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
NCT ID: NCT02782481
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-08-31
2018-10-15
Brief Summary
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Detailed Description
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The study will investigate the efficacy, safety and tolerability of continuous SC infusion (16 weeks) of ND0612 compared with placebo infusion. The treatment period will be comprised of a 4-week adjustment period during which time the ND0612 infusion dose will remain constant and the oral LD/DDI dose can be decreased or increased back up to the Baseline levels. All other anti-PD treatments must remain constant. During the maintenance period (Weeks 5 to 16) all anti-PD medication including the ND0612/placebo should remain constant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ND0612 High dose (Levodopa/Carbidopa solution)
High dose ND0612 SC infusion over 24 h
ND0612
ND0612 Low dose (Levodopa/Carbidopa solution)
Low dose ND0612 SC infusion over 24 h
ND0612
Placebo
Placebo SC infusion over 24 h
Placebo
Interventions
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ND0612
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
30 Years
80 Years
ALL
No
Sponsors
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NeuroDerm Ltd.
INDUSTRY
Responsible Party
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Locations
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Haddasah Ein Kerem Medical center
Jerusalem, , Israel
Countries
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Other Identifiers
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ND0612L-007
Identifier Type: -
Identifier Source: org_study_id