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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
NCT02310828 |
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Date of registration:
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04/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Efficacy of L-cysteine in Prevention of Cluster Headache
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Scientific title:
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The Efficacy of L-cysteine in Prevention of Cluster Headache. Randomized Intervention Trial With a Medical Device (Acetium® Capsules) |
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Date of first enrolment:
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December 17, 2013 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02310828 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Mikko Kallela, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki Headache Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cluster Headache
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Intervention(s)
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Drug: Placebo
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Drug: Acetium
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Primary Outcome(s)
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The frequency of headache attacks per week
[Time Frame: 1 month]
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Secondary ID(s)
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AC-CLUSTPREV-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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