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The Efficacy of L-cysteine in Prevention of Cluster Headache

This study is currently recruiting participants.
Verified June 2017 by Biohit Oyj
Sponsor:
ClinicalTrials.gov Identifier:
NCT02310828
First Posted: December 8, 2014
Last Update Posted: June 23, 2017
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.
Collaborator:
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Biohit Oyj
  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 attacks of cluster headache.

Condition Intervention
Cluster Headache Drug: Acetium Drug: Placebo

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Biohit Oyj:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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 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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  • 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
  Contacts and Locations
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): NCT02310828


Locations
Finland
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         
Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy Recruiting
Helsinki, Finland, 00930
Contact: Mikko Kallela, MD, PhD    0035840 5050559    mikko.kallela@pp.fimnet.fi   
Contact: Eerika Kujansuu    0035850 5910702    eerikakujansuu.tutkimushoitaja@gmail.com   
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    mikko.karppa@oulu.fi   
Contact: Anu Nuojua    0035840 5066576    anu.nuojua@trialcoordinators.com   
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    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
  More Information

Responsible Party: Biohit Oyj
ClinicalTrials.gov Identifier: NCT02310828     History of Changes
Other Study ID Numbers: AC-CLUSTPREV-1
First Submitted: December 4, 2014
First Posted: December 8, 2014
Last Update Posted: June 23, 2017
Last Verified: June 2017
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:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases