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

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ClinicalTrials.gov Identifier: NCT02315833
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : September 24, 2018
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Biohit Oyj

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Drug: Acetium Drug: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : June 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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
Other Name: Acetium capsule

Placebo Comparator: Placebo
Patient will administer placebo capsules twice a day for three months
Drug: Placebo
A placebo capsule matching Acetium for oral administration.
Other Name: Acetium capsule placebo




Primary Outcome Measures :
  1. 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 :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315833


Locations
Estonia
Confido Privat Medical Clinic Recruiting
Tallinn, Estonia, 11313
Contact: Toomas Toomsoo, PhD    00372 522 8332    Toomas.Toomsoo@itk.ee   
Contact: Marko Ölluk, MD    00372 505 3420    Marko.Olluk@confido.ee   
Principal Investigator: Toomas Toomsoo, PhD         
Sub-Investigator: Marko Ölluk, MD         
Tartu University Hospital, Neurology Clinic Recruiting
Tartu, Estonia, 51014
Contact: Mark Braschinsky, PhD    00372 558 5711    Mark.Braschinsky@kliinikum.ee   
Contact: Kati Toom, MD       Kati.Toom@kliinikum.ee   
Principal Investigator: Mark Braschinsky, PhD         
Sub-Investigator: Kati Toom, MD         
Finland
Terveystalo, Kamppi Completed
Helsinki, Finland, 00100
Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy Completed
Helsinki, Finland, 00930
Terveystalo, Jyväskylä Terminated
Jyväskylä, Finland, 40100
Terveystalo, Oulu Completed
Oulu, Finland, 90101
Terveystalo, Turku Terminated
Turku, Finland, 20100
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

Responsible Party: Biohit Oyj
ClinicalTrials.gov Identifier: NCT02315833     History of Changes
Other Study ID Numbers: AC-MIGPREV-1
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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