Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia

Phase 3

Withdrawn

• Conditions: Tensional-type Headache
• Interventions: Drug: MIGRANE; Drug: PARCEL

• Registration Number: NCT01408069
• Lead Sponsor: EMS

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.

Study Timeline

• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Tensional-type headache patients according to the International Headache Society criteria.
3. Corporal body indices < 40.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
4. Use of immunosuppressive drugs.
5. Alterations of laboratory selective tests.
6. Drugs or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIGRANE	MIGRANE	1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
PARCEL	PARCEL	1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in relieve headache symptoms.	1 hour	The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after 30, 60 and 90 minutes of initiation of treatment.

Secondary Outcome Measures

Name	Time	Method
Tolerability of study treatment	56 days	Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm.