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Trial record 1 of 1 for:    NCT02310828
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The Efficacy of L-cysteine in Prevention of Cluster Headache

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ClinicalTrials.gov Identifier: NCT02310828
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : February 17, 2021
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 attacks of cluster headache.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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)
Actual Study Start Date : December 17, 2013
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : October 14, 2020

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.



Information from the National Library of Medicine

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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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02310828


Locations
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Finland
Terveystalo, Kamppi
Helsinki, Finland, 00100
Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy
Helsinki, Finland, 00930
Terveystalo, Jyväskylä
Jyväskylä, Finland, 40100
Terveystalo, Oulu
Oulu, Finland, 90100
Terveystalo, Tampere
Tampere, Finland, 33100
Terveystalo, Turku
Turku, Finland, 20100
Sponsors and Collaborators
Biohit Oyj
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
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Principal Investigator: Mikko Kallela, MD, PhD Helsinki Headache Center
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Responsible Party: Biohit Oyj
ClinicalTrials.gov Identifier: NCT02310828    
Other Study ID Numbers: AC-CLUSTPREV-1
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
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:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases