Lu AF28996 for Parkinson's Disease

Recruiting at9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: H. Lundbeck A/S

Must be taking: Levodopa

Must not be taking: Dopamine agonists

Disqualifiers: Neurological, Psychiatric, Seizure, Respiratory, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called Lu AF28996 to see if it is safe and well-tolerated in people with Parkinson's disease. The study will check how the body processes the drug and if it causes any side effects. Participants will take the drug at different frequencies during the study.

Will I have to stop taking my current medications?

Participants can continue taking certain Parkinson's medications like levodopa, monoamine oxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. However, dopamine agonists must be stopped at least 4 weeks before starting the trial and cannot be used during the study.

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for men and women with Parkinson's Disease who respond well to levodopa, have been on a stable dose for at least 4 weeks, and experience significant motor fluctuations. They should not have other major neurological issues or serious health conditions like liver problems, respiratory diseases, or immune disorders.

Inclusion Criteria

I have Parkinson's with clear motor fluctuations and can take other medications.

I have Parkinson's with clear symptoms, respond well to levodopa, and have predictable motor changes and difficult involuntary movements.

Exclusion Criteria

I have had issues with dopamine agonist drugs or experienced withdrawal symptoms from them.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive ascending oral doses of Lu AF28996 once daily for 14 days or twice daily for 24 to 39 days, followed by down-titration

2-6 weeks

Treatment Part B

Participants receive Lu AF28996 twice daily for 41 days, followed by down-titration

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lu AF28996 (Other)

Trial Overview The study is testing the safety and tolerability of a drug called Lu AF28996 in people with Parkinson's. It also looks at how the body processes this drug. Participants will be monitored to see how they react to Lu AF28996 over time.

Participant Groups

Group I: Lu AF28996 Experimental Treatment 1 Intervention

Participants in Part A will receive ascending oral doses of Lu AF28996 OD for 14 days in all OD cohorts, followed by down-titration as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days, followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days, followed by down-titration as per Investigator's judgement. Participants in Part B (Cohorts B1, B2, and B3) will receive Lu AF28996 BID for 41 days, followed by down-titration as per Investigator's judgement

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden