RECRUITING

Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-13
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female between 40 years of age and older
  2. 2. Body mass index of 19.0-40.0 kg/m2;
  3. 3. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
  4. 4. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
  5. 5. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
  6. 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;
  7. 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;
  8. 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. 9. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
  1. 1. 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;
  2. 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. 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. 4. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
  5. 5. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA);
  6. 6. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;

Contacts and Locations

Study Contact

ITI Clinical Trials
CONTACT
646-440-9333
ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

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 Beach, 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

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-03-13
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • levodopa-induced dyskinesia
  • ON and OFF state

Additional Relevant MeSH Terms

  • Parkinson Disease