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WithdrawnNCT01408069Updated Feb 24, 2021

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

A Phase 3 interventional study of MIGRANE and PARCEL in Tensional-type Headache, sponsored by EMS. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Study canceled by decision strategically.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Tensional-type Headache

Browse trials for

Keywords

  • headache
  • migraine
03

In context

Headache

1,226 studies on the registry are indexed under Headache; 202 are open to participants now.

Browse Headache studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MIGRANE

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

    Drug: MIGRANE

  • Active comparator
    PARCEL

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

    Drug: PARCEL

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)

06

What researchers measure

Primary outcomes

  1. Efficacy of treatment in relieve headache symptoms.

    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.

    Time frame: 1 hour

Secondary outcomes

  1. Tolerability of study treatment

    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.

    Time frame: 56 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01408069
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Aug 3, 2011
Last update
Feb 24, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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