Efficacy of Euminz® for Tension-Type Headache
NCT01770080 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211
Last updated 2015-12-30
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
Interventions
- DRUG
-
Euminz®
3 to 5 time topical use of study drug.
- DRUG
-
3 to 5 time topical use of study drug.
Sponsors & Collaborators
-
Cassella-med GmbH & Co. KG
collaborator INDUSTRY -
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Yatin Shah, MD · Charite University, Berlin, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- Germany
Study Locations
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