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 (PRESTO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Abbott
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT02115269
First received: April 9, 2014
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition
Headache Disorders, Primary
Migraine With Aura
Migraine Without Aura
Tension-Type Headache

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: IndoProCaf (Difmetre®) Effervescent Tablets Effectiveness in Acute Treatment of Primary Headaches (Migraine and/or Episodic Tension-type Headache) and Patients' Satisfaction With the Treatment in Routine Clinical Practice in Ukraine and Kazakhstan

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of patients with significant pain reduction [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  • Proportion of patients who are satisfied with IndoProCaf treatment [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]
    defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)


Secondary Outcome Measures:
  • Time to significant pain reduction [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: No ]
    Time will be measured as 1, 2, 4, 6 or 24 hours post-dose; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  • Proportion of patients with significant pain reduction in case of first dose no response [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  • Proportion of patients with significant pain reduction in case of headache relapse [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  • Proportion of patients who are satisfied with different medicines previously used for headache attack [ Time Frame: baseline ] [ Designated as safety issue: No ]
    defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)


Estimated Enrollment: 750
Study Start Date: June 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
primary headaches
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice

Detailed Description:

The study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. No additional procedures (other than the standard of care) shall be applied to the patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with migraine (with or without aura) and/or episodic TTH

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115269

Contacts
Contact: Nadiia Sotnychenko, MD +38 044 498 60 80 ext 6017 nadiia.sotnychenko@abbott.com
Contact: Oleksandr Kuzmenko, MD +38 044 498 60 80 ext 6068 oleksandr.kuzmenko@abbott.com

Locations
Kazakhstan
Research facility ID ORG-000986 Not yet recruiting
Aktobe, Kazakhstan, 030000
Research facility ID ORG-000987 Not yet recruiting
Aktobe, Kazakhstan, 30000
Research facility ID ORG-000988 Not yet recruiting
Aktobe, Kazakhstan, 30000
Research facility ID ORG-000993 Not yet recruiting
Aktobe, Kazakhstan, 300012
Research facility ID ORG-000995 Not yet recruiting
Aktobe, Kazakhstan, 030000
Research facility ID ORG-000994 Recruiting
Almaty, Kazakhstan, 050000
Research facility ID ORG-000996 Not yet recruiting
Almaty, Kazakhstan, 050057
Research facility ID ORG-000990 Not yet recruiting
Astana, Kazakhstan, 010000
Research facility ID ORG-000991 Not yet recruiting
Astana, Kazakhstan, 010000
Research facility ID ORG-000992 Not yet recruiting
Astana, Kazakhstan, 010000
Research facility ID ORG-000984 Not yet recruiting
Karaganda, Kazakhstan, 100008
Research facility ID ORG-000985 Not yet recruiting
Karaganda, Kazakhstan, 100008
Research facility ID ORG-000989 Not yet recruiting
Shymkent, Kazakhstan, 160000
Research facility ID ORG-000997 Not yet recruiting
Uralsk, Kazakhstan, 090005
Ukraine
Research facility ID ORG-000999 Not yet recruiting
Kharkiv, Ukraine, 61176
Research facility ID ORG-000335 Not yet recruiting
Kiev, Ukraine, 04112
Research facility ID ORG-000340 Not yet recruiting
Kiev, Ukraine, 04112
Research facility ID ORG-000998 Not yet recruiting
Luhansk, Ukraine, 91011
Research facility ID ORG-001002 Not yet recruiting
Lutsk, Ukraine, 43005
Research facility ID ORG-001001 Recruiting
Lviv, Ukraine, 79010
Research facility ID ORG-001004 Not yet recruiting
Lviv, Ukraine, 79010
Research facility ID ORG-001000 Not yet recruiting
Mukachevo, Ukraine, 89600
Research faciity ID ORG-001003 Not yet recruiting
Odesa, Ukraine, 65113
Sponsors and Collaborators
Abbott
Almedis
Investigators
Study Director: Jean-Pascal Berrou, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02115269     History of Changes
Other Study ID Numbers: P14-389
Study First Received: April 9, 2014
Last Updated: July 14, 2014
Health Authority: Ukraine: Ethics Committee
Kazakhstan: Ministry of Public Health

Keywords provided by Abbott:
Indoprocaf
Indomethacin
Caffeine
Prochlorperazine
Migraine with Aura
Migraine without Aura
Tension-Type Headache

Additional relevant MeSH terms:
Tension-Type Headache
Headache
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014