Etrinabdione for Peripheral arterial disease

Inclusion criteria

• {"criterion_text":"- Male and female adults aged ≥ 50 to ≤ 85 years at the time of consent\n- Willing and able to provide informed consent and capable of understanding and complying with the protocol;\n- Subjects classified as critical limb ischemia (CLI) Rutherford Category 2 or 3 (moderate or severe) claudication (Appendix 1);\n- Diabetes mellitus type 2\n- Glycosylated haemoglobin (HbA1c) < 9%\n- In case of treatment for PAD, the subject is controlled on medical therapy indicated for CLI (unless there is a documented contraindication or intolerance)\n- A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause) b) Of childbearing potential and agrees to use a highly effective method of contraception consistently as defined in this protocol during the treatment period and for at least 28 days after the last dose of study treatment\n- A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for approximately 90 days after the last dose of study treatment and refrains from donating sperm during this period"}

Exclusion criteria

• {"criterion_text":"- CLI Rutherford other than Category 2 or 3\n- Planned surgical or endovascular revascularization on the index leg within the next 12 months;\n- Uncontrolled or untreated proliferative retinopathy;\n- Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening\n- Amputation at or above the talus on the index l\n- Planned major amputation within the first month after randomiz\n- On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new treatments (not standard of care) to the index leg during the trial\n- Blood clotting disorder not caused by medication (e.g., thrombophilia)\n- Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (stage 2 hypertension: Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg)\n- Evidence of moderate to severe hepatocellular dysfunction according to the Investigator\n- Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum\n- Subjects who may not be healthy enough to successfully complete all protocol requirements, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator: For example: Concurrent severe congestive heart failure (New York Heart Association Classes III and IV); Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within four weeks before screening; Coronary artery bypass grafting or percutaneous coronary intervention within one month before screening; A renal and/or carotid revascularization procedure within one month of screening; Transient ischemic attack within three months prior to screening; Deep vein thrombosis within three months prior to screening; Subjects with immunocompromised conditions, organ transplant recipients and/or subjects in need of immunosuppressive therapy; Neurological dementia (i.e., Alzheimer’s Disease)\n- Current or prior participation in a clinical trial within 3 months of first investigational product administration or 5 times the half-life of the prior investigational product, whichever is longer\n- Concomitant medication that could cause drug-interactions as defined in the appropriate section of the protocol, (Section 6.7).\n- History of malignancy with the following exceptions: basal cell carcinoma, cutaneous squamous cell carcinoma or cervical carcinoma in situ resolved > 1 year prior to screening\n- Use of cannabis products up to 28 days prior to dosing and during the study\n- Suspected hypersensitivity to cannabinoids or any of the inactive ingredients of Etrinabdione Oral Solution: corn oil and Maisine® CC\n- Confirmed diagnosis of albinism\n- Moderate or severe drug or alcohol abuse within the past year and during the study (as defined by the investigator)\n- Female participant is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 28 days after last investigational product administration. Not willing to follow the guidance for contraception methods as per protocol\n- Male participant does not agree to use acceptable contraception during the treatment period and for approximately 90 days after the last dose of study treatment or planning to donate sperm during the same period\n- Any finding that in the view of the investigator would compromise the safety of the patient or affect his/her ability to adhere to the protocol visit schedule or fulfil study requirements including self-administration"}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events (TEAEs) from baseline to the end of the study","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Changes from baseline for\tVascularization: Angio-CT","definition_or_measurement_approach":"Vascularization measured by Angio-CT; changes from baseline"}
• {"endpoint_text":"- Changes from baseline for Hemodynamic: ankle/brachial Index","definition_or_measurement_approach":"Hemodynamic assessment using ankle/brachial index; changes from baseline"}
• {"endpoint_text":"- Changes from baseline for Stenosis: doppler ultrasound","definition_or_measurement_approach":"Stenosis assessed by Doppler ultrasound; changes from baseline"}
• {"endpoint_text":"- Changes from baseline for Quality of life: VascuQoL-6 questionnaire","definition_or_measurement_approach":"Quality of life measured by VascuQoL-6 questionnaire; changes from baseline"}
• {"endpoint_text":"- Changes from baseline for Tissue oxygenation: transcutaneous oximetry (TcPO2)","definition_or_measurement_approach":"Tissue oxygenation measured by transcutaneous oximetry (TcPO2); changes from baseline"}
• {"endpoint_text":"- Changes from baseline for Etrinabdione plasma levels (pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6,12, and EOS","definition_or_measurement_approach":"Pharmacokinetic sampling: Etrinabdione plasma levels pre-dose and 3 hours post-dose at Day 1 and months 1, 3, 6, 12, and End of Study"}
• {"endpoint_text":"- Changes from baseline for selected drug and/or disease-related vascular and inflammatory biomarkers at Day 1 and months 1, 3, 6, 12, and EOS","definition_or_measurement_approach":"Selected vascular and inflammatory biomarkers measured at Day 1 and months 1, 3, 6, 12, and End of Study; changes from baseline"}
• {"endpoint_text":"- Changes from baseline for: Clinical improvement: absolute claudication time","definition_or_measurement_approach":"Clinical improvement assessed as absolute claudication time; changes from baseline"}

Spain

Earliest CTIS Part Ii Submission Date

13-02-2024

Latest Decision Or Authorization Date

18-12-2025

Processing Time Days

674

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Vivacell Biotechnology Espana S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Fundacion Para La Investigacion Biomedica De Cordoba","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}