A Phase 1/2 interventional study of Lorcaserin and Placebo in Muscle Weakness and Sepsis, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Johns Hopkins University · Phase 1/2, Interventional, and Treatment
ICU acquired muscle weakness is a significant problem in patients recovering from critical illness. This trial will evaluate the safety and efficacy of a drug in improving muscle weakness in critically ill patients.
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's enrollment of 5 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Drug: Lorcaserin
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Drug: Placebo
10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
Oral or enteral, single dose. Oral or enteral, single dose two days later
Change in Handgrip Strength as Measured by Hand Dynamometer
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)
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Handgrip Strength as Measured by Hand Dynamometer
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)
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
Measuring 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).
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
Measuring 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).
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
| Milestone | Intervention | Control |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
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)
| percent of predicted strength | Intervention | Control |
|---|---|---|
| Change in Handgrip Strength as Measured by Hand Dynamometer | 0.67 ± 2.93 | 1.75 ± 1.06 |
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)
| percent of predicted strength | Intervention | Control |
|---|---|---|
| Change in Handgrip Strength as Measured by Hand Dynamometer | -3.83 ± 1.89 | 2.25 ± 0.35 |
Measuring 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).
| score on a scale | Intervention | Control |
|---|---|---|
| Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score | 0.33 ± 3.5 | 3.50 ± 2.12 |
Measuring 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).
| score on a scale | Intervention | Control |
|---|---|---|
| Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score | 1.00 ± 1.73 | 0.50 ± 0.71 |
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
| kilograms | Intervention | Control |
|---|---|---|
| Change in Quadriceps Strength as Measured by Handheld Dynamometer | -0.23 ± 1.83 | 4.15 ± 2.19 |
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
| kilograms | Intervention | Control |
|---|---|---|
| Change in Quadriceps Strength as Measured by Handheld Dynamometer | 0.02 ± 1.23 | 2.13 ± 5.76 |
Collected over While admitted in hospital. For the 5 participants in this study, the mean number of days between enrollment and hospital discharge is 17.6 days (standard deviation 12.9 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Control | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 63.7 ± 19.8 | 56.0 ± 18.4 | 60.6 ± 17.2 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University