Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384774
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2006-10-04
Brief Title:
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Placebo-Controlled Group Sequential Adaptive Treatment Assignment Study of Intravenous COL-144 LY573144 in the Acute Treatment of Migraine
Status:
COMPLETED
Status Verified Date:
2018-01
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 study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies
Detailed Description:
This study is set up
to evaluate the efficacy headache response at two hours of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation
to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including headache response proportion of participants pain-free headache recurrence nausea photophobia phonophobia disability use of rescue medication patient global impression and vomiting
to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events physical exam vital signs laboratory evaluations and ECGs
to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response
to evaluate the efficacy headache response at two hours of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation
to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including headache response proportion of participants pain-free headache recurrence nausea photophobia phonophobia disability use of rescue medication patient global impression and vomiting
to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events physical exam vital signs laboratory evaluations and ECGs
to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response
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 |
|---|---|---|---|
| 2006-003903-38 | EUDRACT_NUMBER | None | None |
| COL MIG-201 | OTHER | None | None |
| H8H-CD-LAHM | OTHER | Eli Lilly and Company | None |