Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Par… (NCT05766813) | Clinical Trial Compass
CompletedPhase 2
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
United States79 participantsStarted 2023-03-13
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female between 40 years of age and older
. Body mass index of 19.0-40.0 kg/m2;
. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
. Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If taking other anti-parkinsonian medications (MAO-B \[monoamine oxidase B\] inhibitor, COMT \[catechol-O-methyltransferase\] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
Exclusion criteria
. Medical history indicating parkinsonism other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia;
. Has late-stage PD, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, and/or unpredictable or widely swinging fluctuations in their symptoms as assessed by the Investigator;
. Exhibits clinical signs of dementia as indicated by the Mini-Mental State Examination, 2nd Edition: Standard Version (MMSE-2:SV) score of ≤ 24;
. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA);
. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;