Effect of Acetyl-L-carnitine in Migraine

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Treatments: Acetylcarnitine

Criteria

Inclusion Criteria:

• Age 18 to 65 years

• Signed informed consent

• Migraine with or without aura according to 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

• 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 HADS anxiety score ≥ 11 or HADS depression score ≥ 11, and/or use of 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.