Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis (ParMig)
Primary Purpose
Migraine Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PACR
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders
Eligibility 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.
Sites / Locations
- Policlinico Umberto IRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Migraineurs (verum)
Migranineurs (placebo)
Arm Description
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.
One pill per day of placebo: Cellulose
Outcomes
Primary Outcome Measures
Migraine improvement in terms of responder rate
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
reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.
Full Information
NCT ID
NCT03190044
First Posted
June 6, 2017
Last Updated
December 9, 2018
Sponsor
University of Roma La Sapienza
Collaborators
Gianluca Coppola, Francesco Pierelli
1. Study Identification
Unique Protocol Identification Number
NCT03190044
Brief Title
Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
Collaborators
Gianluca Coppola, Francesco Pierelli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Placebo and 'verum' pills have the similar shape and colour.
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Migraineurs (verum)
Arm Type
Experimental
Arm Description
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.
Arm Title
Migranineurs (placebo)
Arm Type
Placebo Comparator
Arm Description
One pill per day of placebo: Cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
PACR
Intervention Description
Daily assumption of PACR for a 3-month period
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily assumption of placebo
Primary Outcome Measure Information:
Title
Migraine improvement in terms of responder rate
Description
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Migraine improvement in terms of frequencies
Description
reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cherubino Di Lorenzo, PhD
Phone
+393286783246
Email
cherubino.dilorenzo@uniroma1.it
First Name & Middle Initial & Last Name or Official Title & Degree
Gianluca Coppola, PhD
Email
gianluca.coppola@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Pierelli, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Chair
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherubino Di Lorenzo, MD, PhD
Phone
+393286783246
Email
cherubino.dilorenzo@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Francesco Pierelli, MD
Email
francesco.pierelli@uniroma1.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis
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