Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

Sepsis Clinical Trial

— EMILI  

Official title:

Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02523690
• Other study ID #: IRB00072940
• Secondary ID: UL1TR001079
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Sepsis

Intervention

Drug:
• Lorcaserin
10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
• Placebo
Oral or enteral, single dose. Oral or enteral, single dose two days later

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
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)	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).	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).	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.	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.	Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo