A multicenter, 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 (BouNDless)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511940-20-00

Acronym

ND0612-317

Enrollment

156

Registered

2024-05-17

Start date

2020-02-05

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Brief summary

The primary endpoint is the change from Baseline to the end of the DBDD Maintenance Period in the mean daily "ON" time without troublesome dyskinesia adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visit.

Detailed description

The key secondary efficacy endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean daily "OFF" time adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visits.

Interventions

DRUGPLACEBO TO ND0612. Solution for infusion

DRUGsubcutaneous use. Major ingredients: Sodium Phosphate Dibasic Anhydrous

DRUGSodium Phosphate Monobasic Dihydrate

DRUGLArginine

DRUGAscorbic Acid

DRUGND0612

DRUGIR-LD/CD

DRUGPLACEBO FOR LD/CD Capsules (white): capsules

DRUGoral use

DRUGMajor 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.

DRUGPLACEBO for LD/CD Capsules (grey):capsules

DRUGMajor 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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change from Baseline to the end of the DBDD Maintenance Period in the mean daily "ON" time without troublesome dyskinesia adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visit.	—

Secondary

Measure	Time frame
The key secondary efficacy endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean daily "OFF" time adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visits.	—

Countries

Austria, Belgium, Czechia, France, Italy, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026