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

ConditionParkinson's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorH. Lundbeck A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lu AF28996

    Drug

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

  • Placebo

    Drug

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Lu AF28996Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov
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