Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
1 other identifier
interventional
132
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Mar 2023
Typical duration for phase_2 parkinson-disease
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedOctober 23, 2024
October 1, 2024
2.5 years
February 24, 2023
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hauser Diary
The Hauser Diary is a validated and commonly used patient-self-report home diary to assess motor symptoms in PD. It asks patients to characterize their predominant motor states in 30-minute intervals as Asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.
Day 29
Secondary Outcomes (1)
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Day 29
Study Arms (2)
Lenrispodun 30 mg
EXPERIMENTALLenrispodun 30 mg tablets administered orally, once-daily.
Placebo
PLACEBO COMPARATORMatching tablets administered orally, once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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;
- \. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.
- \. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Clinical Site
Phoenix, Arizona, 85013, United States
Clinical Site
Scottsdale, Arizona, 85251, United States
Clinical Site
Irvine, California, 92697, United States
Clinical Site
Loma Linda, California, 92354, United States
Clinical Site
Altamonte Springs, Florida, 32714, United States
Clinical Site
Boca Raton, Florida, 33486, United States
Clinical Site
Coral Springs, Florida, 33067, United States
Clinical Site
Hallandale, Florida, 33009, United States
Clinical Site
Maitland, Florida, 32751, United States
Clinical Site
Miami, Florida, 33136, United States
Clinical Site
Ocala, Florida, 34470, United States
Clinical Site
Orlando, Florida, 32804, United States
Clinical Site
Orlando, Florida, 32825, United States
Clinical Site
Port Orange, Florida, 32127, United States
Clinical Site
Tampa, Florida, 33612, United States
Clinical Site
Augusta, Georgia, 30912, United States
Clinical Site
Decatur, Georgia, 30030, United States
Clinical Site
Kansas City, Kansas, 66160, United States
Clinical Site
Farmington Hills, Michigan, 48334, United States
Clinical Site
Golden Valley, Minnesota, 55427, United States
Clinical Site
Albany, New York, 12208, United States
Clinical Site
Rock Hill, South Carolina, 29732, United States
Clinical Site
Memphis, Tennessee, 38157, United States
Clinical Site
Austin, Texas, 78746, United States
Clinical Site
Dallas, Texas, 75243, United States
Clinical Site
Georgetown, Texas, 78628, United States
Clinical Site
Falls Church, Virginia, 22042, United States
Clinical Site
Henrico, Virginia, 23233, United States
Clinical Site
Kirkland, Washington, 98034, United States
Clinical Site
Spokane, Washington, 99202, United States
Clinical Site
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 13, 2023
Study Start
March 13, 2023
Primary Completion
September 1, 2025
Study Completion
October 1, 2025
Last Updated
October 23, 2024
Record last verified: 2024-10