A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson’s Disease (BeyoND)

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-513548-27-00
• Lead Sponsor: euroderm Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

To be eligible for study entry subjects in Cohort 1 (previously completed the treatment period in protocol ND0612H-006 within one month prior to enrolling to ND0612H-012) must satisfy all of the following criteria: 1.Subject is able to, and has signed an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF)., Cohort 2: 6.Subjects may have had prior exposure to SC apomorphine injections/infusion but must have stopped continuous apomorphine administration at least 4 weeks before the screening visit. Treatment with apomorphine is prohibited during the entire ND0612 treatment period., Cohort 1: 2.Subject has completed the treatment period of study ND0612H-006 not more than one month prior to enrolling in ND0612H-012., Cohort 1: 3.Willing and able to administer the SC infusion alone or with the assistance of a study partner and able to comply with the study specific procedures., To be eligible for study entry subjects in Cohort 2 (ND0612 naïve subjects and subjects who completed treatment in a ND0612 clinical study more than one month before screening) must satisfy all of the following criteria: 1.Male and female PD subjects of any race aged at least 30 years who sign an IRB/EC-approved ICF., Cohort 2: 2.PD diagnosis consistent with the UK Brain Bank Criteria., Cohort 2: 3.Modified Hoehn & Yahr scale in ON” state of stage =3., Cohort 2: 4.Taking at least 4 doses/day of LD/DDI (or at least 3 doses/day of Rytary) and taking, or have attempted to take, at least one other PD treatment for at least 30 days., Cohort 2: 5.Subjects must be stable on their anti-PD medications for at least 30 days before Day 1., Cohort 2: 7.Must have a minimum of 2 hrs of OFF” time per day with predictable early morning OFF” periods as estimated by the subject., Cohort 2: 8.Must have predictable and well defined early morning OFF” periods with a good response to LD for treatment of the early morning OFF” in the judgement of the investigator., Cohort 2: 9.Mini Mental State Examination (MMSE) score = 26., Cohort 2: 10.No clinically significant medical, psychiatric or laboratory abnormalities which the investigator judges would be unsafe or noncompliant in the study., Cohort 2: 11.Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (defined as cessation of menses for at least 1 year), or willing to practice a highly effective method of contraception. All female participants must be nonlactating and non-pregnant and have a negative urine pregnancy test at Screening and at Baseline. Female subjects of childbearing potential must practice a highly effective method of contraception (e.g., oral contraceptives, intrauterine devices, partner with vasectomy), 1 month before enrollment, for the duration of the study, and 3 months after the last dose of study drug. Alternatively, true abstinence is acceptable when it is in line with the subject´s preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above., Cohort 2: 12.Willing and able to administer the SC infusion alone or with the assistance of a study partner after a screening period up to 40 days and willing and able to comply with study requirements., Cohort 2: 13. Subjects should have a named study partner.

Exclusion Criteria

Subjects in Cohort 1 and Cohort 2 will be excluded from the study if one or more of the following criteria listed below are applicable. 1.Previously unable to tolerate ND0612 and/or have experienced intolerable adverse drug reactions associated with its use, regardless of the dosing regimen administered., Cohort 2: 9. Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.3 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL., Cohort 2: 10. Current participation in a clinical trial with an investigational product or past participation within the last 30 days before Day 1., For Cohort 2 the following exclusion criteria apply: 1.Atypical or secondary parkinsonism., Cohort 2: 2.Acute psychosis or hallucinations in past 6 months., Cohort 2: 3.Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study., Cohort 2: 4. Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated treatment., Cohort 2: 5. Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit., Cohort 2: 6. Prior neurosurgical procedure for PD, or Duodopa treatment, Cohort 2: 7. Subjects with a history of drug abuse or alcoholism within the past 12 months., Cohort 2: 8. Clinically significant ECG rhythm abnormalities.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the long term safety (systemic and local) and tolerability of continuous SC infusion of ND0612.;Secondary Objective: 1. To further assess the safety and tolerability of ND0612 including suicidality, excessive daytime sleepiness, vital signs, laboratory tests and electrocardiogram data. 2. To assess the long-term safety (systemic and local) and tolerability of continuous SC infusion of ND0612.;Primary end point(s): Safety endpoint assessing the long-term safety (systemic and local) and tolerability of continuous SC infusion of ND0612 throughout the 12-month treatment period.