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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Migraine Disorders
• Intervention / Treatment: Dietary supplement: PACR; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cherubino Di Lorenzo, PhD; Phone Number: +393286783246; Email: cherubino.dilorenzo@uniroma1.it
• Study Contact Backup: Name: Gianluca Coppola, PhD; Email: gianluca.coppola@uniroma1.it

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Policlinico Umberto I
    • Contact: Cherubino Di Lorenzo, MD, PhD; Phone Number: +393286783246; Email: cherubino.dilorenzo@uniroma1.it
    • Contact: Francesco Pierelli, MD; Email: francesco.pierelli@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine improvement in terms of responder rate	Number of subjects that at least have a reduction of 50% in terms of migraine frequency	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine improvement in terms of frequencies	reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.	3 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Collaborators: Gianluca Coppola; Francesco Pierelli
• Investigators: Study Chair: Francesco Pierelli, MD, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2017
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (ACTUAL): June 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 9, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: ParMig Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No