Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Muscle Weakness, Sepsis

In brief

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.

Key facts

Study ID

NCT02523690

Run by

Johns Hopkins University

People needed

5

Starts

2015-12-01

Expected to finish

2017-12-01

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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