ClinicalTrials.gg
Sign In
RecruitingNCT07514858DARE2Updated Sep 8, 2026

A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations

A Phase 2 interventional study of Lu AF28996 and Placebo in Parkinson's Disease, sponsored by H. Lundbeck A/S. Recruiting at 2 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by H. Lundbeck A/S · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

This trial will evaluate the effects of Lu AF28996 in adults with Parkinson's disease (PD) experiencing motor fluctuations despite optimized non-invasive symptomatic treatment. These are individuals with PD who take medications to control movement symptoms, such as slowness, stiffness, and tremor, but still experience periods of time when their medication does not adequately control their motor symptoms. Some may also experience dyskinesia (other type of involuntary movements) as a side effect of their PD medications. The main goal of the trial is to learn whether adding Lu AF28996 to participants' optimized PD medications will help extending the time they spend with their movement symptoms being well-controlled and without bothersome dyskinesia.

02

Conditions studied

  • Parkinson's Disease

Browse trials for

03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 150 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Browse H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • The participant was diagnosed with PD ≥3 years ago, with the diagnosis being established after the age of 30 years and consistent with the Movement Disorders Society (MDS) Clinical Diagnostic Criteria for "clinically established" or "clinically probable" PD.
  • The participant has a modified Hoehn and Yahr scale (mH\&Y) stage ≤3 in the ON state and ≥2 and ≤4 in the OFF state.
  • The participant reports well recognizable, consistent motor fluctuations causing significant disability per investigator's judgement over a period of ≥3 months prior to screening.
  • The participants report motor fluctuations each day as measured by OFF-time during awake hours.

Key Exclusion Criteria:

  • The participant has previously been dosed with Lu AF28996.
  • The participant has participated in a clinical trial \<30 days prior to screening.
  • The participant is pregnant, breastfeeding, intends to become pregnant, or is of and not willing to use adequate methods.
  • The participant has taken any medicinal product (IMP) \<3 months or \<5 half-lives, whichever is longer, prior to screening.
  • The participant has a Montréal Cognitive Assessment () score ≤24 (adjusted for education).
  • The participant has an atypical, secondary, or drug-induced Parkinsonism (for example, metoclopramide, flunarizine), metabolic identified neurogenetic disorders (for example, Wilson's disease), encephalitis, or Parkinson Plus syndromes or other forms of atypical Parkinsonian syndromes (for example, progressive supranuclear palsy and multiple system atrophy).
  • The participant has severe, pervasive, disabling dyskinesia which, in the setting of the present trial, may interfere with his/her safe participation in the trial (for example, threat to falling, aspiration, etc.) as judged by the investigator.
  • The participant has unpredictable motor fluctuations as evidenced by an MDS-UPDRS Part IV Item 4.5 score ≥3 at screening and/or experiences wide, unpredictable fluctuations of PD symptoms per investigator's clinical judgement.

Note: Other protocol defined inclusion and exclusion criteria may apply

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Lu AF28996

    Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23.

    Drug: Lu AF28996

  • Placebo comparator
    Placebo

    Participants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23.

    Drug: Placebo

Interventions

  • DrugLu AF28996

    Lu AF28996 will be administered orally per schedule specified in the arm description.

  • DrugPlacebo

    Placebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description.

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries

    Time frame: Baseline, Week 19

Secondary outcomes

  1. Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries

    Time frame: Baseline, Week 19

  2. Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Diary Entries in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline

    Time frame: Baseline, Week 19

  3. Change From Baseline to Week 19 in Participant's Unified Dyskinesia Rating Scale (UDysRS) Total Score in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline

    Time frame: Baseline, Week 19

  4. Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction

    Time frame: Week 19

  5. Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day

    Time frame: Week 19

  6. Participant's Achievement at Week 19 of a Reduction in Both Daily ON Time With Troublesome Dyskinesia AND in OFF time in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline

    Time frame: Week 19

  7. Change From Baseline to Week 19 in Clinical Global Impression - Severity of Illness (CGI-S) Score

    Time frame: Baseline, Week 19

  8. Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson's Disease-Rating Scale (MDS-UPDRS) Part III Score

    Time frame: Baseline, Week 19

  9. Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score

    Time frame: Baseline, Week 19

  10. Change From Baseline to Week 19 in Participant's Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Total Score

    Time frame: Baseline, Week 19

  11. Change From Baseline to Week 19 in Participant's MDS-UPDRS Part IV (B) (Questions 4.1, 4.2, 4.3, 4.4 Item Scores), and Part IV Score

    Time frame: Baseline, Week 19

  12. Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score

    Time frame: Baseline, Week 19

  13. Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score

    Time frame: Baseline, Week 19

  14. Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score

    Time frame: Baseline, Week 19

  15. Change From Baseline to Week 19 in Participant's Parkinson's Disease Questionnaire-39 (PDQ-39) Score

    Time frame: Baseline, Week 19

  16. Change From Baseline to Week 19 in Participant's EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale Score

    Time frame: Baseline, Week 19

  17. Change From Baseline to Week 19 in Daily Oral Levodopa (mg)

    Time frame: Baseline, Week 19

  18. Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED)

    Time frame: Baseline, Week 19

  19. Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LEDD)

    Time frame: Baseline, Week 19

  20. Patient Global Impression of Change (PGI-C) Score at Week 19

    Time frame: Week 19

  21. Plasma Concentrations of Lu AF28996 and Metabolites

    Time frame: Weeks 7 and 15

  22. Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Daily Entries

    Time frame: Baseline, Week 19

  23. Change From Baseline to Week 19 in Daily ON Time Without Troublesome Dyskinesia Based on Participant's Hauser Daily Entries

    Time frame: Baseline, Week 19

  24. Change From Baseline to Week 19 in Daily ON Time With Non-troublesome Dyskinesia Based on Participant's Hauser Daily Entries

    Time frame: Baseline, Week 19

  25. Change From Baseline to Week 19 in Participant's UDysRS Total Score and Combined Partial Scores of Part 1 + Part 2, Part 3 + Part 4, and Part 1 + Part 3 + Part 4, in Participants With UDysRS Total Score ≥20 at Baseline

    Time frame: Baseline, Week 19

  26. Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19

    Time frame: Week 19

  27. Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19

    Time frame: Week 19

07

Study locations

2 of 2 sites recruiting
  • Quest Research Institute - Alcanza - HyperCore - PPDS
    Farmington Hills, Michigan 48334-2973, United States
    Recruiting
  • Central Texas Neurology Consultants (CTNC)
    Round Rock, Texas 78681-3579, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Oct 2028, 26 months after the start.

Of 96 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's planned 26 months is above that.

Counting every sponsor, half of 201 studies reached it within 28 months; a quarter within 16 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2026
First posted
Apr 7, 2026
StartActual
Jul 28, 2026
Primary completionEst.
Oct 3, 2028
CompletionEst.
Oct 3, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07514858
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Jul 28, 2026
Primary completion
Oct 3, 2028 (estimated)
Completion
Oct 3, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Email contact via H. Lundbeck A/S
Contact
HQ_Medinfo@Lundbeck.com
+45 36301311
Email contact via H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lu AF28996

Other studies in this condition

Parkinson Disease →

Other studies from this sponsor

H. Lundbeck A/S →

Start the discussion