ICU Acquired WeaknessPhase 2NCT04430283
Evaluation of FDY-5301 in Major Trauma Patients in ICU
A Phase 2 study testing FDY-5301 in people with ICU Acquired Weakness, run by Faraday Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- FDY-5301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Sep 2021to 4 Mar 2022
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Major trauma defined as:
- thoracic and/or abdominal and/or pelvic injury
- necessitating admission to ICU with ventilation anticipated for at least 24 hrs
- hemorrhagic shock defined as systolic blood pressure (SBP) <90 mmHG requiring blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or within one hour after hospital arrival
- IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury)
Who cannot join
- Likely to die within 48 hrs from time of screening
- Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example:
- Computed tomography imaging showing evidence of traumatic brain injury (TBI), combined with best representative Glasgow Coma Score (GCS) Motor Score of ≤4 at approximately 24 hrs post injury
- Evidence of nonreversible spinal cord injury
- Bilateral femoral fractures
- Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
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- Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
- Known allergy to iodine
- Chronic renal disease requiring dialysis
- Body mass index (BMI) >40 kg/m2 or <16 kg/m2
- Body weight (BW) >140 kg (or >309 lb)
- History or presence of debilitating neurologic or other neuromuscular disease (e.g., spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of randomization
- Current metastatic cancer
- Solid organ transplant recipient
- Evidence of pre-existing sarcopenia defined as having a pre-trauma Clinical Frailty Score (CFS) of ≥5 or based on clinical judgement (e.g. frail by appearance, cachexia, etc.)
- Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6 months of randomization (inhaled and topical steroids are allowed)
- Use of investigational drugs or devices within 30 days of randomization
- Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital, Harvard Medical School
Boston, Massachusetts, 02114
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Florida Health Shands Hospital
Gainesville, Florida, 32610
Harborview
Seattle, Washington, 98104
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
Read the detailed description
The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to placebo in trauma ICU patients at risk of ICUAW.
Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may help prevent or treat muscle weakness and organ dysfunction in major trauma patients.
Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation in each group, the randomization will be stratified by the presence or absence of any pelvic or lower limb fractures.
All subjects who satisfy the eligibility criteria will be randomly allocated to one of three treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo).
All subjects will be followed for 6 months.
This study will be conducted globally.
- Conditions
- ICU Acquired Weakness
- Being tested
- FDY-5301, Placebo
- Keywords
- ICU acquired weakness, PICS, SIRS, Muscle wasting and weakness, muscle function, quality of life
- Medical subject headings
- Muscular Atrophy, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDY-5301Drug
FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.
PlaceboOther
Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.
| Study group | Role | What they receive |
|---|---|---|
| FDY-5301 Low Dose (1 mg/kg) | Experimental | FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Receives: Drug: FDY-5301 |
| FDY-5301 High Dose (2 mg/kg) | Experimental | FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Receives: Drug: FDY-5301 |
| Placebo | Placebo comparator | Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
Other Names:
Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chelsea Critical Care Physical Assessment Tool
Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.
Measured: Day 10 or hospital discharge, whichever occurs first.
Organ Dysfunction Total Time to Recovery
Organ dysfunction total time to recovery (TTR) until Day 28
Measured: Day 28 or hospital discharge, whichever occurs first.
Secondary outcomes (3)
Medical Research Council Sum Score
Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.
Measured: Day 28, or hospital discharge, whichever occurs first
Sequential Organ Failure Assessment Score
The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.
Measured: ICU hospital stay until Day 28 or ICU discharge if earlier
Overall Survival at Day 28
Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start20 Sep 2021
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Why it stopped: The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.
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 ICU Acquired WeaknessStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faraday Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430283
- Sponsor's protocol ID
- FDY-5301-203
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2020
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.
- ClinicalTrials.gov ID
- NCT04430283
- Acronym / sponsor ID
- FDY-5301-203
- Conditions
- ICU Acquired Weakness
- Keywords
- ICU acquired weakness, PICS, SIRS, Muscle wasting and weakness, muscle function, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Faraday Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
Detailed description
The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to placebo in trauma ICU patients at risk of ICUAW.
Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may help prevent or treat muscle weakness and organ dysfunction in major trauma patients.
Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation in each group, the randomization will be stratified by the presence or absence of any pelvic or lower limb fractures.
All subjects who satisfy the eligibility criteria will be randomly allocated to one of three treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo).
All subjects will be followed for 6 months.
This study will be conducted globally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.
| Arm | Type | Receives |
|---|---|---|
| FDY-5301 Low Dose (1 mg/kg) | Experimental | Drug: FDY-5301FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. |
| FDY-5301 High Dose (2 mg/kg) | Experimental | Drug: FDY-5301FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Other Names: Saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years
- Major trauma defined as:
- IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury)
Key exclusion criteria (18 listed)
- Likely to die within 48 hrs from time of screening
- Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example:
- Evidence of nonreversible spinal cord injury
- Bilateral femoral fractures
- Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
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 |
|---|---|---|
| FDY-5301FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml. | Drug | FDY-5301 High Dose (2 mg/kg), FDY-5301 Low Dose (1 mg/kg) |
| PlaceboPlacebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline. | Other | Placebo |
Primary outcome
Chelsea Critical Care Physical Assessment Tool
Time frame: Day 10 or hospital discharge, whichever occurs first.
Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.
Organ Dysfunction Total Time to Recovery
Time frame: Day 28 or hospital discharge, whichever occurs first.
Organ dysfunction total time to recovery (TTR) until Day 28
3 secondary outcomes
Medical Research Council Sum Score
Time frame: Day 28, or hospital discharge, whichever occurs first
Sequential Organ Failure Assessment Score
Time frame: ICU hospital stay until Day 28 or ICU discharge if earlier
Overall Survival at Day 28
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDY-5301 in people with ICU Acquired Weakness, run by Faraday Pharmaceuticals, Inc. at 5 sites 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 6 inclusion and 18 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 phase mean?
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 Jun 2023). 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?
Chelsea Critical Care Physical Assessment Tool (time frame: Day 10 or hospital discharge, whichever occurs first.). The study lists 2 primary outcomes in all. 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 Jun 2023.