60 days
|
|
Musculoskeletal and connective tissue disorders
pain
|
12.5%
1/8 • Number of events 1 • 60 days
|
—
0/0 • 60 days
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.5%
1/8 • Number of events 1 • 60 days
|
—
0/0 • 60 days
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
62.5%
5/8 • Number of events 5 • 60 days
|
—
0/0 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place