Lu AF28996 in people with Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial to assess the safety, tolerability, and pharmacokinetics of Lu AF28996 in adults with idiopathic Parkinson's disease and visible motor fluctuations. Participants are Chinese, meet UK Brain Bank criteria for PD, and show OFF periods despite treatment, with specific Hoehn and Yahr ranges in ON and OFF states. The study excludes recent dopamine agonist use, prior PD surgeries, and other disorders that could confound results. The trial is conducted at multiple centers in Beijing and Shanghai under H. Lundbeck A/S as lead sponsor.

Why it matters

Who can join: the full rules

Key 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.

Key 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.

Where it's running

• Beijing TiantanHospital, CapitalMedical University
  Beijing, Beijing Municipality, China Recruiting
• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Fudan University - Huashan Hospital - Institute of Urology
  Shanghai Shi, Shanghai Municipality, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.