Effect of Acetyl-L-carnitine in Migraine

NCT01695317 | Completed Phase 4 Results DMC

• 1 other identifier: 2012-001624-36
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Migraine

Keywords

Migraine; Preventive medication

Outcome Measures

Primary Outcomes (1)

• 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.

  last 4 weeks

Secondary Outcomes (1)

• Days With Migraine and Side Effects

  Last 4 weeks

Study Arms (2)

Acetyl-L-carnitine

ACTIVE COMPARATOR

Acetyl-L-carnitine tablets

Drug: Acetyl-L-carnitine

Sugar pills

PLACEBO COMPARATOR

Glucose with lemon acid

Drug: Acetyl-L-carnitine

Interventions

Acetyl-L-carnitine DRUG

Week 1: 500 mg x 3, Week 2-12: 500 mg x 6

Also known as: ALCAR

Acetyl-L-carnitine; Sugar pills

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Norwegian National Headache Centre

Trondheim, 7489, Norway

Location

Related Publications (1)

• 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.

  PMID: 25601916 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. knut Hagen
• Organization: St. olavs Hospital

knut.hagen@stolav.no

95401579

Study Officials

• Knut Hagen, MD, PhD

  Norwegian National Headache Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-02

Locations

NO (1)