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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766813
• Other study ID #: ITI-214-202
• Status: Recruiting
• Phase: Phase 2
• Start date: March 13, 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646-440-9333
• Email: ITCIClinicalTrials[@]itci-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Lenrispodun
Lenrispodun 30 mg tablets administered orally, once daily.
• Placebo
Matching tablets administered orally, once daily.

Locations

Country	Name	City	State
United States	Clinical Site	Altamonte Springs	Florida
United States	Clinical Site	Augusta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Boca Raton	Florida
United States	Clinical Site	Coral Springs	Florida
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Falls Church	Virginia
United States	Clinical Site	Farmington Hills	Michigan
United States	Clinical Site	Golden Valley	Minnesota
United States	Clinical Site	Hallandale Beach	Florida
United States	Clinical Site	Henrico	Virginia
United States	Clinical Site	Irvine	California
United States	Clinical Site	Kansas City	Kansas
United States	Clinical Site	Kirkland	Washington
United States	Clinical Site	Memphis	Tennessee
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Milwaukee	Wisconsin
United States	Clinical Site	Ocala	Florida
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Palm Beach Gardens	Florida
United States	Clinical Site	Phoenix	Arizona
United States	Clinical Site	Port Orange	Florida
United States	Clinical Site	Reseda	California
United States	Clinical Site	Rock Hill	South Carolina
United States	Clinical Site	Scottsdale	Arizona
United States	Clinical Site	Spokane	Washington
United States	Clinical Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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.	Day 29