Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01408069
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2011-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Sponsor:
EMS
Organization:
Study Overview
Official Title:
Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study canceled by decision strategically.
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 non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.
Detailed Description:
* Open-label, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 56 days.
* 04 visits (days -7, 0, 28 and 56).
* Efficacy will be evaluated for 10 episodes of tension-type headache.
* Adverse events evaluation.
* Experiment duration: 56 days.
* 04 visits (days -7, 0, 28 and 56).
* Efficacy will be evaluated for 10 episodes of tension-type headache.
* Adverse events evaluation.
Study Oversight
Has Oversight DMC:
True
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?: