Lu AF28996 for Parkinson's Disease

Not currently recruiting at 18 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lundbeck A/S

Must be taking: Levodopa

Must not be taking: Dopamine agonists

Disqualifiers: Neurological, Psychiatric, Seizure, Respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new drug, Lu AF28996, for individuals with Parkinson's disease. Researchers aim to assess how the body processes this medication and its potential to manage symptoms. Participants will take the drug in varying dosages over several weeks. The trial suits those with Parkinson's who experience noticeable motor fluctuations and are on a stable dose of levodopa. Individuals experiencing daily "off" periods, when medication is less effective, and who respond well to levodopa may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

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.

Is there any evidence suggesting that Lu AF28996 is likely to be safe for humans?

Research has shown that Lu AF28996 is undergoing safety testing in people with Parkinson's disease. While detailed safety information remains unavailable, its presence in early trials indicates that researchers are carefully assessing its effects. This phase helps them identify any side effects and understand how the body processes the drug. Lu AF28996 is not yet approved for any use, so safety information continues to be collected. Participants in these studies receive close monitoring to ensure their safety and manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Researchers are excited about Lu AF28996 for Parkinson's disease because it offers a potentially novel approach compared to standard treatments like Levodopa and dopamine agonists. While most current therapies focus on replacing or mimicking dopamine, Lu AF28996 is being explored for its unique mechanism that may target different pathways involved in the disease. This could mean improved management of symptoms and possibly fewer side effects, which is an exciting development for both patients and clinicians.

What evidence suggests that Lu AF28996 might be an effective treatment for Parkinson's disease?

Research has shown that Lu AF28996 acts like dopamine, a brain chemical that helps control movement and coordination. People with Parkinson's disease often have low dopamine levels. Early results suggest that Lu AF28996, which participants in this trial will receive, might help manage Parkinson's symptoms. Although limited data from human studies exist, the mechanism of Lu AF28996 offers hope for its effectiveness. Previous studies on similar treatments have shown promise in improving movement and reducing symptoms. Overall, Lu AF28996 has potential, but more research is needed to confirm its efficacy. ^{1 4 5 6 7}

Who Is on the Research Team?

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lu AF28996

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.

How Is the Trial Designed?

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

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/490575

Lu AF28996 in Participants With Parkinson's Disease (PD) 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06004180

A Trial Investigating Lu AF28996 in Adult Japanese ... This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with Parkinson's disease (PD). The main goals of the trial are to learn ...

3. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/52830/pdf

Interventional, open-label, exploratory study, investigating ... Lu AF28996 mimics the activity of dopamine and can therefore potentially be used for the treatment of Parkinson*s disease. Study objective. Main ...

4. ctv.veeva.com ctv.veeva.com/study/a-trial-investigating-lu-af28996-in-adult-japanese-participants-with-parkinsons-disease-pd

A Trial Investigating Lu AF28996 in Adult Japanese ... This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with Parkinson's disease (PD).

5. withpower.com withpower.com/trial/phase-1-parkinson-disease-1-2020-08277

Lu AF28996 for Parkinson's Disease · Info for Participants 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04291859

Lu AF28996 in Participants With Parkinson's Disease (PD) 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 ...

7. synapse.patsnap.com synapse.patsnap.com/drug/523c51d12e6d40098c2807108b93baa9

Lu-AF28996 - Drug Targets, Indications, Patents Investigating the safety, tolerability, pharmacokinetics and pharmacodynamic properties of Lu AF28996 in Japanese men and women with Parkinson's disease.