A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension
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ClinicalTrials.gov Identifier: NCT03462043 |
Recruitment Status :
Withdrawn
(Decision to change the study design)
First Posted : March 12, 2018
Last Update Posted : November 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson | Combination Product: ND0612 Combination Product: CLES | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pivotal, Open-Label, Randomized, Crossover Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension |
Actual Study Start Date : | April 10, 2018 |
Estimated Primary Completion Date : | November 20, 2018 |
Estimated Study Completion Date : | December 30, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sequence A |
Combination Product: ND0612
s.c. infused Combination Product: CLES Carbidopa-Levodopa Enteral Suspension. |
Active Comparator: Sequence B |
Combination Product: ND0612
s.c. infused Combination Product: CLES Carbidopa-Levodopa Enteral Suspension. |
Active Comparator: Sequence C |
Combination Product: ND0612
s.c. infused Combination Product: CLES Carbidopa-Levodopa Enteral Suspension. |
Active Comparator: Sequence D |
Combination Product: ND0612
s.c. infused Combination Product: CLES Carbidopa-Levodopa Enteral Suspension. |
- Bioavailability [ Time Frame: 6-7 days ]To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Advanced PD treated with LD/CD at a dose of at least 800 mg LD
- Female patients must have a negative pregnancy test at screening and at admission.
- Patients must have a body mass index (BMI) within the range of 18.5 - 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
- Must be willing and able to communicate and participate in the whole study.
- Must provide written informed consent.
- Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
- Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration
Exclusion Criteria:
- Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
- Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
- Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
- Clinically significant electrocardiogram (ECG) rhythm abnormalities.
- Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
- Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
- Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
- use of any medication from the prohibited concomitant therapies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462043
Italy | |
91601 | |
Roma, Italy, 00163 |
Study Director: | Osnat Ehrman | NeuroDerm Ltd. |
Responsible Party: | NeuroDerm Ltd. |
ClinicalTrials.gov Identifier: | NCT03462043 |
Other Study ID Numbers: |
ND0612-315 |
First Posted: | March 12, 2018 Key Record Dates |
Last Update Posted: | November 23, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |