The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05766813
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Lenrispodun Drug: Placebo Phase 2

Detailed Description:

The study will be conducted in three periods:

  • 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lenrispodun 30 mg
Lenrispodun 30 mg tablets administered orally, once-daily.
 Drug: Lenrispodun
Lenrispodun 30 mg tablets administered orally, once daily.
Placebo Comparator: Placebo
Matching tablets administered orally, once daily.
 Drug: Placebo
Matching tablets administered orally, once daily.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hauser Diary [ Time Frame: Day 29 ]
    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.


Secondary Outcome Measures :
  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Day 29 ]

    The MDS-UPDRS evaluates various aspects of Parkinson's disease and has four parts: Part I (Non-motor Aspects of Experiences of Daily Living), Part II (Motor Aspects of Experiences of Daily Living), Part III (Motor Examination), and Part IV (Motor Complications). The MDS-UPDRS evaluates various aspects of Parkinson's disease and has four parts: Part I (Non-motor Aspects of Experiences of Daily Living), Part II (Motor Aspects of Experiences of Daily Living), Part III (Motor Examination), and Part IV (Motor Complications).

    Each parkinsonian sign or symptom on the MDS-UPDRS is rated on a 5-point scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between 40 and 80 years of age, inclusive
  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 consecutive days (ie, 3 consecutive, 24-hour periods), 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:

  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. 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) or 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;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05766813


Contacts
Layout table for location contacts
Contact: ITI Clinical Trials 646-440-9333 ITCIClinicalTrials@itci-inc.com

Locations
Layout table for location information
United States, Arizona
Clinical Site Not yet recruiting
Phoenix, Arizona, United States, 85013
Clinical Site Not yet recruiting
Scottsdale, Arizona, United States, 85251
United States, California
Clinical Site Recruiting
Irvine, California, United States, 92697
Clinical Site Recruiting
Reseda, California, United States, 91335
United States, Florida
Clinical Site Recruiting
Altamonte Springs, Florida, United States, 32714
Clinical Site Recruiting
Boca Raton, Florida, United States, 33486
Clinical Site Recruiting
Coral Springs, Florida, United States, 33067
Clinical Site Recruiting
Hallandale Beach, Florida, United States, 33009
Clinical Site Not yet recruiting
Miami, Florida, United States, 33136
Clinical Site Recruiting
Ocala, Florida, United States, 34470
Clinical Site Recruiting
Orlando, Florida, United States, 32804
Clinical Site Recruiting
Palm Beach Gardens, Florida, United States, 33410
Clinical Site Recruiting
Port Orange, Florida, United States, 32127
Clinical Site Not yet recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Clinical Site Recruiting
Augusta, Georgia, United States, 30912
Clinical Site Recruiting
Decatur, Georgia, United States, 30030
United States, Kansas
Clinical Site Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
Clinical Site Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Clinical Site Recruiting
Golden Valley, Minnesota, United States, 55427
United States, South Carolina
Clinical Site Recruiting
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Clinical Site Recruiting
Memphis, Tennessee, United States, 38157
United States, Texas
Clinical Site Not yet recruiting
Austin, Texas, United States, 78746
United States, Virginia
Clinical Site Not yet recruiting
Falls Church, Virginia, United States, 22042
Clinical Site Not yet recruiting
Henrico, Virginia, United States, 23233
United States, Washington
Clinical Site Not yet recruiting
Kirkland, Washington, United States, 98034
Clinical Site Recruiting
Spokane, Washington, United States, 99202
United States, Wisconsin
Clinical Site Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT05766813    
Other Study ID Numbers: ITI-214-202
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intra-Cellular Therapies, Inc.:
levodopa-induced dyskinesia
ON and OFF state
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases