levodopa, carbidopa monohydrate for Parkinson's disease | Motor fluctuations in advanced Parkinson's disease

Inclusion criteria

• {"criterion_text":"- 1. Male or female (assigned at birth, inclusive of all gender identities) subjects age ≥40 years, inclusive, at the time of informed consent.\n- 2. 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.\n- 3. Patients with Hoehn and Yahr Stages 2.5 to 4 in the ON-state at screening.\n- 4. 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\n- 5. Patients needed to be on a documented stable LD/AAADI and optimised dosing schedule within the last 3 months prior to screening.\n- 6. 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 criteria

• {"criterion_text":"- 1. PD patients taking a single individual dose of IR LD/AAADI above 250 mg.\n- 2. 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\n- 3. 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.\n- 4. 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."}

Primary endpoints

• {"endpoint_text":"- 1. The primary endpoint is the change in good ON time at Week 12 compared to baseline for IPX203 versus IR LD/AAADI (>1 hour; ≤1 hour)","definition_or_measurement_approach":"Change in good ON time at Week 12 compared to baseline for IPX203 versus IR LD/AAADI; endpoint text includes categorical thresholds '(>1 hour; ≤1 hour)'."}

Secondary endpoints

• {"endpoint_text":"- 1. Change from baseline in OFF time at Week 12 (key secondary)","definition_or_measurement_approach":"Change from baseline in OFF time at Week 12."}
• {"endpoint_text":"- 2. Change from baseline in good ON time, ON time, change from baseline in ON time with dyskinesia, change from baseline in ON time with troublesome dyskinesia, change from baseline in ON time with non-troublesome dyskinesia, and change from baseline in ON time without dyskinesia (all derived from the Parkinson’s disease diary) up to Visit 5","definition_or_measurement_approach":"All measures derived from the Parkinson’s disease diary up to Visit 5."}
• {"endpoint_text":"- 3. Change from baseline scores for the clinical outcome assessments listed in the protocol.","definition_or_measurement_approach":"Change from baseline scores for clinical outcome assessments as enumerated in the protocol (no further detail in JSON)."}

Poland

Earliest CTIS Part Ii Submission Date

09-09-2025

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

223

Number Of Sites

11

Number Of Participants

45

Spain

Earliest CTIS Part Ii Submission Date

30-09-2025

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

199

Number Of Sites

6

Number Of Participants

23

Italy

Earliest CTIS Part Ii Submission Date

11-09-2025

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

217

Number Of Sites

5

Number Of Participants

23

Primary sponsor

Full Name

Zambon Biotech S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

codes:1,11,12,13,2,4,5,6,8

Name

Almac Clinical Services Limited

Responsibilities

code:14

Name

Biotrial Bioanalytical Services Inc.

Responsibilities

code:4

Third parties

• {"country":"Canada","full_name":"Biotrial Bioanalytical Services Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Quipment","duties_or_roles":"code:15; Site supplies/Equipment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,11,12,13,2,4,5,6,8","organisation_type":"Pharmaceutical company"}