ot available

Phase 1

• Conditions: advanced Parkinson's disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005814-31-IT
• Lead Sponsor: EURODERM LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

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).
2.Subject has completed the treatment period of study
ND0612H-006 not more than one month prior to enrolling in ND0612H-
012.
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.
2.PD diagnosis consistent with the UK Brain Bank Criteria.
3.Modified Hoehn & Yahr scale in ON state of stage =3.
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.
5.Subjects must be stable on their anti-PD medications for at
least 30 days before Day 1.
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.
7.Must have a minimum of 2 hrs of OFF time per day with
predictable early morning OFF periods as estimated by the subject.
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.
9.Mini Mental State Examination (MMSE) score = 26.
10.No clinically significant medical, psychiatric or laboratory
abnormalities which the investigator judges would be unsafe or noncompliant
in the study.
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.
12.Willing and able to administer the SC infusion alone or with
the assistance of a study partner after a screening period of up to 40
days and willing and able to comply with study requirements.
13. Subjects should have a named study partner
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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.
For Cohort 2 the following exclusion criteria apply:
1.Atypical or secondary parkinsonism.
2.Acute psychosis or hallucinations in past 6 months.
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.
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).
5.Positive serum serology for Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the
Screening visit
6.Prior neurosurgical procedure for PD, or Duodopa treatment
7.Subjects with a history of drug abuse or alcoholism within
the past 12 months.
8.Clinically significant ECG rhythm abnormalities.
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.
10. Current participation in a clinical trial with an
investigational product or past participation within the last 30 days
before Day 1.

Study & Design

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