Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
NCT ID: NCT05766813
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
132 participants
INTERVENTIONAL
2023-03-13
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
NCT02782481
ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
NCT01336088
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
NCT04006210
EMD 128130 for the Treatment of Parkinson's Disease
NCT00009048
Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
NCT02812147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
* Double-blind Treatment Period (4 weeks) in which all patients will be randomized to receive placebo or Lenrispodun 30 mg/day in 1:1 ratio.
* Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lenrispodun 30 mg
Lenrispodun 30 mg tablets administered orally, once-daily.
Lenrispodun
Lenrispodun 30 mg tablets administered orally, once daily.
Placebo
Matching tablets administered orally, once daily.
Placebo
Matching tablets administered orally, once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lenrispodun
Lenrispodun 30 mg tablets administered orally, once daily.
Placebo
Matching tablets administered orally, once daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body mass index of 19.0-40.0 kg/m2;
3. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
4. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
5. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
1. 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;
2. 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;
7\. 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.
9\. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
Exclusion Criteria
2. 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;
3. Exhibits clinical signs of dementia as indicated by the Mini-Mental State Examination, 2nd Edition: Standard Version (MMSE-2:SV) score of ≤ 24;
4. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
5. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA);
6. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Site
Phoenix, Arizona, United States
Clinical Site
Scottsdale, Arizona, United States
Clinical Site
Irvine, California, United States
Clinical Site
Loma Linda, California, United States
Clinical Site
Altamonte Springs, Florida, United States
Clinical Site
Boca Raton, Florida, United States
Clinical Site
Coral Springs, Florida, United States
Clinical Site
Hallandale, Florida, United States
Clinical Site
Maitland, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Ocala, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Port Orange, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Augusta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Kansas City, Kansas, United States
Clinical Site
Farmington Hills, Michigan, United States
Clinical Site
Golden Valley, Minnesota, United States
Clinical Site
Albany, New York, United States
Clinical Site
Rock Hill, South Carolina, United States
Clinical Site
Memphis, Tennessee, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Georgetown, Texas, United States
Clinical Site
Falls Church, Virginia, United States
Clinical Site
Henrico, Virginia, United States
Clinical Site
Kirkland, Washington, United States
Clinical Site
Spokane, Washington, United States
Clinical Site
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITI-214-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.