MigraineNCT01010711
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
A study testing Migra 3 in people with Migraine, run by Complen Health GmbH at 2 sites in Germany.
Trial summary
Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Migra 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2009to Apr 2011
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- at least 3 days of migraine per month
Who cannot join
- not able to communicate in german or english language
- any disease that forbids the participation in the trial according to the investigators assessment
- pregnancy
- no willingness to participate in the trial
- known allergy to fish or soya
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,
Essen, North Rhine-Westphalia, D-45147
Charly Gaul, MD, 0049-201-43696-0, Charly.Gaul@gmx.de
Dagny Holle, MD
- Recruiting
Migräne und Kopfschmerzklinik Königstein
Königstein im Taunus, 61462
Dr. Jan Brand, Dr., 0049-6174-29040, info@migraene-klinik.de
About this study
Official title: Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Read the detailed description
Children or adolescents with migraine and both parents are informed in detail about the study.Probands are advised to fill in a special childrens´ diary for migraine daily. After a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. Afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.
- Conditions
- Migraine
- Being tested
- Migra 3
- Keywords
- migraine, children, dietary supplement, q10, prevention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migra 3Dietary supplement
powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements
| Study group | Role | What they receive |
|---|---|---|
| migraine dietary supplement | Other | the average days of migraine during a 4 week-run-in-period are compared with the average days of migraine during intervention with a "specific dietary supplement" from week 8 - 12 Receives: Dietary Supplement: Migra 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
Measured: headaches before and after 12 weeks of treatment
Secondary outcomes (1)
frequency, duration and intensity of the migraine
Measured: before and after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complen Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charly Gaul, MD, Principal investigator, Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010711
- Sponsor's protocol ID
- TOM-DS-CH-1
- Status last verified
- Feb 2010
- First submitted
- 9 Nov 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01010711
- Acronym / sponsor ID
- TOM-DS-CH-1
- Conditions
- Migraine
- Keywords
- migraine, children, dietary supplement, q10, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Complen Health GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 10 Nov 2009 (estimated)
- 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 in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Detailed description
Children or adolescents with migraine and both parents are informed in detail about the study.Probands are advised to fill in a special childrens´ diary for migraine daily. After a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. Afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| migraine dietary supplement | Other | Dietary Supplement: Migra 3the average days of migraine during a 4 week-run-in-period are compared with the average days of migraine during intervention with a "specific dietary supplement" from week 8 - 12 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- at least 3 days of migraine per month
Key exclusion criteria (5 listed)
- not able to communicate in german or english language
- any disease that forbids the participation in the trial according to the investigators assessment
- pregnancy
- no willingness to participate in the trial
- known allergy to fish or soya
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 |
|---|---|---|
| Migra 3powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements | Dietary supplement | migraine dietary supplement |
Primary outcome
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
Time frame: headaches before and after 12 weeks of treatment
1 secondary outcome
frequency, duration and intensity of the migraine
Time frame: before and after 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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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.
Charly Gaul, MD principal investigator
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migra 3 in people with Migraine, run by Complen Health GmbH at 2 sites in Germany.
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 1 inclusion and 5 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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 Charly Gaul, MD (0049-201-43696-0, Charly.Gaul@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement (time frame: headaches before and after 12 weeks of treatment). 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 2 Feb 2010.