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

Prior treatment

• 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.

Other

• PD patients taking a single individual dose of IR LD/AAADI above 250 mg.

• 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.