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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Biohit Oyj
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Biohit Oyj
ClinicalTrials.gov Identifier:
NCT02315833
First received: December 4, 2014
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort) the headache attacks in migraine patients.

Condition Intervention
Migraine
Drug: Acetium
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of L-cysteine in Prevention of Headache Attacks in Migraine Patients. Randomized Intervention Trial With a Medical Device (Acetium®Capsules)

Resource links provided by NLM:


Further study details as provided by Biohit Oyj:

Primary Outcome Measures:
  • Number of migraine attacks (NMA) per evaluation interval [ Time Frame: 3 months ]
    The frequency of headache attacks during the entire treatment period (3 months) is compared with the baseline frequencies, to disclose the differences in efficacy measures between the two arms.


Secondary Outcome Measures:
  • Number of migraine days (NMD) per evaluation period [ Time Frame: 3 months ]
    The frequency of headache days during the entire treatment period (3 months) is compared with the baseline frequencies, to disclose the differences in efficacy measures between the two arms.


Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetium
Patient will administer Acetium capsules (100mg l-cysteine) twice a day for three months
Drug: Acetium
Capsule for oral administration contains L-cysteine 100mg
Placebo Comparator: Placebo
Patient will administer placebo capsules twice a day for three months
Drug: Placebo
A placebo capsule matching Acetium for oral administration.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02315833

Locations
Finland
Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy Recruiting
Helsinki, Finland, 00100
Contact: Mikko Kallela, MD, PhD    0035850 5910702    mikko.kallela@pp.fimnet.fi   
Contact: Anne Nyrhinen    0035850 5910702    anne.nyrhinen@aava.fi   
Principal Investigator: Mikko Kallela, MD, PhD         
Sub-Investigator: Markus Färkkilä, MD, PhD         
Terveystalo, Kamppi Recruiting
Helsinki, Finland, 00100
Contact: Petra Keski-Säntti, MD, PhD    00358503738938    petra.keski-santti@terveystalo.com   
Principal Investigator: Petra Keski-Säntti, MD,PhD         
Terveystalo, Jyväskylä Recruiting
Jyväskylä, Finland, 40100
Contact: Matti Ilmavirta, MD, PhD    0035850-5631802    Matti.ilmavirta@terveystalo.com   
Contact: Anna Kinnunen    0035850-5631802    Anna.Kinnunen@terveystalo.com   
Principal Investigator: Matti Ilmavirta, MD, PhD         
Terveystalo, Oulu Recruiting
Oulu, Finland, 90101
Contact: Mikko Kärppä, MD, PhD    0035810 345 2931    mikko.karppa@oulu.fi   
Contact: Jaana Vainionpää    0035810 345 2931    jaana.vainionpaa@terveystalo.com   
Principal Investigator: Mikko Kärppä, MD, PhD         
Terveystalo, Turku Recruiting
Turku, Finland, 20100
Contact: Markku Nissilä, MD    00358400 788 020    markku.nissila@terveystalo.com   
Contact: Sanna Hannukainen    00358505220271    sanna.hannukainen@terveystalo.com   
Principal Investigator: Markku Nissilä, MD         
Sub-Investigator: Nina Suvanto-Collán, MD         
Sponsors and Collaborators
Biohit Oyj
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Study Chair: Kari Syrjänen, MD, PhD Biohit Oyj
Principal Investigator: Mikko Kallela, MD, PhD Helsingin Päänsärkykeskus Oy
  More Information

Responsible Party: Biohit Oyj
ClinicalTrials.gov Identifier: NCT02315833     History of Changes
Other Study ID Numbers: AC-MIGPREV-1
Study First Received: December 4, 2014
Last Updated: January 20, 2016

Keywords provided by Biohit Oyj:
Migraine
Aura

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017