MigrainePhase 4ALCARNCT01695317
Effect of Acetyl-L-carnitine in Migraine
A Phase 4 study testing Acetyl-L-carnitine in people with Migraine, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also antiepileptic drugs. Contraindications and side effects have to some degree limited their use, and new prophylactics that can be used by most migraine sufferers and with little side effects are in demand. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Acetyl-L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2013to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 to 65 years
- Signed informed consent
- Migraine with or without aura according to International Classification of Headache Disorders, second version (ICHD-2) criteria
- chronic migraine according to the ICHD-2 criteria (revision 1)
- Retrospectively have 2 or more migraine attacks per month during the last 3 month
- During the baseline period have 2 or more migraine attacks
Show all 10Show fewer
- Debut of migraine at least one year prior to inclusion
- Start of migraine before age 50 years
- Body mass index (BMI )between 18-35 kg/m2
- No medication overuse during the last 3 months defined as headache >14 days/month combined with overuse simple analgesics >14 days/month or triptans or combined medications ≥ 10 days/month.
Who cannot join
- Interval headache not distinguishable from migraine
- Chronic tension-type headache or other headache than migraine occurring on ≥ 15 days/month with or without medication overuse
- Pregnancy, nursing or inability to use contraceptives
- Hypersensitivity to active substance
- History of angioneurotic edema, diabetes mellitus, significant psychiatric illness and/or Hospital anxiety and Depression Scale( HADS) anxiety score ≥ 11 or HADS depression score ≥ 11, and/or use of selective serotonin reuptake inhibitors (SSRI), antipsychotic medication, or antidepressant medication during the last 3 months
- Use of daily migraine prophylactics less than 3 months prior to start of study
Show all 13Show fewer
- Previous use of Acetyl-L-carnitine
- BMI <18 kg/m2 or BMI > 35 kg/m2
- Having tried ≥ 3 prophylactic drugs against migraine during the last 5 years
- Subjects requiring detoxification from acute medication
- Patients who consistently fail to respond to any acute migraine medication
- Patients with alcohol or illicit drug dependence; 13) Subjects with renal disease or decreased renal function
- Previous or present history of asthma or vascular disease, arterial claudication included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acetyl-L-carnitine in Migraine - a Randomized, Double-blind Placebo Controlled Study
Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also antiepileptic drugs. Contraindications and side effects have to some degree limited their use, and new prophylactics that can be used by most migraine sufferers and with little side effects are in demand. One product that may seem to fulfill these requirements is Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and animals. L-carnitine is necessary for fatty-acid metabolism and energy production.
To our knowledge, no placebo-controlled studies have previously evaluated the efficacy of Acetyl-L-carnitine in adults with migraine.
The aims of the present study is to evaluate the efficacy of Acetyl-L-carnitine as a prophylaxis in migraine patients
Read the detailed description
The study will be a single-centre double-blinded, randomized, placebo controlled crossover study with Acetyl-L-carnitine or placebo. We plan to include 72 patients. The follow up duration will be 36 weeks. The study will be performed according to Good Clinical Practice, and relying partly on the International Headache Society Guidelines for controlled trials of drugs in migraine from 2012 and partly on the guidelines divulged by the International Headache Society task force on trial guidelines for chronic migraine.
After a screening visit including a neurological consultation, eligible patients will sign an informed consent declaration before they enter a 4 week run-in (baseline) period when they keep a headache diary. After 4 weeks they return for the second visit. If they have had 2 or more migraine attacks they are allowed to proceed in the study. If they have less than 2 migraine attacks (required for proceeding in the study), they are allowed to extend the baseline period another 4 weeks. Those who then during the whole 8 week period have on average 2 or more migraine attacks per month are also allowed to proceed. Otherwise they are excluded from the study.
Details of the treatment period The duration of each of the two treatment periods is 12 weeks. During each period there will be one telephone contact at the start of each treatment period to remind patients to start with medicines, and one after 2 weeks to check compliance and side effects. In the second last week of every treatment period there will be a doctor and nurse visit with drug accounting and dispensing of new medicines for the next period. At this visit one will ensure that the patient has just enough medicines left to finish the period before the wash-out. As recommended in crossover studies, the participants enter a washout period of 4 weeks between the two treatment periods, to reduce the risk of carryover effect.
Randomization Randomization will be generated using a computerized procedure. A randomization list containing 72 patient numbers is made before the start of the study, and the patient number is then indicated on a package with medicines for that patient. The study has a crossover design, and the two different treatment periods (active or placebo) can arise to two different treatment sequences (AP or PA). Patients are therefore randomized in blocks of 4 where one of these two treatment sequences is assigned to each patient in random order. With 72 patients to be included, this means that 18 patients are randomized in each block. In each block, 50% patients have the treatment sequence AP, and 50% PA in a random order.
- Conditions
- Migraine
- Being tested
- Acetyl-L-carnitine
- Keywords
- Migraine, Preventive medication
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-carnitineDrug
Also called ALCAR
Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
| Study group | Role | What they receive |
|---|---|---|
| Acetyl-L-carnitine | Active comparator | Acetyl-L-carnitine tablets Receives: Drug: Acetyl-L-carnitine |
| Sugar pills | Placebo comparator | Glucose with lemon acid Receives: Drug: Acetyl-L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or if treated with the patient's usual headache medication (usually a triptan) as the primary endpoint.
Measured: last 4 weeks
Secondary outcomes (1)
Days With Migraine and Side Effects
Secondary measures will be: Days with migraine; days with headache; hours with headache; headache intensity (0-3 scale) on days with headache; doses of analgesics; doses of triptans; days with sick leave; number of responders (≥ 50% decrease in migraine days compared with baseline); incidence of side effects recorded openly.
Measured: Last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Knut Hagen, MD, PhD, Principal investigator, Norwegian National Headache Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695317
- Sponsor's protocol ID
- 2012-001624-36
- Acronym
- ALCAR
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2012
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hagen K, Brenner E, Linde M, Gravdahl GB, Tronvik EA, Engstrom M, Sonnewald U, Helde G, Stovner LJ, Sand T. Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study. Cephalalgia. 2015 Oct;35(11):987-95. doi: 10.1177/0333102414566817. Epub 2015 Jan 19.
PubMed 25601916
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetyl-L-carnitine in Migraine - a Randomized, Double-blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01695317
- Acronym / sponsor ID
- ALCAR / 2012-001624-36
- Conditions
- Migraine
- Keywords
- Migraine, Preventive medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Posted 13 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also antiepileptic drugs. Contraindications and side effects have to some degree limited their use, and new prophylactics that can be used by most migraine sufferers and with little side effects are in demand. One product that may seem to fulfill these requirements is Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and animals. L-carnitine is necessary for fatty-acid metabolism and energy production.
To our knowledge, no placebo-controlled studies have previously evaluated the efficacy of Acetyl-L-carnitine in adults with migraine.
The aims of the present study is to evaluate the efficacy of Acetyl-L-carnitine as a prophylaxis in migraine patients
Detailed description
The study will be a single-centre double-blinded, randomized, placebo controlled crossover study with Acetyl-L-carnitine or placebo. We plan to include 72 patients. The follow up duration will be 36 weeks. The study will be performed according to Good Clinical Practice, and relying partly on the International Headache Society Guidelines for controlled trials of drugs in migraine from 2012 and partly on the guidelines divulged by the International Headache Society task force on trial guidelines for chronic migraine.
After a screening visit including a neurological consultation, eligible patients will sign an informed consent declaration before they enter a 4 week run-in (baseline) period when they keep a headache diary. After 4 weeks they return for the second visit. If they have had 2 or more migraine attacks they are allowed to proceed in the study. If they have less than 2 migraine attacks (required for proceeding in the study), they are allowed to extend the baseline period another 4 weeks. Those who then during the whole 8 week period have on average 2 or more migraine attacks per month are also allowed to proceed. Otherwise they are excluded from the study.
Details of the treatment period The duration of each of the two treatment periods is 12 weeks. During each period there will be one telephone contact at the start of each treatment period to remind patients to start with medicines, and one after 2 weeks to check compliance and side effects. In the second last week of every treatment period there will be a doctor and nurse visit with drug accounting and dispensing of new medicines for the next period. At this visit one will ensure that the patient has just enough medicines left to finish the period before the wash-out. As recommended in crossover studies, the participants enter a washout period of 4 weeks between the two treatment periods, to reduce the risk of carryover effect.
Randomization Randomization will be generated using a computerized procedure. A randomization list containing 72 patient numbers is made before the start of the study, and the patient number is then indicated on a package with medicines for that patient. The study has a crossover design, and the two different treatment periods (active or placebo) can arise to two different treatment sequences (AP or PA). Patients are therefore randomized in blocks of 4 where one of these two treatment sequences is assigned to each patient in random order. With 72 patients to be included, this means that 18 patients are randomized in each block. In each block, 50% patients have the treatment sequence AP, and 50% PA in a random order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-L-carnitine | Active comparator | Drug: Acetyl-L-carnitineAcetyl-L-carnitine tablets |
| Sugar pills | Placebo comparator | Drug: Acetyl-L-carnitineGlucose with lemon acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 65 years
- Signed informed consent
- Migraine with or without aura according to International Classification of Headache Disorders, second version (ICHD-2) criteria
- chronic migraine according to the ICHD-2 criteria (revision 1)
- Retrospectively have 2 or more migraine attacks per month during the last 3 month
Key exclusion criteria (13 listed)
- Interval headache not distinguishable from migraine
- Chronic tension-type headache or other headache than migraine occurring on ≥ 15 days/month with or without medication overuse
- Pregnancy, nursing or inability to use contraceptives
- Hypersensitivity to active substance
- History of angioneurotic edema, diabetes mellitus, significant psychiatric illness and/or Hospital anxiety and Depression Scale( HADS) anxiety score ≥ 11 or HADS depression score ≥ 11, and/or use of selective serotonin reuptake inhibitors (SSRI), antipsychotic medication, or antidepressant medication during the last 3 months
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 |
|---|---|---|
| Acetyl-L-carnitineAlso: ALCARWeek 1: 500 mg x 3, Week 2-12: 500 mg x 6 | Drug | Acetyl-L-carnitine, Sugar pills |
Primary outcome
Headache Days
Time frame: last 4 weeks
The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or if treated with the patient's usual headache medication (usually a triptan) as the primary endpoint.
1 secondary outcome
Days With Migraine and Side Effects
Time frame: Last 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25601916Hagen K, Brenner E, Linde M, Gravdahl GB, Tronvik EA, Engstrom M, Sonnewald U, Helde G, Stovner LJ, Sand T. Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study. Cephalalgia. 2015 Oct;35(11):987-95. doi: 10.1177/0333102414566817. Epub 2015 Jan 19.
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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.
Knut Hagen, MD, PhD principal investigator
Norwegian National Headache Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetyl-L-carnitine in people with Migraine, run by Norwegian University of Science and Technology at 1 site in Norway.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 13 Apr 2022. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: last 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695317, which also lists 1 linked publication.
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 13 Apr 2022.