Clinical trial NCT05766813: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: levodopa-induced dyskinesia
ON and OFF state
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female between 40 years of age and older
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:

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), 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;

Primary outcomes:
measure: Hauser Diary
timeFrame: Day 29
Secondary outcomes:
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Day 29
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Site
state: Arizona
city: Irvine
country: United States
facility: Clinical Site
state: California
city: Loma Linda
country: United States
facility: Clinical Site
state: California
city: Altamonte Springs
country: United States
facility: Clinical Site
state: Florida
city: Boca Raton
country: United States
facility: Clinical Site
state: Florida
city: Coral Springs
country: United States
facility: Clinical Site
state: Florida
city: Hallandale Beach
country: United States
facility: Clinical Site
state: Florida
city: Maitland
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Ocala
country: United States
facility: Clinical Site
state: Florida
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Port Orange
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Augusta
country: United States
facility: Clinical Site
state: Georgia
city: Decatur
country: United States
facility: Clinical Site
state: Georgia
city: Kansas City
country: United States
facility: Clinical Site
state: Kansas
city: Farmington Hills
country: United States
facility: Clinical Site
state: Michigan
city: Golden Valley
country: United States
facility: Clinical Site
state: Minnesota
city: Albany
country: United States
facility: Clinical Site
state: New York
city: Rock Hill
country: United States
facility: Clinical Site
state: South Carolina
city: Memphis
country: United States
facility: Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Site
state: Texas
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Georgetown
country: United States
facility: Clinical Site
state: Texas
city: Falls Church
country: United States
facility: Clinical Site
state: Virginia
city: Henrico
country: United States
facility: Clinical Site
state: Virginia
city: Kirkland
country: United States
facility: Clinical Site
state: Washington
city: Spokane
country: United States
facility: Clinical Site
state: Washington
city: Milwaukee
country: United States
facility: Clinical Site
state: Wisconsin
Study officials:
References: