A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease

Phase 2

Active, not recruiting

• Conditions: Parkinson's Disease
• Interventions: Drug: ND0612

• Registration Number: NCT02726386
• Lead Sponsor: NeuroDerm Ltd.

Brief Summary

This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease (PD).

Detailed Description

This is a multi-center, international, open-label, safety study of ND0612, a solution of LD/CD delivered via a pump system as a continuous SC infusion in subjects with advanced PD. Two cohorts of subjects are candidates for this study: subjects who completed treatment in study ND0612H-006 within one month prior to enrollment (Cohort 1) and ND0612 naïve subjects or subjects who completed treatment in a ND0612 clinical study more than one month before screening (Cohort 2). After screening procedures and confirmation of the inclusion/exclusion criteria, subjects and their study partners will be trained and assisted at their homes during the first week of treatment on the proper operation of the pump system. One mandatory home visit will be performed during the first week and then on a monthly basis during 12-months of treatment. Subjects will return for in-clinic visits at Week 1 and at Months 1, 2, 3, 4, 6, 9, and 12 for assessment of safety and efficacy variables. Subjects will be allowed to continue with study treatment for an optional treatment extension period of up to Month 102 and the clinic visits will be performed every 3 months to assess subject long-term safety. Safety follow-up visits will occur 1, 2, and 3 months after the last SC infusion of ND0612 or after early termination.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-01
• Study Start: 2016-05-04
• Primary Completion: 2019-09-09
• Results First Submitted: 2023-03-16
• Results First Submitted QC: 2023-05-02
• Results First Posted: 2023-05-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24-hour dosing regimen	ND0612	Continuous SC infusion over 24 hours: fixed day rate of up to 0.64 mL/h for 18 hours, followed by a night rate of 0.08 mL/h for 6 hours to deliver a total daily dose of up to 720/90 mg of levodopa/carbidopa. All patients who had been previously assigned to the 24-hour group in the prior study continued on this dosing regimen; patients who had previously been assigned to the 14-hour daytime regimen were switched to the 24-hour regimen.
16-hour dosing regimen	ND0612	Continuous SC infusion for over 16 hours: fixed rate of 0.75 mL/h to deliver a total infusion dose of 720/90 mg of levodopa/carbidopa over 16 hours. The device is removed at night and patients in this group also receive a morning oral dose of levodopa/carbidopa upon awakening.

Primary Outcome Measures

Name	Time	Method
Adverse Events (Long-term Safety)	Baseline to Month 12	Long-term safety (systemic and local) assessment will be based on adverse events (AEs), with a focus on adverse events of special interest (AESI), i.e., infusion site reactions, cases of hypersensitivity, polyneuropathy.
Percentages of Subjects Who Complete the 12-month Treatment Period or Discontinue Due to AE (Tolerability)	Baseline to Month 12	Tolerability will be assessed based on the percentage of subjects that complete the 12-month treatment period of the study and the percentage of subjects who discontinue from the 12-month treatment period due to an AE.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (Long-term Safety)	Month 12 to Month 102	Long-term safety (systemic and local) and tolerability will be based on AEs, with a focus on AESI, i.e., infusion site reactions, cases of hypersensitivity, polyneuropathy.

Trial Locations

Locations (56)

Parkinsons Disease Treatment Center of Southwest Florida; 🇺🇸 Port Charlotte, Florida, United States

IRCCS San Raffaele Pisana; 🇮🇹 Rome, Italy

Henry Ford Hospital; 🇺🇸 West Bloomfield, Michigan, United States

Infinity Clinical Research, LLC; 🇺🇸 Sunrise, Florida, United States

AOU Pisa; 🇮🇹 Pisa, Italy

Universitaets-und Rehabilitationskliniken Ulm; 🇩🇪 Ulm, Germany

Hadassah Medical Center, Ein-Kerem Campus; 🇮🇱 Jerusalem, Israel

Hopital Neurologique Pierre Wertheimer; 🇫🇷 BRON Cedex, France

The Parkinsons and Movement Disorder Institute; 🇺🇸 Fountain Valley, California, United States

Centrum Medyczne PLEJADY; 🇵🇱 Kraków, Poland

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand Cedex 1, France

Hopital Roger Salengro; 🇫🇷 Lille Cedex, France

Barzilai MC; 🇮🇱 Ashkelon, Israel

The Movement Disorder Clinic of Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

University of Maryland, Neurology; 🇺🇸 Baltimore, Maryland, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Klinikum-Bremerhaven Reinkenheide; 🇩🇪 Bremerhaven, Germany

Synergy Trials; 🇺🇸 Richmond, Virginia, United States

Xenoscience; 🇺🇸 Phoenix, Arizona, United States

Parkinson's Disease and Movement Disorder Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Clinical Trials Inc.; 🇺🇸 Little Rock, Arkansas, United States

Neuro Pain Medical Center; 🇺🇸 Fresno, California, United States

Neurology Associates, PA; 🇺🇸 Maitland, Florida, United States

Suncoast Neuroscience Associates; 🇺🇸 Saint Petersburg, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Pyramid Clinical Research; 🇺🇸 Somerset, New Jersey, United States

QUEST Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

Unity Point Health; 🇺🇸 Des Moines, Iowa, United States

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

NEUROHK, s.r.o.; 🇨🇿 Chocen, Czechia

Hopital de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier d'Aix; 🇫🇷 Aix-en-Provence, France

Clintrial s.r.o.; 🇨🇿 Praha, Czechia

Vestra Clinics, s.r.o.; 🇨🇿 Rychnov nad Kněžnou, Czechia

CHU d'Amiens, Hopital Sud; 🇫🇷 Amiens Cedex 1, France

Kliniken Beelitz GmbH; 🇩🇪 Beelitz-Heilstätten, Germany

CHU de Poitiers; 🇫🇷 Poitiers, France

St. Josefs Hospital; 🇩🇪 Bochum, Germany

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden; 🇩🇪 Dresden, Germany

University Foundation; 🇮🇹 Chieti, Italy

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

IRCCS Hospital San Camillo Venice; 🇮🇹 Venice, Italy

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Klinik Haag; 🇩🇪 Haag in Oberbayern, Germany

Rocky Mountain Movement Disorders Center; 🇺🇸 Englewood, Colorado, United States

University of Florida Health at Jacksonville; 🇺🇸 Jacksonville, Florida, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Sentara Neuroscience Institute; 🇺🇸 Virginia Beach, Virginia, United States

Premier Research; 🇺🇸 Spokane, Washington, United States

Krakowska Akademia Neurologii Sp. z o.o.; 🇵🇱 Kraków, Poland

Indywidualna Praktyka Lekarska prof. dr hab; 🇵🇱 Lublin, Poland

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

USF Health Parkinson's Disease and Movement Disorders; 🇺🇸 Tampa, Florida, United States