Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02643732
Eligibility Criteria:
Inclusion Criteria:
1. Biopsy-proven diagnosis of sarcoidosis or diagnosis of sarcoidosis from interstitial lung disease multidisciplinary team meeting after review of radiological and clinical information
2. Stable disease (treatment unchanged for 6 weeks, without anticipation of treatment change during trial period)
3. FAS score greater than 21 units
4. Able to give informed consent
5. In patients on warfarin therapy - Willing to consent to increased frequency of monitoring
Exclusion Criteria:
1. Evidence of co-existing obstructive sleep apnoea. Patients screened with a "STOP-Bang" questionnaire (acronym taken from individual questions within the questionnaire itself) score of greater than 4 must undertake overnight oximetry; they are excluded if this shows a desaturation index of more than 15 events per hour on overnight oximetry.
2. Documented history of significant cardiac disease (including cardiac sarcoid) OR associated disease which would increase risk of underlying coronary artery disease (cerebrovascular disease, previous stroke or peripheral vascular disease). Definitively treated cardiac disease e.g. previous myocardial infarction treated with stents or coronary artery bypass grafting with no ongoing symptoms is permitted.
3. Hyperthyroidism evidenced by abnormal screening thyroid function tests (Thyroid stimulating hormone level outside normal range of 0.35 - 3.50 milliunits/litre (mU/L) or thyroxine (T4) outside normal range of 8 - 21 picomoles per litre (pmol/L)).
4. History of seizures, excluding febrile convulsions whilst an infant.
5. Abnormal electrocardiogram (ECG) with evidence of arrhythmia (except first degree heart block which has been stable for 3 months).
6. Concomitant therapy with the following drugs:
* Tricyclic antidepressants
* Monoamine oxidase inhibitors
* Tramadol or buprenorphine
* Levodopa
* Haloperidol and atypical antipsychotics
7. Glaucoma or raised intra-ocular pressure for any reason.
8. Patients with established liver disease defined as Child-Pugh class B or C.
9. Documented medical history of psychiatric disorders (excluding depression)
10. History of drug-dependence or addiction at any time
11. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
12. Female patient of childbearing potential unable or unwilling to take two acceptable forms of contraception (see exclusions section)
13. Receiving an investigational drug or biological agent within 6 weeks (or 5 times the half-life if this is longer) prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02643732
Study Brief:
Protocol Section:
NCT02643732