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

NCT03190044 | Unknown

• 1 other identifier: ParMig Study
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Migraine improvement in terms of frequencies

  3 months

Study Arms (2)

Migraineurs (verum)

EXPERIMENTAL

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

Migranineurs (placebo)

PLACEBO COMPARATOR

One pill per day of placebo: Cellulose

Dietary Supplement: Placebo

Interventions

PACR DIETARY_SUPPLEMENT

Daily assumption of PACR for a 3-month period

Migraineurs (verum)

Placebo DIETARY_SUPPLEMENT

Daily assumption of placebo

Migranineurs (placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Gianluca Coppola: collaborator
• Francesco Pierelli: collaborator

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Francesco Pierelli, MD

  University of Roma La Sapienza

  STUDY CHAIR

Central Study Contacts

Cherubino Di Lorenzo, PhD

CONTACT

+393286783246; cherubino.dilorenzo@uniroma1.it

Gianluca Coppola, PhD

CONTACT

gianluca.coppola@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Placebo and 'verum' pills have the similar shape and colour.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 16, 2017
• Study Start: June 6, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)