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Evaluating Muscle Weakness Improvement With Lorcaserin in ICU (EMILI)

Primary Purpose

Muscle Weakness, Sepsis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years old
  • Sepsis [ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or suspected infection]
  • Muscle weakness [Medical Research Council sum score <48/60 or handgrip strength <11 kg in men and <7 kg in women]
  • Obey Commands [Score for DeJonghe Awakening Score of ≥3/5]

Exclusion Criteria:

  • Severe renal insufficiency [Creatinine Clearance <30 mL/min - or receiving dialysis]
  • Acute infectious or auto-immune hepatitis, acute liver failure or a history of cirrhosis without liver transplant
  • History of psychosis
  • Bradycardia, or 2nd or 3rd degree Atrio-Ventricular block without pacemaker
  • History of valvular heart disease without valve replacement
  • History of priapism
  • Pre-existing cognitive impairment
  • Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be substituted stopped or titrated.
  • Receiving Sulfonylurea medication at the time of the study
  • Prior neuromuscular or central nervous system disease, including pre-existing neuropathy
  • Inability to perform study's muscle strength assessments based on patient's baseline status prior to hospital admission
  • Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia, or infarction; short gut syndrome)
  • Body mass index >40
  • Patient not expected to survive >4 days
  • Pregnancy or lactation
  • Allergy to lorcaserin or lorcaserin taken in the prior 7 days
  • Enrolled in another interventional drug or physical rehabilitation trial
  • Physician declines for patient to be enrolled
  • Patient or proxy declines consent
  • Unable to reach proxy for consent
  • Non-English speaking

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.

Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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).
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).
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.

Full Information

First Posted
August 11, 2015
Last Updated
December 26, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02523690
Brief Title
Evaluating Muscle Weakness Improvement With Lorcaserin in ICU
Acronym
EMILI
Official Title
Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment of eligible patients
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Intervention Description
10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral or enteral, single dose. Oral or enteral, single dose two days later
Primary Outcome Measure Information:
Title
Change in Handgrip Strength as Measured by Hand Dynamometer
Description
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
Secondary Outcome Measure Information:
Title
Change in Handgrip Strength as Measured by Hand Dynamometer
Description
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
Title
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
Description
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
Title
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
Description
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
Title
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Description
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Time Frame
Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Title
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Description
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Time Frame
Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old Sepsis [ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or suspected infection] Muscle weakness [Medical Research Council sum score <48/60 or handgrip strength <11 kg in men and <7 kg in women] Obey Commands [Score for DeJonghe Awakening Score of ≥3/5] Exclusion Criteria: Severe renal insufficiency [Creatinine Clearance <30 mL/min - or receiving dialysis] Acute infectious or auto-immune hepatitis, acute liver failure or a history of cirrhosis without liver transplant History of psychosis Bradycardia, or 2nd or 3rd degree Atrio-Ventricular block without pacemaker History of valvular heart disease without valve replacement History of priapism Pre-existing cognitive impairment Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be substituted stopped or titrated. Receiving Sulfonylurea medication at the time of the study Prior neuromuscular or central nervous system disease, including pre-existing neuropathy Inability to perform study's muscle strength assessments based on patient's baseline status prior to hospital admission Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia, or infarction; short gut syndrome) Body mass index >40 Patient not expected to survive >4 days Pregnancy or lactation Allergy to lorcaserin or lorcaserin taken in the prior 7 days Enrolled in another interventional drug or physical rehabilitation trial Physician declines for patient to be enrolled Patient or proxy declines consent Unable to reach proxy for consent Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale M Needham, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

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