Tensional-type HeadachePhase 3NCT01408069
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
A Phase 3 study testing MIGRANE and PARCEL in people with Tensional-type Headache, run by EMS.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tensional-type Headache
- What is being tested?
- MIGRANE and PARCEL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Tensional-type headache patients according to the International Headache Society criteria.
- Corporal body indices < 40.
Who cannot join
- Pregnancy or risk of pregnancy.
- Lactation
- Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
- Use of immunosuppressive drugs.
- Alterations of laboratory selective tests.
- Drugs or alcohol abuse
About this study
Official title: Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
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.
- Conditions
- Tensional-type Headache
- Being tested
- MIGRANE, PARCEL
- Keywords
- headache, migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIGRANEDrug
1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)
PARCELDrug
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
| Study group | Role | What they receive |
|---|---|---|
| MIGRANE | Experimental | 1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg Receives: Drug: MIGRANE |
| PARCEL | Active comparator | 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) Receives: Drug: PARCEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
Why it stopped: Study canceled by decision strategically.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tensional-type HeadacheStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408069
- Sponsor's protocol ID
- ACHEMS0211
- Status last verified
- Feb 2021
- First submitted
- 1 Aug 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
- ClinicalTrials.gov ID
- NCT01408069
- Acronym / sponsor ID
- ACHEMS0211
- Conditions
- Tensional-type Headache
- Keywords
- headache, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study canceled by decision strategically.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIGRANE | Experimental | Drug: MIGRANE1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg |
| PARCEL | Active comparator | Drug: PARCEL1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Tensional-type headache patients according to the International Headache Society criteria.
- Corporal body indices < 40.
Key exclusion criteria (6 listed)
- Pregnancy or risk of pregnancy.
- Lactation
- Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
- Use of immunosuppressive drugs.
- Alterations of laboratory selective tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIGRANE1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg) | Drug | MIGRANE |
| PARCEL1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) | Drug | PARCEL |
Primary outcome
Efficacy of treatment in relieve headache symptoms.
Time frame: 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.
1 secondary outcome
Tolerability of study treatment
Time frame: 56 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MIGRANE and PARCEL in people with Tensional-type Headache, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment in relieve headache symptoms. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.