Evaluating Muscle Weakness Improvement With Lorcaserin in ICU (EMILI)

Johns Hopkins University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Muscle Weakness; Sepsis

Treatments: Drug: Lorcaserin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02523690

IRB00072940

UL1TR001079 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Lorcaserin

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo