Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00627640
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2008-02-13
Brief Title:
Safinamide in Idiopathic Parkinsons Disease IPD With Motor Fluctuations as add-on to Levodopa
Sponsor:
Newron Pharmaceuticals SPA
Organization:
Newron Pharmaceuticals SPA
Study Overview
Official Title:
A Phase III Double-blind Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mgDay of Safinamide as add-on Therapy in Subjects With Idiopathic Parkinsons Disease With Motor Fluctuations Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist an Anticholinergic andor Amantadine
Status:
COMPLETED
Status Verified Date:
2012-06
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:
SETTLE
Brief Summary:
Parkinsons Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons The understanding that PD is a syndrome of dopamine DA deficiency led to the introduction in the clinical practice of L-dopa a precursor of DA that crosses the blood brain barrier and also to the use of selective inhibitors of MAO-B the major DA metabolising enzyme in man
Safinamide is an inhibitor of MAO-B This is a phase III trial to evaluate the efficacy and safety of safinamide 50 and 100 mg po qam compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinsons Disease
The principal efficacy measure is the increase in mean daily on time during the 18-hr diary recording period
Safinamide is an inhibitor of MAO-B This is a phase III trial to evaluate the efficacy and safety of safinamide 50 and 100 mg po qam compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinsons Disease
The principal efficacy measure is the increase in mean daily on time during the 18-hr diary recording period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 63901 | None | None | None |
| EudraCT Number 2007-002964-90 | None | None | None |