A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations
Recruiting
Phase 2Interventional Study
Parkinson's Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
H. Lundbeck A/S · Industry
Who this trial is looking for
This trial is looking for adults with Parkinson's disease who have motor fluctuations even while taking their usual medications. Participants will take Lu AF28996 in addition to their current treatment to see if it helps control their movement symptoms better.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease for at least 3 years.
I am 30 years old or older.
I have daily noticeable changes in my movement that cause me trouble.
I have a modified Hoehn and Yahr scale stage of 3 or lower while moving well and between 2 and 4 while not moving well.
You may not be able to join if
I have previously taken Lu AF28996.
I participated in another clinical trial within the last 30 days.
I am pregnant, breastfeeding, or planning to become pregnant.
I have taken any other investigational medications in the last 3 months.
I have a cognitive assessment score of 24 or lower.
I have another type of Parkinsonism or related disorder.
I have severe uncontrollable involuntary movements that could interfere with my safety.
I have unpredictable changes in my movement symptoms.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 sy…
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.
Trial Locations
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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 particip…
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 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).
* 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
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