Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

NCT ID: NCT02523690

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Muscle Weakness; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Lorcaserin

Intervention Type: DRUG

10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral or enteral, single dose. Oral or enteral, single dose two days later

Interventions

Lorcaserin

10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later

Intervention Type: DRUG

Placebo

Oral or enteral, single dose. Oral or enteral, single dose two days later

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale M Needham, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR001079

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00072940

Identifier Type: -

Identifier Source: org_study_id