Migraine DisordersParMigNCT03190044
Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis
A study testing PACR in people with Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- PACR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gianluca Coppola, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Umberto I
Rome, 00161
Cherubino Di Lorenzo, MD, PhD, +393286783246, cherubino.dilorenzo@uniroma1.it
Francesco Pierelli, MD, francesco.pierelli@uniroma1.it
About this study
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)
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
- Being tested
- PACR, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACRDietary supplement
Daily assumption of PACR for a 3-month period
PlaceboDietary supplement
Daily assumption of placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: PACR |
| Migranineurs (placebo) | Placebo comparator | One pill per day of placebo: Cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine improvement in terms of responder rate
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
Measured: 3 months
Secondary outcomes (1)
Migraine improvement in terms of frequencies
reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start6 Jun 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Gianluca Coppola, Francesco Pierelli
- Responsible party
- Principal investigator, Cherubino DI LORENZO, University of Roma La Sapienza
- Investigators
- Francesco Pierelli, MD, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190044
- Sponsor's protocol ID
- ParMig Study
- Acronym
- ParMig
- Status last verified
- Dec 2018
- First submitted
- 6 Jun 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03190044
- Acronym / sponsor ID
- ParMig / ParMig Study
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Gianluca Coppola, Francesco Pierelli
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraineurs (verum) | Experimental | Dietary Supplement: PACROne 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. |
| Migranineurs (placebo) | Placebo comparator | Dietary Supplement: PlaceboOne pill per day of placebo: Cellulose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACRDaily assumption of PACR for a 3-month period | Dietary supplement | Migraineurs (verum) |
| PlaceboDaily assumption of placebo | Dietary supplement | Migranineurs (placebo) |
Primary outcome
Migraine improvement in terms of responder rate
Time frame: 3 months
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
1 secondary outcome
Migraine improvement in terms of frequencies
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Coppola, PhD contact
Francesco Pierelli, MD study chair
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACR in people with Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherubino Di Lorenzo, PhD (+393286783246, cherubino.dilorenzo@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine improvement in terms of responder rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.