Efficacy of Euminz® for Tension-Type Headache

NCT01770080 | Completed Phase 4 DMC

• 1 other identifier: 2011-004777-89
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief 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 evaluated for primary objectives, following attacks during study duration will be observed and documented. Study duration per patient: 10 weeks

Conditions

Episodic Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  10 weeks

Other Outcomes (1)

• Safety

  48 hours

Study Arms (2)

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).

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).

Drug: Placebo

Interventions

Euminz® DRUG

3 to 5 time topical use of study drug.

Also known as: Peppermint oil (10% ethanolic solution).

Euminz®

Placebo DRUG

3 to 5 time topical use of study drug.

Also known as: Peppermint oil (0,5% ethanolic solution).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with headache attacks lasting from 30 minutes to 7 days
• At least two of the following pain characteristics are present:
• \- 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)
• months retrospective history
• Willingness and ability to keep the patient's diary and to comply with the procedures of the study
• Written informed consent

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Cassella-med GmbH & Co. KG: collaborator

Study Sites (1)

Charité, Chair of Complementary and Integrative Medicine

Berlin, State of Berlin, 14109, Germany

Location

MeSH Terms

Interventions

peppermint oil

Study Officials

• Yatin Shah, MD

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 17, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

DE (1)