Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172094
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2005-09-09
Brief Title:
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches
Status:
COMPLETED
Status Verified Date:
2021-05
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 was to evaluate the effectiveness and safety of a single oral dose of NPS 1776 in the acute treatment of migraine pain and associated symptoms
Detailed Description:
Migraine the most common cause of recurrent severe or disabling headache is diagnosed on the basis of a clinical history of intermittent headache with autonomic constitutional and neurologic disturbances
Many antiepileptic drugs AEDs have demonstrated efficacy as acute andor prophylaxis therapy for migraine even though the mechanism of action of the various AEDs is poorly understood
NPS 1776 isovaleramide is a neutral aliphatic amide The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear The same is true for many antiepileptics on the market today NPS 1776 does not appear to bind directly to various CNS receptor centers although it shows a broad range of anticonvulsant activity in multiple animal models of seizures This broad profile of anticonvulsant activity is similar to that of valproic acid VPA and may also predict NPS 1776 efficacy in the treatment of migraine
Many antiepileptic drugs AEDs have demonstrated efficacy as acute andor prophylaxis therapy for migraine even though the mechanism of action of the various AEDs is poorly understood
NPS 1776 isovaleramide is a neutral aliphatic amide The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear The same is true for many antiepileptics on the market today NPS 1776 does not appear to bind directly to various CNS receptor centers although it shows a broad range of anticonvulsant activity in multiple animal models of seizures This broad profile of anticonvulsant activity is similar to that of valproic acid VPA and may also predict NPS 1776 efficacy in the treatment of migraine
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