Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

NCT02523690 | Terminated Phase 1 Results

• 2 other identifiers: IRB00072940UL1TR001079
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Handgrip Strength as Measured by Hand Dynamometer

  Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo

• Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score

  Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo

• Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score

  Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo

• Change in Quadriceps Strength as Measured by Handheld Dynamometer

  Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo

• Change in Quadriceps Strength as Measured by Handheld Dynamometer

  Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Lorcaserin

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lorcaserin DRUG

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

Intervention

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Muscle Weakness; Sepsis

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Results Point of Contact

• Title: Dr. Dale Needham
• Organization: Johns Hopkins University

dale.needham@jhmi.edu

410-287-3343

Study Officials

• Dale M Needham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 14, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Locations

US (1)