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

Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408069

Enrollment

Registered

2011-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tensional-type Headache

Keywords

headache, migraine

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.

Interventions

DRUGMIGRANE

1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)

DRUGPARCEL

1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026