Effect of Acetyl-L-carnitine in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Acetyl-L-carnitine
Intervention description: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Intervention MeSH terms: Acetylcarnitine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Preventive medication

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. 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
    

Eligibility criteria:

        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.