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Not yet recruiting NCT07513441

A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD)

Phase I Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lu AF28996.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 35 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Interventional, Open-label, Trial Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF28996 in Chinese Men and Women With Parkinson's Disease

Overview

The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.

Interventions

  • Drug Lu AF28996
    Capsule administered orally per schedule specified in the arm description.

Primary outcome measures

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 60 days]
  • Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996 [Time frame: Days 1, 21 or 31, and 41]
  • Maximum Observed Plasma Concentration (Cmax) of Lu AF28996 [Time frame: Days 1, 21 or 31, and 41]
  • Time to Reach Cmax (Tmax) of Lu AF28996 [Time frame: Days 1, 21 or 31, and 41]

Eligibility criteria

Inclusion criteria

  • The participant is Chinese, defined as having four Chinese grandparents being born in China.
  • The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD).
  • The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state.
  • The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator.

Exclusion criteria

  • The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening.
  • The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation).
  • The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance.
  • The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • West China Hospital, Sichuan University — Chengdu
  • Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07513441 · 20501A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗