Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinsons Disease
Sponsor:
Second Affiliated Hospital of Soochow University
Organization:
Second Affiliated Hospital of Soochow University
Study Overview
Official Title:
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinsons Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
Objective To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson39s disease Study content Using a randomized double-blind placebo-controlled study design 120 patients with Parkinson39s disease and cognitive impairment were enrolled and the treatment was followed up for 12 weeks dihydroergotine mesylate sustained-release tablets conventional treatment treatment group patients 80 cases placebo conventional treatment control group patients 40 cases and the main indicators were observed the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed and the secondary indicators were observed the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed
Expected results The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients
Expected results The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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