Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 8:37 PM
Study NCT ID:
NCT02185703
Status:
TERMINATED
Last Update Posted:
2015-08-05
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chordate System S020 Acute Migraine Clinical Investigation
Sponsor:
Chordate Medical
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Too slow recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Amici
Brief Summary:
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
Detailed Description:
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.
After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
Study Oversight
Has Oversight DMC:
False
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?: