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

Migraine Disorders Clinical Trial

— ParMig  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190044
• Other study ID #: ParMig Study
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: University of Roma La Sapienza
• Contact: Cherubino Di Lorenzo, PhD
• Phone: +393286783246
• Email: cherubino.dilorenzo[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Dietary Supplement:
• PACR
Daily assumption of PACR for a 3-month period
• Placebo
Daily assumption of placebo

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (3)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Francesco Pierelli, Gianluca Coppola

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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