Parkinson's DiseasePhase 2DARE2NCT07514858
A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations
A Phase 2 study testing Lu AF28996 in people with Parkinson's Disease, run by H. Lundbeck A/S at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Lu AF28996
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2026to 3 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 child-bearing potential and not willing to use adequate contraceptive methods.
- The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives, whichever is longer, prior to screening.
- The participant has a Montréal Cognitive Assessment (MoCA) 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).
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Quest Research Institute - Alcanza - HyperCore - PPDS
Farmington Hills, Michigan, 48334-2973
- Recruiting
Central Texas Neurology Consultants (CTNC)
Round Rock, Texas, 78681-3579
About this study
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Trial of Lu AF28996 in Adults With Parkinson's Disease Experiencing Motor Fluctuations
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.
- Conditions
- Parkinson's Disease
- Being tested
- Lu AF28996, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF28996Drug
Lu AF28996 will be administered orally per schedule specified in the arm description.
PlaceboDrug
Placebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Lu AF28996 | Experimental | Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23. Receives: Drug: Lu AF28996 |
| Placebo | Placebo comparator | Participants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries
Measured: Baseline, Week 19
Secondary outcomes (27)
Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries
Measured: Baseline, Week 19
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
Measured: Baseline, Week 19
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
Measured: Baseline, Week 19
Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction
Measured: Week 19
Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day
Measured: Week 19
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
Measured: Week 19
Change From Baseline to Week 19 in Clinical Global Impression - Severity of Illness (CGI-S) Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson's Disease-Rating Scale (MDS-UPDRS) Part III Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Total Score
Measured: Baseline, Week 19
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
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Participant's EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale Score
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Daily Oral Levodopa (mg)
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED)
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LEDD)
Measured: Baseline, Week 19
Patient Global Impression of Change (PGI-C) Score at Week 19
Measured: Week 19
Plasma Concentrations of Lu AF28996 and Metabolites
Measured: Weeks 7 and 15
Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Daily Entries
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Daily ON Time Without Troublesome Dyskinesia Based on Participant's Hauser Daily Entries
Measured: Baseline, Week 19
Change From Baseline to Week 19 in Daily ON Time With Non-troublesome Dyskinesia Based on Participant's Hauser Daily Entries
Measured: Baseline, Week 19
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
Measured: Baseline, Week 19
Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19
Measured: Week 19
Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19
Measured: Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start28 Jul 2026
- Primary completion3 Oct 2028 (estimated)
- Study completion3 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514858
- Sponsor's protocol ID
- 20309A
- Acronym
- DARE2
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Trial of Lu AF28996 in Adults With Parkinson's Disease Experiencing Motor Fluctuations
- ClinicalTrials.gov ID
- NCT07514858
- Acronym / sponsor ID
- DARE2 / 20309A
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 3 Oct 2028 (estimated)
- Study completion
- 3 Oct 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AF28996 | Experimental | Drug: Lu AF28996Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (9 listed)
- 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 child-bearing potential and not willing to use adequate contraceptive methods.
- The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives, whichever is longer, prior to screening.
- The participant has a Montréal Cognitive Assessment (MoCA) score ≤24 (adjusted for education).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF28996Lu AF28996 will be administered orally per schedule specified in the arm description. | Drug | Lu AF28996 |
| PlaceboPlacebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description. | Drug | Placebo |
Primary outcome
Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries
Time frame: Baseline, Week 19
27 secondary outcomes
Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries
Time frame: Baseline, Week 19
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
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
Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction
Time frame: Week 19
Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day
Time frame: Week 19
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
Change From Baseline to Week 19 in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Baseline, Week 19
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
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
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
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
Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score
Time frame: Baseline, Week 19
Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score
Time frame: Baseline, Week 19
Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score
Time frame: Baseline, Week 19
Change From Baseline to Week 19 in Participant's Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Time frame: Baseline, Week 19
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
Change From Baseline to Week 19 in Daily Oral Levodopa (mg)
Time frame: Baseline, Week 19
Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED)
Time frame: Baseline, Week 19
Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LEDD)
Time frame: Baseline, Week 19
Patient Global Impression of Change (PGI-C) Score at Week 19
Time frame: Week 19
Plasma Concentrations of Lu AF28996 and Metabolites
Time frame: Weeks 7 and 15
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
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
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
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
Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19
Time frame: Week 19
Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19
Time frame: Week 19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AF28996 in people with Parkinson's Disease, run by H. Lundbeck A/S at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries (time frame: Baseline, Week 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.