A Study to Evaluate the Efficacy and Safety of CP-012B in Participants With Parkinson’s Disease With Early Morning OFF Episodes

Trial details

Who runs it

Contera Pharma A/S

Trial code

EU 2026-526634-46-00

Record updated

2026. november 8.

Original description

To evaluate CP-012B versus placebo in mornings waking up in an ON state assessed with the eDiary after 6 weeks of treatment in participants with PD on stable daytime CD/LD treatment.Read full original descriptionShow less

A Phase 2, Multicenter, Randomized, Parallel Treatment Arms, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CP-012B in Participants with Parkinson’s Disease with Early Morning OFF Episodes

To evaluate CP-012B versus placebo in mornings waking up in an ON state assessed with the eDiary after 6 weeks of treatment in participants with PD on stable daytime CD/LD treatment.

Inclusion: 40 years of age; Female or male participant with an established diagnosis of PD as per Movement Disorder Society criteria, previously confirmed by a neurologist, and treated with a stable regimen of CD/LD or benserazide/LD; Has PD symptoms assessed by the Investigator as Hoehn and Yahr Stage 1-3 during the ON state; Is responsive to LD therapy as determined by the Investigator; Has unsatisfactory control of early morning motor symptoms based on history and Investigator assessment prior to Screening, and by waking up in an OFF state on at least 4 out of 7 mornings, as recorded in the last 7 consecutive days; Has time-to-ON ≥ 30 min on ≥ 4 of 7 mornings as recorded in a participant diary during the last 7 consecutive days; Is on a stable regimen of anti-PD medications as defined in the protocol, with no anticipated need to change anti-PD medications during the study. NOTE: Entacapone, opicapone, and controlled-release benserazide formulations are not allowed during the study; Has Montreal Cognitive Assessment (MoCA) score of ≥24 out of a possible 30 assessed at Screening and has sufficient cognitive ability to independently complete the eDiary, as determined by the Investigator; Other protocol-defined criteria apply.

Exclusion: Current or recurrent disease that, in the opinion of the Investigator, could affect study conduct, safety of the participant, or participant ability to complete the study (including, but not limited to, severe dyskinesia, hepatic disorders, renal insufficiency, congestive heart failure, conditions known to impact gastric emptying and oral absorption, and chronic wide angle glaucoma) prior to Screening; Current or relevant previous history of serious, severe, or unstable psychiatric illness, including substance abuse, dementia, major depressive disorder, clinically significant cognitive impairment, or drug induced psychosis that may interfere with reliable eDiary completion or study requirements prior to Screening; Sleep disorder or sleep patterns that, in the Investigator’s judgement, would confound the assessment of the primary endpoint, including uncontrolled sleep apnea, severe insomnia, or irregular sleep-wake patterns (eg, shift work) that prevent consistent morning wake-up assessment prior to Screening; Receiving subcutaneous LD infusion, enteral LD infusion, continuous apomorphine infusion, or deep brain stimulation therapy within 12 weeks prior to Screening; Receiving any subcutaneous or sublingual apomorphine or inhaled LD within 4 weeks prior to Screening; Use of overnight anti-PD rescue medication; Atypical or secondary parkinsonism; Unable to reliably identify ON versus OFF motor state at wake-up, based on Screening eDiary training/qualification, or inability to understand the study definitions of ON and OFF in the opinion of the Investigator; Other protocol-defined criteria apply.

EU CTIS 2026-526634-46-00