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Evaluating Muscle Weakness Improvement With Lorcaserin in ICU (EMILI)

Johns Hopkins University logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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