Trial Outcomes & Findings for Evaluating Muscle Weakness Improvement With Lorcaserin in ICU (NCT NCT02523690)
NCT ID: NCT02523690
Last Updated: 2020-01-13
Results Overview
Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
Intervention
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Muscle Weakness Improvement With Lorcaserin in ICU
Baseline characteristics by cohort
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 19.8 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 18.4 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placeboHand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Handgrip Strength as Measured by Hand Dynamometer
|
0.67 percent of predicted strength
Standard Deviation 2.93
|
1.75 percent of predicted strength
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placeboHand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Handgrip Strength as Measured by Hand Dynamometer
|
-3.83 percent of predicted strength
Standard Deviation 1.89
|
2.25 percent of predicted strength
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placeboMeasuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
|
0.33 score on a scale
Standard Deviation 3.5
|
3.50 score on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placeboMeasuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
|
1.00 score on a scale
Standard Deviation 1.73
|
0.50 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placeboStrength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Quadriceps Strength as Measured by Handheld Dynamometer
|
-0.23 kilograms
Standard Deviation 1.83
|
4.15 kilograms
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placeboStrength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Outcome measures
| Measure |
Intervention
n=3 Participants
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
|
Control
n=2 Participants
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later
|
|---|---|---|
|
Change in Quadriceps Strength as Measured by Handheld Dynamometer
|
0.02 kilograms
Standard Deviation 1.23
|
2.13 kilograms
Standard Deviation 5.76
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place