Muscle WeaknessPhase 1/2EMILINCT02523690
Evaluating Muscle Weakness Improvement With Lorcaserin in ICU
A Phase 1/2 study testing Lorcaserin in people with Muscle Weakness and Sepsis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Sepsis
- What is being tested?
- Lorcaserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
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
- Being tested
- Lorcaserin, Placebo
- Medical subject headings
- Muscle Weakness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorcaserinDrug
10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
PlaceboDrug
Oral or enteral, single dose. Oral or enteral, single dose two days later
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm. Receives: Drug: Lorcaserin |
| Control | Placebo comparator | Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Secondary outcomes (5)
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)
Measured: 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
Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
Measured: 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
Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
Measured: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Measured: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Measured: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Slow recruitment of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale M Needham, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523690
- Sponsor's protocol ID
- IRB00072940
- Other IDs
- UL1TR001079
- Acronym
- EMILI
- Status last verified
- Dec 2019
- First submitted
- 11 Aug 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02523690
- Acronym / sponsor ID
- EMILI / IRB00072940
- Conditions
- Muscle Weakness, Sepsis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment of eligible patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: LorcaserinLorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm. |
| Control | Placebo comparator | Drug: PlaceboPlacebo will be administered as a single dose on day 1 and day 3 to participants in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorcaserin10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later | Drug | Intervention |
| PlaceboOral or enteral, single dose. Oral or enteral, single dose two days later | Drug | Control |
Primary outcome
Change in Handgrip Strength as Measured by Hand Dynamometer
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
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)
5 secondary outcomes
Change in Handgrip Strength as Measured by Hand Dynamometer
Time frame: 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
Time frame: 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
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale M Needham, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lorcaserin in people with Muscle Weakness and Sepsis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Handgrip Strength as Measured by Hand Dynamometer (time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.