Actively Recruiting
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
Led by Intra-Cellular Therapies, Inc. · Updated on 2024-10-23
132
Participants Needed
31
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 years or older
- Body mass index between 19.0 and 40.0 kg/m2
- Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank criteria
- Hoehn and Yahr stage 2 or 3 while in the ON state
- Clinically meaningful response to levodopa (levodopa + DDCI combination)
- Stable and optimal levodopa dose (minimum 100 mg three times daily) for at least 4 weeks before screening, with plans to continue during treatment
- Stable dose of other anti-parkinsonian medications (if any) for at least 4 weeks before screening, with plans to continue during treatment
- Experiencing wearing-off symptoms and levodopa-induced dyskinesia
- Ability to complete and return a Hauser Diary for motor function during screening
- Has a caregiver to assist with study participation if needed
You will not qualify if you...
- History of parkinsonism other than idiopathic Parkinson's Disease, including progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, or primary dystonia
- Late-stage Parkinson's Disease, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, or unpredictable/widely swinging symptom fluctuations
- Signs of dementia with MMSE-2:SV score of 24 or lower
- Use of moderate or strong CYP3A4 inhibitors within 5 half-lives before baseline or CYP3A4 inducers within 2 weeks before baseline
- Daily use of nonsteroidal anti-inflammatory drugs except acetylsalicylic acid
- Use of MAO-A inhibitors, phosphodiesterase type 5 inhibitors, or alpha blockers including tamsulosin within 5 half-lives before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Clinical Site
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Clinical Site
Scottsdale, Arizona, United States, 85251
Actively Recruiting
3
Clinical Site
Irvine, California, United States, 92697
Actively Recruiting
4
Clinical Site
Loma Linda, California, United States, 92354
Actively Recruiting
5
Clinical Site
Altamonte Springs, Florida, United States, 32714
Actively Recruiting
6
Clinical Site
Boca Raton, Florida, United States, 33486
Actively Recruiting
7
Clinical Site
Coral Springs, Florida, United States, 33067
Actively Recruiting
8
Clinical Site
Hallandale, Florida, United States, 33009
Actively Recruiting
9
Clinical Site
Maitland, Florida, United States, 32751
Not Yet Recruiting
10
Clinical Site
Miami, Florida, United States, 33136
Actively Recruiting
11
Clinical Site
Ocala, Florida, United States, 34470
Actively Recruiting
12
Clinical Site
Orlando, Florida, United States, 32804
Actively Recruiting
13
Clinical Site
Orlando, Florida, United States, 32825
Actively Recruiting
14
Clinical Site
Port Orange, Florida, United States, 32127
Actively Recruiting
15
Clinical Site
Tampa, Florida, United States, 33612
Actively Recruiting
16
Clinical Site
Augusta, Georgia, United States, 30912
Actively Recruiting
17
Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
18
Clinical Site
Kansas City, Kansas, United States, 66160
Actively Recruiting
19
Clinical Site
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
20
Clinical Site
Golden Valley, Minnesota, United States, 55427
Actively Recruiting
21
Clinical Site
Albany, New York, United States, 12208
Not Yet Recruiting
22
Clinical Site
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
23
Clinical Site
Memphis, Tennessee, United States, 38157
Actively Recruiting
24
Clinical Site
Austin, Texas, United States, 78746
Actively Recruiting
25
Clinical Site
Dallas, Texas, United States, 75243
Actively Recruiting
26
Clinical Site
Georgetown, Texas, United States, 78628
Actively Recruiting
27
Clinical Site
Falls Church, Virginia, United States, 22042
Actively Recruiting
28
Clinical Site
Henrico, Virginia, United States, 23233
Actively Recruiting
29
Clinical Site
Kirkland, Washington, United States, 98034
Actively Recruiting
30
Clinical Site
Spokane, Washington, United States, 99202
Actively Recruiting
31
Clinical Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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