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Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis (ParMig)

This study is currently recruiting participants.
Verified June 2017 by Cherubino DI LORENZO, University of Roma La Sapienza
Sponsor:
ClinicalTrials.gov Identifier:
NCT03190044
First Posted: June 16, 2017
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Gianluca Coppola
Francesco Pierelli
Information provided by (Responsible Party):
Cherubino DI LORENZO, University of Roma La Sapienza
  Purpose
Migraine is a highly disabling disorder that affects hundreds of millions of people around the world. Yet, a little number of prophylactic treatments are available still now. The limited number of available drugs leads to a wide use of nutraceutical compounds in migraine therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do not know if these combinations are really more effective than the single compounds alone, or an anti-synergic effect could be present because of a reciprocal antagonism of effects. For this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium, andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a randomized controlled double blind study.

Condition Intervention
Migraine Disorders Dietary Supplement: PACR Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:
Placebo and 'verum' pills have the similar shape and colour.
Primary Purpose: Prevention
Official Title: A Fixed Combination of Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) as Prophylactic Treatment for Migraine: a Randomized Controlled Double Blind Study (ParMig Study)

Resource links provided by NLM:


Further study details as provided by Cherubino DI LORENZO, University of Roma La Sapienza:

Primary Outcome Measures:
  • Migraine improvement in terms of responder rate [ Time Frame: 3 months ]
    Number of subjects that at least have a reduction of 50% in terms of migraine frequency


Secondary Outcome Measures:
  • Migraine improvement in terms of frequencies [ Time Frame: 3 months ]
    reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.


Estimated Enrollment: 82
Actual Study Start Date: June 6, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Migraineurs (verum)
One pill per day of PACR: magnesium 281,25 mg; partenium 150 mg (partenolides 1200mcg); andrographis 100 mg (andrographolides 10 mg); co-enzyme Q10 20 mg; riboflavin 4,8 mg.
Dietary Supplement: PACR
Daily assumption of PACR for a 3-month period
Placebo Comparator: Migranineurs (placebo)
One pill per day of placebo: Cellulose
Dietary Supplement: Placebo
Daily assumption of placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of migraine (with or without aura)
  • both genders
  • age between 18 and 65 y.o.
  • more than 1 year of migraine history
  • no other headache conditions
  • a migraine frequency between 2 and 8 per month

Exclusion Criteria:

  • Prophylactic treatments in the last 3 months
  • pregnancy or lactation
  • other medical conditions that requires a daily drug assumption
  • intolerance or allergic reactions to some of compounds of the product.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190044


Locations
Italy
Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Cherubino Di Lorenzo, MD, PhD    +393286783246    cherubino.dilorenzo@uniroma1.it   
Contact: Francesco Pierelli, MD       francesco.pierelli@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Gianluca Coppola
Francesco Pierelli
  More Information

Responsible Party: Cherubino DI LORENZO, Research Fellow, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03190044     History of Changes
Other Study ID Numbers: ParMig Study
First Submitted: June 6, 2017
First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Riboflavin
Coenzyme Q10
Ubiquinone
Andrographolide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors