--- title: "A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless)" euct_id: 2024-511940-20-00 eudra_ct_number: 2018-004156-37 phase: Bioequivalence status: Recruiting sponsor: Neuroderm Ltd. canonical_url: "https://parkinsonspathways.com/trials/eu/2024-511940-20-00" eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2024-511940-20-00" ctis_last_updated: "2026-05-20T03:32:08.360709649" source: EU Clinical Trials Information System (CTIS) --- # A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless) **EU CT Number:** [2024-511940-20-00](https://euclinicaltrials.eu/ctis-public/view/2024-511940-20-00) ## Key Facts - **Phase:** Bioequivalence - **Status:** Recruiting - **Sponsor:** Neuroderm Ltd. - **Start Date:** 2020-02-25 - **Completion Date:** 2027-05-06 - **Conditions:** Parkinson's disease - **Interventions:** PLACEBO for LD/CD Capsules (grey):capsules, oral use, Major ingredients: Carbidopa–Levodopa placebo capsule is composed of pharmacopoeia grade microcrystalline cellulose (Avicel PH-102) filled into size DB AA grey opaque capsules. It corresponds to comparator grey capsules., PLACEBO TO ND0612. Solution for infusion, subcutaneous use. Major ingredients: Sodium Phosphate Dibasic Anhydrous, Sodium Phosphate Monobasic Dihydrate, LArginine, Ascorbic Acid, ND0612, PLACEBO FOR LD/CD Capsules (white): capsules, oral use, Major ingredients: Carbidopa–Levodopa placebo tablet (White) is composed of a yellow placebo tablet and pharmacopeial grade microcrystalline cellulose Avicel PH-102) filled into size DB AA white opaque gelatin capsules., IR-LD/CD ## Member States Trial is authorized in 9 member states: Austria, Belgium, Czechia, France, Italy, Poland, Portugal, Slovakia, Spain. ## Sites (31) - Medizinische Universitaet Innsbruck, Innsbruck, Austria - Axon Clinical s.r.o., Prague 4, Czechia - Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy - Universita' Degli Studi G. D'annunzio Di Chieti, Chieti Scalo, Italy - Fondazione Santa Lucia IRCCS, Rome, Italy - Irccs San Raffaele Roma S.r.l., Cassino, Italy - Irccs San Raffaele Roma S.r.l., Rome, Italy - Azienda USL Toscana Sud Est, Grosseto, Italy - Humanitas Mirasole S.p.A., Rozzano, Italy - NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki, Lodz, Poland - Krakowska Akademia Neurologii Sp. z o.o., Cracow, Poland - Neuro-Care Sp. z o.o. sp.k., Katowice, Poland - University Hospital Bratislava, Bratislava, Slovakia - Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France - Centre Hospitalier Universitaire De Nimes, Nimes Cedex 9, France - University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France - Centre Hospitalier Regional De Marseille, Marseille, France - Centre Hospitalier Universitaire De Nice, Nice, France - Centre Hospitalier Universitaire De Nantes, Saint Herblain, France - Hospices Civils De Lyon, Bron, France - Hospital Universitari General De Catalunya, Sant Cugat Del Valles, Spain - Hospital Universitari Vall D Hebron, Barcelona, Spain - Hospital General Universitario Gregorio Maranon, Madrid, Spain - Hospital Universitario De La Princesa, Madrid, Spain - Hospital De La Santa Creu I Sant Pau, Barcelona, Spain - University Hospital Virgen Del Rocio S.L., Sevilla, Spain - Hospital General Universitario De Elche, Elche, Spain - Hospital Universitario Ramon Y Cajal, Madrid, Spain - Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes, La Louviere, Belgium - CCAB Centro Clinico Academico Braga Associacao, Braga, Portugal - CNS Saude Lda., Torres Vedras, Portugal ## Eligibility (CTIS) - **Minimum age:** 18 Years - **Sex:** ALL ``` Condition: Parkinson's disease Age groups: adults 18-64, elderly 65+ Sex: male, female Includes a vulnerable population. Period: A Screening Period (1 to 4 weeks) Subjects will be assessed for study eligibility by the Investigator at the Screening Visit(s). Screening procedures can be performed over a period of 28 days (the maximal interval between the Screening visit and the start of the IR-LD/CD Adjustment Period). Subjects and study partners will be trained on the completion of “ON/OFF” diaries to describe the subjects’ motor state. Subjects and their study partners will be trained at home by clinical trial educators (CTEs) on the administration of the SC infusion using a training pump system. The CTE will train the site staff separately on the pump before the site can start recruiting. At the end of the Screening Period, the Investigator will assess the subject’s eligibility. Blinding: BLINDED: Investigator, Patient, Analyst Carer, UNBLINDED: unblinded CRA and unblinded pharmacy person Period: Open-Label Oral IR-LD/CD Adjustment Period (4 to 6 Weeks) The eligible subjects’ oral LD formulations and catechol-O-methyl transferase (COMT) inhibitor therapy will be converted to equivalent doses of oral IR-LD/CD 100/25 mg tablets. A subject’s oral IRLD/ CD dosage regimen will then be adjusted until the regimen is optimal, according to the Investigator’s judgement. Period: Open-Label ND0612 Conversion Period (4 to 6 Weeks) Eligible subjects will receive treatment with ND0612 and adjunct grey encapsulated active oral 100/25 mg IR-LD/CD, as needed. Period: Randomized, Double-Blind, Double-Dummy Maintenance Period (12 Weeks) Subjects will be randomized in a 1:1 ratio at the Randomization visit (V13/DB D1) to 1 of 2 treatment groups: • Test Group (Group A): Active ND0612 infusion + placebo IR-LD/CD (white) + active IR-LD/CD (grey) • Control Group (Group B): Active IR-LD/CD (white) + placebo infusion + placebo IR-LD/CD (grey) Arms: - Paralel group: Subjects will be randomized in a 1:1 ratio at the Randomization visit (V13/DB D1) to 1 of 2 treatment groups: • Test Group (Group A): Active ND0612 infusion + placebo IR-LD/CD (white) + active IR-LD/CD (grey) • Control Group (Group B): Active IR-LD/CD (white) + placebo infusion + placebo IR-LD/CD (grey) Blinding: BLINDED: Investigator, Patient, Analyst, Patient Study Partner or Caregiver, UNBLINDED: unblinded CRA and unblinded pharmacy person Period: Optional Open-label Treatment Extension Period (up to 54 months) Subjects who completed the DBDD Maintenance Period will be offered the option to continue with open-label ND0612 treatment for up to 54 months in the open-label (OL) Treatment Extension Period. The end of the DBDD Maintenance Period will be defined as the first visit of the OL Treatment Extension Period. Oral LD/DDI tablets required for this period, as well as any other anti-PD medication, will not be provided by the Sponsor. Commercially available formulation/product will be prescribed per the Investigator’s discretion. Period: Safety Follow-up Period (4 Weeks) A safety follow-up visit will be performed 4 weeks after treatment completion (either after the DBDD Maintenance Period or after the OL Treatment Extension Period) or early treatment discontinuation. This follow-up visit is mandatory and is an in-person visit, except for subjects discontinuing treatment early during the Open-Label Oral IR-LD/CD Adjustment Period (for such subjects, the Investigator will determine whether the visit should be virtual or in-person). In case of an ongoing AE (including AESI), it will be followed-up until the event is resolved or until, in the opinion of the Investigator, the event is stabilized or determined to be chronic. ``` --- *Canonical: https://parkinsonspathways.com/trials/eu/2024-511940-20-00* *HTML version: https://parkinsonspathways.com/trials/eu/2024-511940-20-00* *Source data: https://euclinicaltrials.eu/ctis-public/view/2024-511940-20-00*