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).
This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD. Subjects can continue to an optional open-label extension period for one year; To contact US site near you should go to: www.BouNDless-Study.com
- Parkinson's Disease
- Eligible Ages
- Between 30 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the UK Brain Bank Criteria.
- Modiﬁed Hoehn & Yahr score ≤3 during ON.
- Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as conﬁrmed by patient diary over 3 days.
- Taking ≥4 levodopa doses/day (≥3 doses/day of Rytary) at a total daily dose of ≥400mg.
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias.
- Previous neurosurgery for PD.
- Use of duodenal levodopa infusion (LCIG)* or apomorphine infusion.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- Previous participation in ND0612 studies.
- History of signiﬁcant skin conditions or disorders.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Blinded Site Rater, Blinded CRAs, active drugs and matching placebo are identical in their appearance.
|ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.||
|Placebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.||
UK Center for Clinical and Translational Science and nearby locations
- NCT ID
- NeuroDerm Ltd.
Study ContactYael Ullmann, BPharm
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy, parallel group 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.
This study is comprised of 6 periods:
1. a Screening Period;
2. an open-label oral IR-LD/CD Adjustment Period.
3. an open-label ND0612 Conversion Period.
4. a randomized, double-blind, double-dummy, active-controlled Maintenance Period.
5. an optional open-label Treatment Extension; and
6. a Safety Follow-up Period.