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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001079 | U.S. NIH Grant/Contract | View source |
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Slow recruitment of eligible patients
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm. |
|
| Control | Placebo Comparator | Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug | 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale M Needham, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | percent of predicted strength | Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dale Needham | Johns Hopkins University | 410-287-3343 | dale.needham@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2017 | Dec 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Placebo | Drug | 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 |
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). |
| 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). | 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. | 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. | Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | percent of predicted strength | Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo |
|
|
|
| Secondary | Change in Quadriceps Strength as Measured by Handheld Dynamometer | Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle. | Posted | Mean | Standard Deviation | kilograms | Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo |
|
|
|
| Secondary | Change in Quadriceps Strength as Measured by Handheld Dynamometer | Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle. | Posted | Mean | Standard Deviation | kilograms | Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |