levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe - LARVOL DELTA

AAN 2025: Stable motor control seen with long-term ND0612 (Parkinson's News Today) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "The investigational liquid therapy ND0612 — an around-the-clock supply of levodopa/carbidopa infused via a pump under the skin — provides more stable motor control in people with Parkinson’s disease who experience motor fluctuations than standard immediate-release levodopa/carbidopa...That’s according to data from the randomized portion of the Phase 3 BouNDless (NCT04006210) study and its ongoing open-label extension...At the end of the 12 weeks, patients on ND0612 experienced fewer off episodes than did those on immediate-release levodopa/carbidopa (2.4 vs 3.3 per day), as well as less off time (3.76 vs. 5.2 hours). These participants had an average of about two more hours each day of on time without any dyskinesia (9.37 vs. 7.43 hours), and also transitioned between motor states less often (5.3 vs. 7.1)....Consistent with earlier findings, ND0612 was shown to be..."

P3 data • Parkinson's Disease

Mitsubishi Tanabe Pharma America to Share Latest Data on Investigational ND0612 at the 2025 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) (PRNewswire) - "Mitsubishi Tanabe Pharma America...announced that three poster presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 2025 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD), taking place April 1-5 in Vienna, Austria, and online. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD)....Presentations will highlight findings from the pivotal Phase 3 BouNDless trial (NCT04006210), including a subgroup analysis evaluating the efficacy and safety of ND0612 in different subgroups of people with PD experiencing motor fluctuations, as well as data derived from patient-reported outcomes assessing quality of life in people with PD with motor fluctuations. Additionally, one-year outcomes from the ongoing open-label extension phase of the BouNDless trial will be presented."

P3 data • Patient reported outcomes • Parkinson's Disease

Mitsubishi Tanabe Pharma America to Present Data on Investigational ND0612 at the 2024 Annual Meeting of the Parkinson Study Group (PRNewswire) - "Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of two abstracts on investigational ND0612 in Parkinson's disease (PD) at the 2024 Annual Meeting of the Parkinson Study Group (PSG), being held December 5-8 in Nashville, Tenn."

P2b data • Parkinson's Disease

Mitsubishi Tanabe Pharma America to Highlight Data on Investigational ND0612 at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (PRNewswire) - "Presentations include a range of data from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating ND0612 in people with PD experiencing motor fluctuations, utilizing data derived from patient-reported outcomes assessing quality of life and motor experiences of daily living, among other findings. Additionally, one-year outcomes from the ongoing open-label extension phase of the BouNDless trial will be presented...Additional presentations will highlight findings from analyses of Phase 2 and Phase 3 studies evaluating treatment outcomes from a 24-hour regimen of ND0612, including the characterization of infusion site reactions in patients reported as adverse events (AEs) and the characterization of dopaminergic treatment-emergent AEs reported in patients."

Clinical data • CNS Disorders • Parkinson's Disease

Mitsubishi Tanabe Pharma America to Present Latest Parkinson's Disease Research at the 10th Congress of the European Academy of Neurology (PRNewswire) - "Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced three presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 10th Congress of the European Academy of Neurology (EAN), being held in Helsinki, Finland, June 29 – July 2...Presentations include findings from subgroup analyses of the pivotal Phase 3 multi-center, randomized, double-blind double-dummy BouNDless trial (NCT04006210) evaluating the efficacy, safety and tolerability of investigational ND0612 in people with PD experiencing motor fluctuations, as well as a secondary analysis from a Phase 2 study (NCT02577523), which evaluated the onset of efficacy with ND0612 utilizing patient and clinical global ratings."

P2 data • P3 data • CNS Disorders • Parkinson's Disease

Mitsubishi Tanabe Pharma America Announces Presentations at XXIX World Congress on Parkinson’s Disease and Related Disorders (PRNewswire) - "Presentations include results from the pivotal Phase 3 multi-center, randomized, double-blind double-dummy BouNDless trial (NCT04006210) evaluating the efficacy, safety and tolerability of investigational ND0612 in people with PD experiencing motor fluctuations, in addition to three-year outcomes from the Phase 2b open-label BeyoND study (NCT02726386) evaluating the long-term safety of ND0612 in reducing OFF time in people with PD."

P2b data • P3 data • CNS Disorders • Parkinson's Disease

A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: NeuroDerm Ltd. | Phase classification: P1/2 ➔ P1

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: NeuroDerm Ltd. | Phase classification: P1/2 ➔ P1

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

NeuroDerm Announces Publication of Positive Results from Phase 3 BouNDless Trial Evaluating ND0612 in Parkinson's Disease Patients with Motor Fluctuations (PRNewswire) - P2 | N=241 | BouNDless (NCT02726386) | Sponsor: NeuroDerm Ltd. | "NeuroDerm Ltd., a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), today announced the publication of results in The Lancet Neurology from the pivotal, Phase 3 BouNDless trial (NCT04006210). Results from the trial, which evaluated the efficacy, safety and tolerability of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) – in comparison to oral immediate-release (IR) LD/CD in Parkinson's disease (PD) patients with motor fluctuations, met its primary endpoint and the first four secondary endpoints, and showed ND0612 was superior at increasing 'ON' time without troublesome dyskinesia and reducing 'OFF' time, compared to oral IR-LD/CD after 12 weeks."

P2 data • CNS Disorders • Parkinson's Disease

A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: NeuroDerm Ltd. | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations (clinicaltrials.gov) - P3 | N=381 | Active, not recruiting | Sponsor: NeuroDerm Ltd. | Trial completion date: Oct 2023 ➔ Feb 2027

Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses (PRNewswire) - "Presentations at WPC: New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5."

P2b data • P3 data • CNS Disorders • Parkinson's Disease

ND0612 vs oral immediate-release levodopa/carbidopa in patients with PD and motor fluctuations (YouTube) - "Alberto Espay, MD, MSc...describes the results of a study that compared the efficacy and safety of continuous subcutaneous ND0612, an investigational, continuous 24-hours/day subcutaneous infusion of levodopa/carbidopa, with oral immediate-release levodopa/carbidopa (IR-LD/CD) in patients with Parkinson’s disease (PD) and motor fluctuations."

Video

Quality of life with continuous subcutaneous levodopa/carbidopa infusion: exploratory findings from the ND0612 BeyoND study (IAPRD 2023) - P2 | N=214 | BeyoND (NCT02726386) | Sponsor: NeuroDerm Ltd. | "This open-label study provides preliminary support for the 12-month efficacy of treatment with ND0612 in improving quality of life and global clinical status in PwP experiencing motor fluctuations."

P2 data

Enrollment characteristics for patients entering a phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (IAPRD 2023) - P3 | N=259 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "Enrollment characteristics of patients randomized in the BouNDless trial are consistent with those observed in other clinical studies in PwP experiencing motor fluctuations."

A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=214 | Active, not recruiting | Sponsor: NeuroDerm Ltd. | Trial completion date: Oct 2023 ➔ Feb 2027

Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

ND0162 Significantly Improves ON Time in Parkinson Disease in Phase 3 BouNDless Trial (NeurologyLive) - "'In summary, 24-hour subcutaneous infusion LD/CD proved to be superior to the IR-LD/CD and that is in the order of 1.72 hours of good ON time, which as I mentioned was a combination of ON time without dyskinesia, plus ON time with nontroublesome dyskinesia,' Espay said in his presentation."

Media quote

NeuroDerm Announces Highly Positive Results from the Pivotal Phase III BouNDless Trial Evaluating ND0612 in Parkinson’s Disease Patients with Motor Fluctuations (PRNewswire) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "NeuroDerm Ltd...today announced highly positive results from the Phase III multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial....Following two sequential open-label periods to optimize oral LD/CD and ND0612, patients were randomized to either ND0612 or oral LD/CD for a 12-week DBDD period. Treatment with ND0612 demonstrated superiority over oral LD/CD, with a statistically significant difference (p<0.0001) of 1.72 hours in 'Good ON' time. The trial also demonstrated positive and clinically meaningful results for the key secondary endpoint of 'OFF' time (p<0.0001) and other secondary endpoints....Additional data will be presented at upcoming medical meetings; submissions to regulatory authorities are anticipated in the United States this year and later in the European Union."

NDA • P3 data • CNS Disorders • Parkinson's Disease

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations (clinicaltrials.gov) - P3 | N=381 | Active, not recruiting | Sponsor: NeuroDerm Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Changes in Continuous Subcutaneous Liquid levodopa/carbidopa Administration (ND0612) for patients with fluctuating Parkinson’s disease Development Plan and an Impairment Loss (Non-recurring Items) (Mitsubishi Tanabe Press Release) - "Mitsubishi Tanabe Pharma Corporation...announced today that its subsidiary, NeuroDerm Ltd...has changed the global phase 3 clinical trial plan of continuous subcutaneous liquid levodopa/carbidopa administration (ND0612) in the U.S. and Europe. Following this change, MTPC recorded an impairment loss for a part of intangible assets in the first-half of FY2020. In the global development of ND0612, due to the overlap between the expansion of COVID-19 and the important start-up period of phase 3 study; opening clinical trial sites and patient enrollment, MTPC decided to extend the development period for about 1.5 years from the plan at the time of review of 'Medium-Term Management Plan 16 -20' announced in November 2018. Under the revised ND0612 development plan, NDA/MAA are to be filed in the U.S. and Europe simultaneously in FY2023."

Enrollment status • European regulatory • NDA • Trial status • CNS Disorders • Parkinson's Disease

Beyond Phase 2b Data Indicates ND0612 Has a Positive Long-term Safety Profile for People With Parkinson’s Disease (Neuroderm) - "'At this time, ND0612 is the only investigational subcutaneous, continuous levodopa/carbidopa treatment with safety data extending beyond one year,' said Stuart Isaacson, MD, author of the BeyoND study...'This latest data reinforces a positive long-term safety and tolerability profile of ND0612, indicating it has the potential to become a convenient and safe treatment option for those struggling with motor fluctuations in Parkinson's disease.'"

Media quote

A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless). (clinicaltrials.gov) - P3; N=380; Recruiting; Sponsor: NeuroDerm Ltd.; Trial completion date: Apr 2021 ➔ Oct 2023; Trial primary completion date: Mar 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

NeuroDerm announces start of a pharmacokinetic, head-to-head comparison study of ND0612H and Duodopa (Neuroderm Press Release) - "NeuroDerm...announced that it has started a pharmacokinetic (PK) clinical study to determine the dosing of the company's lead product candidate, ND0612H...for the treatment of advanced Parkinson's Disease. This open-label, dose finding, PK study is expected to enroll a total of 24 healthy volunteers. Results of this study are expected in the second half of 2015 and, if successful, will be used to design and conduct a follow-up, definitive PK similarity study in healthy volunteers. We look forward to the results of this much anticipated Phase II clinical study. A Phase II clinical efficacy study of ND0612H is also planned to commence in the United States in the second half of 2015." 

Anticipated new P2 trial • Anticipated P2 data • Clinical protocol • Parkinson's Disease

NeuroDerm announces start of patient enrollment in phase II trial of ND0612H for advanced Parkinson’s disease (Neuroderm Press Release) - "NeuroDerm...today announced the start of patient enrollment in a first efficacy trial of ND0612H, the company’s continuously administered subcutaneous levodopa/carbidopa solution. The study is expected to enroll a total of 36 advanced Parkinson’s disease patients. The Company is proceeding on track in Europe with a head-to-head pharmacokinetic (PK) comparison study of ND0612H and DUODOPA®, the results of which are expected in Q2 2016. The Company is also planning to initiate a Phase III pivotal efficacy trial for its ND0612L treatment for patients with moderate to severe Parkinson’s disease as well as a long-term safety follow-up in the first half of 2016."

Anticipated new P3 trial • Anticipated P2 data • Anticipated target enrollment • Enrollment open • Parkinson's Disease

NeuroDerm Parkinson’s disease clinical data selected for two oral presentations at the American Academy of Neurology 68th Annual Meeting (GlobeNewswire) - "NeuroDerm Ltd...today announced that the Science Committee of the American Academy of Neurology (AAN) identified NeuroDerm’s submission for the Movement Disorders Congress, 'Stable levodopa plasma levels with ND0612 (levodopa/carbidopa for subcutaneous infusion) in Parkinson’s disease (PD) patients with motor fluctuations,' as a critical advance in the field of neuroscience and selected the data for an encore presentation at the American Academy of Neurology 68th Annual Meeting taking place April 15-21 in Vancouver, BC, Canada. Separately, pre-clinical and clinical data on the effect of continuous carbidopa on levodopa pharmacokinetics has been selected for a platform presentation."

Anticipated clinical data • Parkinson's Disease