NCT01770080

Efficacy of Euminz® for Tension-Type Headache

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Euminz®	3 to 5 time topical use of study drug.
DRUG	Placebo	3 to 5 time topical use of study drug.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-01-17
• Last updated: 2015-12-30

Locations

1 site across 1 country: Germany