Episodic Tension-Type HeadachePhase 4CAS/B/016611NCT01770080
Efficacy of Euminz® for Tension-Type Headache
A Phase 4 study testing Euminz® in people with Episodic Tension-Type Headache, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH). Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups design; Randomisation 1:1; First attack per patient will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Episodic Tension-Type Headache
- What is being tested?
- Euminz®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Sep 2015
- Phase
- Phase 4
- 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
- Male and female patients from 18 years onwards
- History of ETTH for at least one year. The number of days with such a headache is ≥2 per month
- Onset of TTH below 65 years of age
- At least 10 previous headache attacks fulfilling the following four inclusion criteria:
- Patients with headache attacks lasting from 30 minutes to 7 days
- At least two of the following pain characteristics are present:
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- - Pressing or tightening (non-pulsating) quality
- - Intensity of pain: moderate = unable to ignore (pain may inhibit, but does not prohibit activities)
- - Bilateral location
- - No aggravation by walking stairs or similar routine physical activity
- Headache is not accompanied by nausea or vomiting (anorexia may occur)
- Headache is not accompanied by a combination of the following symptoms: photophobia and phonophobia (only one may be present)
- 3 months retrospective history
- Willingness and ability to keep the patient's diary and to comply with the procedures of the study
- Written informed consent
Who cannot join
- Headaches other than TTH: (e.g. migraine, cluster headache, hypertension headache, drug-related headache,analgesic-induced headache,post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month)
- Presence of oromandibular dysfunction
- History of facial or cranial surgery
- Use of prophylactic drugs for headache within one month prior to enrolment
- Use of drugs for acute TTH treatment for ≥ 10 days of headache per month
- Anticipated problems in adhering to the self-observation procedure (e.g. because of work)
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- Abuse of alcohol, narcotics or other drugs
- Serious illnesses within the last 3 months (e.g. myocardial infarction, cardiac insufficiency NYHA III and IV, low blood pressure, cerebral insult, diabetes mellitus, neuropathy, changes in the skin or neoplasms in the head)
- Epilepsy
- Intake of anti-psychotic, anti-depressant or anti-epileptic medication during the previous month
- Intake of long-acting non-steroidal anti-inflammatory drugs within the last month
- Planned start of new pharmacological or non-pharmacological therapies
- Any significant skin condition affecting face or neck
- Known hypersensitivity towards peppermint oil
- Previous use of Euminz® or any other essential oil solutions for headache in the last three months
- Participation in another clinical trial within the last month
- Accommodation in an institution at judicial or official request
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité, Chair of Complementary and Integrative Medicine
Berlin, State of Berlin, 14109
About this study
Official title: Efficacy and Safety of Euminz® (10% Ethanolic Solution of Peppermint Oil for Topical Use) Compared to Placebo in Patients With Episodic Tension-type Headache (ETTH); Phase IV Clinical Trial
Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH).
Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives, following attacks during study duration will be observed and documented.
Study duration per patient: 10 weeks
Read the detailed description
To demonstrate the efficacy of Euminz® to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache. The two primary objectives will be tested hierarchically (a-priory ordered) to avoid alpha-adjustment:
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS). Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).
Second primary objective of the first headache episode will be the decrease of intensity of pain measured by a visual analogue scale (VAS). The difference from measure point 0 (before first application of Euminz®) on the VAS in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representing the pain intensity difference (PID).
- Conditions
- Episodic Tension-Type Headache
- Being tested
- Euminz®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euminz®Drug
Also called Peppermint oil (10% ethanolic solution).
3 to 5 time topical use of study drug.
PlaceboDrug
Also called Peppermint oil (0,5% ethanolic solution).
3 to 5 time topical use of study drug.
| Study group | Role | What they receive |
|---|---|---|
| Euminz® | Active comparator | Acute treatment (3 to 5 time topical use of Euminz® = 10%ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS). Receives: Drug: Euminz® |
| Placebo | Placebo comparator | Acute treatment (3 to 5 time topical use of Placebo= 0,5% ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS).
Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).
Measured: 2 hours
Secondary outcomes (1)
Further headache attacks will be documented and evaluated during study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Cassella-med GmbH & Co. KG
- Responsible party
- Principal investigator, Rainer Stange, Charite University, Berlin, Germany
- Investigators
- Yatin Shah, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770080
- Sponsor's protocol ID
- 2011-004777-89
- Acronym
- CAS/B/016611
- Status last verified
- Dec 2015
- First submitted
- 9 Jan 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Euminz® (10% Ethanolic Solution of Peppermint Oil for Topical Use) Compared to Placebo in Patients With Episodic Tension-type Headache (ETTH); Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT01770080
- Acronym / sponsor ID
- CAS/B/016611 / 2011-004777-89
- Conditions
- Episodic Tension-Type Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Cassella-med GmbH & Co. KG
- Study start
- Feb 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Jan 2013 (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.
Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH).
Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives, following attacks during study duration will be observed and documented.
Study duration per patient: 10 weeks
Detailed description
To demonstrate the efficacy of Euminz® to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache. The two primary objectives will be tested hierarchically (a-priory ordered) to avoid alpha-adjustment:
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS). Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).
Second primary objective of the first headache episode will be the decrease of intensity of pain measured by a visual analogue scale (VAS). The difference from measure point 0 (before first application of Euminz®) on the VAS in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representing the pain intensity difference (PID).
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 |
|---|---|---|
| Euminz® | Active comparator | Drug: Euminz®Acute treatment (3 to 5 time topical use of Euminz® = 10%ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS). |
| Placebo | Placebo comparator | Drug: PlaceboAcute treatment (3 to 5 time topical use of Placebo= 0,5% ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male and female patients from 18 years onwards
- History of ETTH for at least one year. The number of days with such a headache is ≥2 per month
- Onset of TTH below 65 years of age
- At least 10 previous headache attacks fulfilling the following four inclusion criteria:
- Patients with headache attacks lasting from 30 minutes to 7 days
Key exclusion criteria (17 listed)
- Headaches other than TTH: (e.g. migraine, cluster headache, hypertension headache, drug-related headache,analgesic-induced headache,post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month)
- Presence of oromandibular dysfunction
- History of facial or cranial surgery
- Use of prophylactic drugs for headache within one month prior to enrolment
- Use of drugs for acute TTH treatment for ≥ 10 days of headache per month
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 |
|---|---|---|
| Euminz®Also: Peppermint oil (10% ethanolic solution).3 to 5 time topical use of study drug. | Drug | Euminz® |
| PlaceboAlso: Peppermint oil (0,5% ethanolic solution).3 to 5 time topical use of study drug. | Drug | Placebo |
Primary outcome
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS).
Time frame: 2 hours
Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).
1 secondary outcome
Further headache attacks will be documented and evaluated during study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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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.
Yatin Shah, MD study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Euminz® in people with Episodic Tension-Type Headache, run by Charite University, Berlin, Germany at 1 site in Germany.
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 15 inclusion and 17 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: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS). (time frame: 2 hours). 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 30 Dec 2015.