Fatigue in Sarcoidosis - Treatment With Methylphenidate

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for clinically-significant fatigue in sarcoidosis patients with stable disease. The primary outcomes are feasibility, aimed at determining factors that will influence the design a future, larger RCT, which will be powered to look at clinical efficacy of the intervention.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of East Anglia
• Collaborator: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
• Treatments: Methylphenidate

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.