A Phase 3b open-label, randomised study of IPX203 in subjects with advanced Parkinson’s disease and motor fluctuations - ADIP study

Trial details

Who runs it

Zambon Biotech S.A.

Trial code

EU 2025-521772-57-00

Record updated

2026. június 16.

Original description

The primary objective is to investigate the efficacy of IPX203 in comparison to immediate-release (IR) levodopa (LD)/aromatic L-amino acid decarboxylase inhibitor (AAADI) regimen in improving the ON time in relation to its dosing interval and dosing frequency.Read full original descriptionShow less

The primary objective is to investigate the efficacy of IPX203 in comparison to immediate-release (IR) levodopa (LD)/aromatic L-amino acid decarboxylase inhibitor (AAADI) regimen in improving the ON time in relation to its dosing interval and dosing frequency.

Inclusion: Male or female (assigned at birth, inclusive of all gender identities) subjects age ≥40 years, inclusive, at the time of informed consent; Patients with PD consistent with the United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria, who are being treated with stable regimens of LD/AAADI since 3 months prior to screening but experiencing motor fluctuations; Patients with Hoehn and Yahr Stages 2.5 to 4 in the ON-state at screening; By history, for the 4 weeks (28 days) prior to screening, the patient experiences the following: - Daily predictable “wearing-OFF” episodes with periods of worsening motor symptoms - An average of at least 3 cumulative hours per day of OFF time, during the hours the patient is awake; Patients needed to be on a documented stable LD/AAADI and optimised dosing schedule within the last 3 months prior to screening; Taking ≥5 LD doses/day and a minimal total daily dose of 500 mg LD/AAADI. If a patient is using IR LD/AAADI or controlled-release (CR) LD/AAADI in combination with a COMT inhibitor, then the dosing frequency must be 3 to 6 times daily.

Exclusion: Patients who received any of the medications listed below or are planning to take them during participation in the clinical study: - Within 4 weeks prior to screening, any doses of a CR LD apart from a single daily bedtime dose - Any doses of Rytary or considered IPX066 or Rytary failures for reasons of efficacy or safety or considered IPX203 failure in previous clinical studies for reasons of efficacy or safety - Any additional doses of CD (eg, Lodosyn) or benserazide (eg, Serazide) - Nonselective monoamine oxidase B (MAO-B) inhibitors, apomorphine, or antidopaminergic agents, including antiemetics - Within 4 weeks prior to screening, rescue medication used to treat OFF episodes (eg, apomorphine or inhaled LD [Inbrija]) - Within 2 years prior to screening, any doses of dopamine antagonist antipsychotic agents for the purposes of psychosis or bipolar disorder; Patient had a prior neurosurgical treatment for PD (eg, deep brain stimulation surgery or neurosurgical ablation treatment procedures) or if such procedure is planned or anticipated prior to Visit 5 (Week 12) of the study; PD patient has received LD/CD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational, within the last 3 months prior to screening; PD patients taking a single individual dose of IR LD/AAADI above 250 mg.

EU CTIS 2025-521772-57-00