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

NCT ID: NCT03190044

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
Placebo and 'verum' pills have the similar shape and colour.

Study Groups

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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.

Group Type EXPERIMENTAL

PACR

Intervention Type DIETARY_SUPPLEMENT

Daily assumption of PACR for a 3-month period

Migranineurs (placebo)

One pill per day of placebo: Cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Daily assumption of placebo

Interventions

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PACR

Daily assumption of PACR for a 3-month period

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily assumption of placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gianluca Coppola

UNKNOWN

Sponsor Role collaborator

Francesco Pierelli

UNKNOWN

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Cherubino DI LORENZO

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Pierelli, MD

Role: STUDY_CHAIR

University of Roma La Sapienza

Locations

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Policlinico Umberto I

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Cherubino Di Lorenzo, PhD

Role: CONTACT

Phone: +393286783246

Email: [email protected]

Gianluca Coppola, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Cherubino Di Lorenzo, MD, PhD

Role: primary

Francesco Pierelli, MD

Role: backup

Other Identifiers

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ParMig Study

Identifier Type: -

Identifier Source: org_study_id