A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT01725802
• Date of registration: 04/11/2012
• Prospective Registration: Yes
• Primary sponsor: NeuroDerm Ltd.
• Public title: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients
• Scientific title: A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
• Date of first enrolment: December 16, 2012
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01725802
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Israel

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- Men and women with idiopathic Parkinson's disease

- Subjects must experience motor fluctuations associated with LD/CD dosing

- Modified Hoehn and Yahr stage < 5

- Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor
therapy

- Women must be postmenopausal, surgically sterilized, or using adequate birth control.
Women of childbearing potential must have a negative pregnancy test (serum beta-HCG)
at screening.

- Subjects must be age 30 or older.

- Subjects must be willing and able to give informed consent.

Main Exclusion Criteria:

- Subjects with a clinically significant or unstable medical or surgical condition

- Subjects with clinically significant psychiatric illness.

- Pre-menopausal women, not using birth control method.

- Subjects who have taken experimental medications within 60 days prior to baseline.

- Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g.,
pallidotomy, thalamotomy, transplantation and deep brain stimulation).



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: Levodopa/carbidopa solution for SC administration

Primary Outcome(s)

Incidence and frequency of adverse events [Time Frame: up to 8 weeks]

Withdrawal rate [Time Frame: 2 days]

Secondary Outcome(s)

LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC [Time Frame: Up to 2 days]

Secondary ID(s)

ND0612/002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors