Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334178
Status:
COMPLETED
Last Update Posted:
2007-09-10
First Post:
2006-06-05
Brief Title:
Evaluation of the Efficacy and Safety of Laxymig as Prophylactic Treatment in Patients With Migraine
Sponsor:
Lotus Pharmaceutical
Organization:
Lotus Pharmaceutical
Study Overview
Official Title:
A Multi-Center Randomized Parallel Double-Blind Placebo-Controlled Study in Evaluation the Efficacy and Safety of Laxymig ER as Prophylactic Treatment in Patients With Migraine
Status:
COMPLETED
Status Verified Date:
2007-09
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:
The purpose of this study is to evaluate the efficacy and safety of Laxymig ER compared with placebo in prophylactic monotherapy treatment of migraine headache
Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of Laxymig ER compared with placebo in prophylactic monotherapy treatment of migraine headache
Four weeks baseline following with 12 weeks treatment phase Subjects migraine are recorded by diary cards and re-evaluated by the investigator
Subject will have visit every 4-week - 7 days
Four weeks baseline following with 12 weeks treatment phase Subjects migraine are recorded by diary cards and re-evaluated by the investigator
Subject will have visit every 4-week - 7 days
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