Clinical trial NCT02523690: Evaluating Muscle Weakness Improvement With Lorcaserin in ICU
Official title: Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Muscle Weakness
Sepsis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Handgrip Strength as Measured by Hand Dynamometer
timeFrame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Secondary outcomes:
measure: Change in Handgrip Strength as Measured by Hand Dynamometer
timeFrame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
measure: Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
timeFrame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
measure: Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
timeFrame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
measure: Change in Quadriceps Strength as Measured by Handheld Dynamometer
timeFrame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
measure: Change in Quadriceps Strength as Measured by Handheld Dynamometer
timeFrame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dale M Needham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: