A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO

euroDerm Ltd.0 个研究点目标入组 240 人开始时间: 2017年9月5日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Male and female PD subjects of any race aged at least 30 years
•2. PD diagnosis consistent with the UK Brain Bank Criteria.
•3. Modified Hoehn & Yahr scale in ON” state =3
•4. Subjects must experience motor fluctuations and experience an average of at least 2 hours daily in the OFF” state
•5. Subject treatment is stable with at least 4 doses/day of LD/DDI (or at least 3 doses/day of Rytary) and according to the Investigator judgment, motor fluctuations cannot be further improved by adjusting oral LD medications.
•6. Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1).
•7. Subject and/or study partner must demonstrate ability to keep accurate diary entries of PD symptoms (ON-OFF” diaries) with at least 75% concordance with the study rater by the end of the diary training session at the end of the screening period.
•8. Mini Mental State Examination (MMSE) score > 24.
•9. 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 192

•1. Atypical or secondary parkinsonism.
•2. Acute psychosis or troublesome hallucinations in past 6 months.
•3. Subjects with a clinically significant or unstable medical, surgical, psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
•4. Clinically significant ECG abnormalities.
•5. Renal or liver dysfunction that may alter drug metabolism including Screening visit serum levels of creatinine >1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x upper limit of normal (ULN), total bilirubin >2.5 mg/dL.
•6. Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit
•7. 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
•8. Use of prohibited medications as per protocol
•9. Subjects who have previously undergone treatment for PD with a neurosurgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures), Duodopa/Duopa, or continuous dopaminergic or apomorphine infusion.
•10. Subjects with skin lesions that might interfere with a subcutaneous treatment regimen.

发起方

euroDerm Ltd.