Effect of Acetyl-L-carnitine in Migraine (ALCAR)

February 15, 2022 updated by: Norwegian University of Science and Technology

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7489
        • Norwegian National Headache Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetyl-L-carnitine
Acetyl-L-carnitine tablets
Drug: Acetyl-L-carnitine
Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Other Names:
  • ALCAR
Placebo Comparator: Sugar pills
Glucose with lemon acid
Drug: Acetyl-L-carnitine
Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Other Names:
  • ALCAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
last 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days With Migraine and Side Effects
Time Frame: Last 4 weeks
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.
Last 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Knut Hagen, MD, PhD, Norwegian National Headache Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-001624-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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