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Lu AF28996 for Parkinson's Disease

Phase 1

Recruiting

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (predose) to 24 hours postdose on day 1 to day 62

Awards & highlights

Study Summary

This triallooks at the safety, tolerability, and metabolism of a new drug for Parkinson's disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of Lu AF28996 are not listed here, common side effects in trials like this may include nausea, dizziness, sleep disturbances, headache or worsening of PD symptoms. Each person might experience different side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (predose) to 24 hours postdose on day 1 to day 62

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (predose) to 24 hours postdose on day 1 to day 62

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (predose) to 24 hours postdose on day 1 to day 62 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC(0-24h) of Lu AF28996

AUC(last) of Lu AF28996

Amount of Lu AF28996, Lu AF28995, Lu AF29308, and Lu AF29309 Excreted in Urine

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lu AF28996Experimental Treatment1 Intervention

Participants will receive ascending oral doses of Lu AF28996 OD for 14 days (Day 1 to Day 14) in all OD Cohorts 1-4 (5). On Day 15, the participant will initiate down-titration of Lu AF28996 as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days (Day 1 to Day 24), followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days (Day 1 to Day 39), followed by down-titration as per Investigator's judgement. For Part B BID Cohorts B1 and B2, participants will receive Lu AF28996 BID for up to 49 days, followed by down-titration as per Investigator's judgement. For Part C TID Cohorts C1 and C2, participants will receive Lu AF28996 for up to 49 days, followed by down-titration as per Investigator's judgement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lu AF28996

2023

Completed Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor

325 Previous Clinical Trials

77,506 Total Patients Enrolled

Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com

188 Previous Clinical Trials

58,263 Total Patients Enrolled

Media Library

Lu AF28996 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04291859 — Phase 1

Parkinson's Disease Research Study Groups: Lu AF28996

Parkinson's Disease Clinical Trial 2023: Lu AF28996 Highlights & Side Effects. Trial Name: NCT04291859 — Phase 1

Lu AF28996 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04291859 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll in this clinical trial?

"This medical trial is seeking to enrol 37 participants aged between 45 and 75 who suffer from Parkinson's disease. The necessary criteria for participation include meeting the UK PD Society Brain Bank Diagnostic Criteria, having a Modified Hoehn and Yahr Score of 4 or less in their 'OFF' state and 3 or under when 'ON', scoring higher than 25 on the Mini Mental State Examination, being responsive to levodopa therapy with at least 3 doses daily over the prior month, experiencing discernible motor fluctuations that cause disability during one week screening period (with 1.5 hours of OFF-periods in wakeful time including morning episodes)"

Answered by AI

Is the age restriction for participation in this trial limited to those over 20 years old?

"This research trial is only open for enrolment to those aged 45-75. There are 27 clinical trials specifically designed for minors and 481 studies that accept patients of more advanced ages."

Answered by AI

Is recruitment for this research project still ongoing?

"Clinicaltrials.gov indicates that this clinical trial is presently procuring participants; it was initiated on February 26th 2020 and the latest update was recorded November 4th 2022."

Answered by AI

Has Lu AF28996 been attested by the Food and Drug Administration?

"Our team at Power gave Lu AF28996 a score of 1 as it is merely in the first stage of clinical trials, and thus there is only limited supporting data for its safety and efficacy."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. The information available on clinicaltrials.gov illustrates that this medical experiment is currently recruiting participants; it was first posted in February 2020 and has been updated most recently in November 2022, with a need for 37 individuals at one testing site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Lu AF28996 in Participants With Parkinson's Disease (PD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04291859.

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