The Efficacy of L-cysteine in Prevention of Headache Attacks in Migraine Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT02315833
• Date of registration: 04/12/2014
• Prospective Registration: No
• Primary sponsor: Biohit Oyj
• Public title: The Efficacy of L-cysteine in Prevention of Headache Attacks in Migraine Patients
• Scientific title: The Efficacy of L-cysteine in Prevention of Headache Attacks in Migraine Patients. Randomized Intervention Trial With a Medical Device (Acetium®Capsules)
• Date of first enrolment: December 17, 2013
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02315833
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Estonia, Finland

Contacts

• Name: Kari Syrjänen, MD, PhD
• Affiliation: Biohit Oyj

• Name: Mikko Kallela, MD, PhD
• Affiliation: Helsingin Päänsärkykeskus Oy

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18-65 years male/female

- subjects should report migraine attacks with the frequency of 2-8 times per month, and
with less than 15 migraine days (NMD) per month. To be calculated as a separate
attack, there should be at least 48h of freedom from headache between the two attacks
of migraine.

- migraine with or without aura has been present for at least 1 year prior to entering
into the study

- subjects to be enrolled should report the onset of their migraine before 50 years of
age

Exclusion Criteria:

- patients who meet the International Classification of Headache Disorders II criteria
for medication overuse

- patients who have taken anti-psychotics or anti-depressant medications during the
previous 3 months

- patients who abuse alcohol or other drugs

- patients resistant to all acute migraine drugs optimally prescribed

- potentially fertile and sexually active women who do not practise contraception

- other acute or chronic pain disorders

- severe psychiatric disease

- infection

- malignancy

- short life expectancy

- cardiovascular disease

- cerebrovascular disease

- uncontrolled hypertension

- degenerative central nervous system diseases

- pregnant and lactating women

- regular users of Acetium capsules for other indications

- persons suffering from renal dysfunction or cystinuria



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Migraine

Intervention(s)

Drug: Placebo

Drug: Acetium

Primary Outcome(s)

Number of migraine attacks (NMA) per evaluation interval [Time Frame: 3 months]

Secondary Outcome(s)

Number of migraine days (NMD) per evaluation period [Time Frame: 3 months]

Secondary ID(s)

AC-MIGPREV-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Finnish Funding Agency for Technology and Innovation (TEKES)