Is NCT05211986 recruiting in Orange, CA?

Yes, NCT05211986 is currently recruiting participants at its Orange, CA location. This muscle atrophy clinical trial is actively enrolling qualified participants.

How do I join the muscle atrophy clinical trial in Orange?

To join this clinical trial in Orange, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orange clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Muscle Atrophy Clinical Trial in Orange, CA

Who Can Participate

Inclusion Criteria

Has moderate KOA (defined as Kellgren-Lawrence \[KL\] grade 2 to 3) on affected limb

Has quadriceps weakness (\<7.5N/kg)

Can ambulate \>50 feet unassisted

This criteria deleted with protocol amendment 6

Has a body mass index (BMI) of \<40kg/m2

A male must agree to use contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.

A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential (WOCBP). OR

A WOCBP who agrees to follow the protocol's contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.

Female has a negative pregnancy test result at screening and prior to investigational medicinal product (IMP) administration

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Willing and able to comply with all study requirements, according to the judgment of the Investigator

Has discontinued systemic oral or intravenous steroid use for 6 months prior to Screening

Has vital sign measurements within the following ranges at Baseline (predose at Visit 2): heart rate \>50 and \<100 bpm, systolic blood pressure \>100 and \<170 mmHg, diastolic blood pressure \>50 and \<90 mmHg, and blood oxygenation (by pulse-oximetry) \>95%

Participant has undergone and failed at least 1 3-month or longer treatment regimen (ie, activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy) within a 2-year period prior to the Screening visit.

Study participant is able to speak, read, and understand English, in order to understand the nature of this study.

Exclusion Criteria

Severe KOA (defined as KL grade \>3) on contralateral limb

Has had prior total knee arthroplasty

Has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol

Has current or past history of malignancy (5y) excluding nonmelanoma skin cancer

Has neurological, vascular, or cardiac condition that limit function, or, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study

Has uncontrolled comorbidities including diabetes (hemoglobin A1c level \>7.0%), Hypertension (resting heart rate \>100 bpm, systolic blood pressure \>170 mmHg, or diastolic blood pressure \>90 mmHg), cardiovascular disease, asthma, or COPD.

Is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (HIV-1/2Ab). Patients with a negative RNA test for HCV are acceptable.

Is taking a prohibited medication or has taken a prohibited medication (narcotic pain medication, local anti-inflammatory, other investigational drugs)

Participant has had a change in medication to manage comorbid condition(s) (including diabestes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit.

Participant received intra-articular cortisone or viscosupplementation product(eg, Synvisc®) injections within 3 months prior to the first dose of IMP.

Has had administration of a live, attenuated vaccine within 28 days of starting study treatment or anticipation that such vaccine will be required during the study Prior/concurrent clinical study experience

Has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

This criteria was deleted with protocol amendment 6

Has current or past history (10y) of smoking

Has a history of chronic alcohol or drug abuse within the previous 3 months

Participant is currently using a systemic oral or intravenous steroid regimen (eg, for asthma or other chronic respiratory condition) or brief course of systemic pulse steroid administration (eg, for flare up of nonarthritic condition or COVID-19).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orange?

Yes, this clinical trial (NCT05211986) has an active research site in Orange, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Muscle Atrophy Treatment Options in Orange, CA

If you're searching for muscle atrophy treatment options in Orange, CA, this clinical trial (NCT05211986) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orange research site is actively enrolling participants for this clinical trial. You'll receive care from experienced muscle atrophy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all muscle atrophy clinical trials near you to find additional studies recruiting in your area.

Muscle Atrophy Clinical Trial in Orange, CA

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About This Muscle Atrophy Study in Orange