The Efficacy of L-cysteine in Prevention of Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02310828
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : September 26, 2018
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 attacks of cluster headache.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Acetium Drug: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 Cluster Headache. Randomized Intervention Trial With a Medical Device (Acetium® Capsules)
Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Acetium
Patient will administer Acetium capsules (100mg l-cysteine) twice a day for one month
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 one month
Drug: Placebo
A placebo capsule matching Acetium for oral administration.
Other Name: Acetium capsule placebo

Primary Outcome Measures :
  1. The frequency of headache attacks per week [ Time Frame: 1 month ]
    The frequency of headache attacks per week, either during the entire treatment period or during the last treatment interval is compared with the baseline frequencies, to disclose differences between the two study 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

Inclusion Criteria:

  • 18-65 years male/female
  • episodic and chronic cluster headache
  • the subjects should report cluster headache attacks with the frequency from one every second day up to five per day. The individual attacks should last from 15 minutes to 3h.

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
  • potentially fertile and sexually active women who do not practise contraception
  • other acute or chronic pain disorders
  • severe psychiatric disease
  • infections
  • 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
  • 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 identifier (NCT number): NCT02310828

Terveystalo, Kamppi Recruiting
Helsinki, Finland, 00100
Contact: Petra Keski-Säntti, MD, PhD    00358503738938   
Principal Investigator: Petra Keski-Säntti, MD,PhD         
Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy Recruiting
Helsinki, Finland, 00930
Contact: Mikko Kallela, MD, PhD    0035840 5050559   
Contact: Marja Hassinen    0035850 5910702   
Principal Investigator: Mikko Kallela, MD, PhD         
Sub-Investigator: Markus Färkkilä, MD, PhD         
Terveystalo, Jyväskylä Terminated
Jyväskylä, Finland, 40100
Terveystalo, Oulu Recruiting
Oulu, Finland, 90100
Contact: Mikko Kärppä, MD, PhD    0035810 345 2931   
Contact: Anu Nuojua    0035840 5066576   
Principal Investigator: Mikko Kärppä, MD, PhD         
Terveystalo, Tampere Terminated
Tampere, Finland, 33100
Terveystalo, Turku Recruiting
Turku, Finland, 20100
Contact: Markku Nissilä, MD    00358400 788 020   
Contact: Sanna Hannukainen    00358505220271   
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)
Study Chair: Kari Syrjänen, MD, PhD Biohit Oyj

Responsible Party: Biohit Oyj Identifier: NCT02310828     History of Changes
Other Study ID Numbers: AC-CLUSTPREV-1
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Biohit Oyj:
Cluster headache
Migrainous neuralgia
Horton's headache
Histaminic cephalalgia

Additional relevant MeSH terms:
Cluster Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases