NCT02310828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

5.1 years

First QC Date

December 4, 2014

Last Update Submit

February 16, 2021

Conditions

Cluster Headache

Keywords

Cluster headacheMigrainous neuralgiaHorton's headacheHistaminic cephalalgia

Outcome Measures

Primary Outcomes (1)

  • The frequency of headache attacks per week

    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.

    1 month

Study Arms (2)

Acetium

EXPERIMENTAL

Patient will administer Acetium capsules (100mg l-cysteine) twice a day for one month

Drug: Acetium

Placebo

PLACEBO COMPARATOR

Patient will administer placebo capsules twice a day for one month

Drug: Placebo

Interventions

AcetiumDRUG

Capsule for oral administration contains L-cysteine 100mg

Also known as: Acetium capsule
Acetium
PlaceboDRUG

A placebo capsule matching Acetium for oral administration.

Also known as: Acetium capsule placebo
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Terveystalo, Kamppi

Helsinki, 00100, Finland

Location

Lääkärikeskus Aava, Helsingin Päänsärkykeskus Oy

Helsinki, 00930, Finland

Location

Terveystalo, Jyväskylä

Jyväskylä, 40100, Finland

Location

Terveystalo, Oulu

Oulu, 90100, Finland

Location

Terveystalo, Tampere

Tampere, 33100, Finland

Location

Terveystalo, Turku

Turku, 20100, Finland

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mikko Kallela, MD, PhD

    Helsinki Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

December 17, 2013

Primary Completion

February 8, 2019

Study Completion

October 14, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(6)