A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02782481
• Date of registration: 22/05/2016
• Prospective Registration: Yes
• Primary sponsor: NeuroDerm Ltd.
• Public title: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
• Date of first enrolment: August 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02782481
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Israel

Key inclusion & exclusion criteria

Key Inclusion Criteria:

1. Male and female PD subjects of any race aged 30-80 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. Taking at least 4 doses/day of IR LD/DDI (or at least 3 doses/day of Rytary) and
taking, or having taken therapeutic doses of at least 2 other classes of anti-PD
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 >26.

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.

Key Exclusion Criteria:

1. Atypical or secondary parkinsonism.

2. Psychosis or 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 >1.3 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 Hepatitits B Virus (HBV), Hepatitits 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: ND0612

Drug: Placebo

Primary Outcome(s)

The change from Baseline to Week 16 in the mean percentage of "OFF" time during waking hours, based on patient's home diary assessments [Time Frame: baseline to week 16]

Secondary ID(s)

ND0612L-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors