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Headache Disorders, Primary | IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice

Headache Disorders, Primary research study

What is the primary objective of this study?

Headaches are a common medical problem that physicians frequently encounter in their practice. One of key findings of The Atlas of Headache Disorders prepared by World Health Organization (WHO) is: headache disorders, including migraine and tension-type headache (TTH), are among the most prevalent disorders of mankind. The fixed combination of indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is widely used in common daily practice only in Italy from early 1970s, is available at the Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of primary headache (migraine with or without aura and/or episodic TTH) and whose headache attacks required acute pharmacological treatment. - Were administered IndoProCaf (Difmetre®) effervescent tablets therapy according to the local product labelling. - Adults 18 years and older (male, female). - Provide Authorization to the investigator to use and/or disclose personal and/or health data. Exclusion Criteria: - Meet contraindications for treatment with IndoProCaf (Difmetre®) effervescent tablets as outlined in the latest version of local product labelling. - Patients who are required prescription by physician of IndoProCaf and nonsteroidal anti-inflammatory drug-containing products at the same time for acute headache attacks treatment. - Previous discontinuation of IndoProCaf treatment due to safety (i.e. hypersensitivity) events, lack of efficacy. - Female patients who are pregnant or are breast-feeding.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Headache Disorders, Primary

Migraine With Aura

Migraine Without Aura

Tension-Type Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

primary headachesAdults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice

Study Status

Completed

Start Date: June 2014

Completed Date: November 2015

Phase:

Type: Observational

Design:

Primary Outcome: Percentage of Patients With Significant Pain Reduction

Secondary Outcome: Time to Significant Pain Reduction

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Pascal Berrou, MD

Lead Sponsor: Abbott

Collaborator: Almedis

More information:https://clinicaltrials.gov/show/NCT02115269

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