Status:

COMPLETED

The Efficacy of L-cysteine in Prevention of Cluster Headache

Lead Sponsor:

Biohit Oyj

Collaborating Sponsors:

The Finnish Funding Agency for Technology and Innovation (TEKES)

Conditions:

Cluster Headache

Eligibility:

All Genders

18-65 years

Phase:

NA

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 c...

Detailed Description

Background: Cluster headache belongs to a group of idiopathic headache entities, the trigeminal autonomic cephalalgias (TACs), all of which involve short-lasting, unilateral, severe headache attacks a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 17 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 14 2020

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02310828

Start Date

December 17 2013

End Date

October 14 2020

Last Update

February 17 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Terveystalo, Kamppi

Helsinki, Finland, 00100

2

Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy

Helsinki, Finland, 00930

3

Terveystalo, Jyväskylä

Jyväskylä, Finland, 40100

4

Terveystalo, Oulu

Oulu, Finland, 90100