ClinicalTrials.gov

History of Changes for Study: NCT05766813
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
Latest version (submitted October 20, 2023) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 10, 2023 None (earliest Version on record)
2 August 9, 2023 Study Status, Contacts/Locations and Study Description
3 October 20, 2023 Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Study NCT05766813
Submitted Date:  March 10, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: ITI-214-202
Brief Title: Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2023
Overall Status: Recruiting
Study Start: March 2023
Primary Completion: November 2024 [Anticipated]
Study Completion: November 2024 [Anticipated]
First Submitted: February 24, 2023
First Submitted that
Met QC Criteria:
March 10, 2023
First Posted: March 13, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
March 10, 2023
Last Update Posted: March 13, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Intra-Cellular Therapies, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Parkinson Disease
Keywords: levodopa-induced dyskinesia
ON and OFF state
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 132 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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;
Open or close this module Contacts/Locations
Central Contact Person: ITI Clinical Trials
Telephone: 646-440-9333
Email: ITCIClinicalTrials@itci-inc.com
Locations: United States, Florida
Clinical Site
[Recruiting]
Port Orange, Florida, United States, 32127
United States, Georgia
Clinical Site
[Recruiting]
Decatur, Georgia, United States, 30030
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services