Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766813
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-02-24
Brief Title:
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinsons Disease
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies Inc
Study Overview
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 Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled parallel-group fixed-dose study in patients with a diagnosis of Parkinsons Disease consistent with the UK Parkinsons 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 mgday in 11 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
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 mgday in 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None