Effect of Acetyl-L-carnitine in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Acetyl-L-carnitine
Intervention type(s): Drug
Intervention description(s): Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Other intervention name(s): ALCAR
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Preventive medication