Fatigue and Sarcoidosis: Treatment with Methylphenidate

Phase 1

• Conditions: Sarcoidosis-associated fatigue (Patients with stable sarcoidosis and chronic fatigue); MedDRA version: 20.1 Level: PT Classification code 10039486 Term: Sarcoidosis System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000342-60-GB
• Lead Sponsor: orfolk and Norwich University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.A proven diagnosis of sarcoidosis – this is defined as either a biopsy-proven disease (non-caseating granulomas from a tissue biopsy), or a diagnosis of sarcoidosis agreed by an interstitial lung disease multidisciplinary team (ILD MDT) meeting.
2.Stable disease (treatment unchanged for 6 weeks, without anticipation of change in treatment during trial period)
3.Able to give informed consent.
4.Fatigue Assessment Sscale (FAS) score greater than 21 units (defined cut off for significant fatigue present)
5.In patients on warfarin therapy – Willing to consent to increased frequency of monitoring
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Evidence of co-existing obstructive sleep apnoea. Patients screened with a STOP-Bang” questionnaire score of greater than 4 must undertake overnight oximetry; they are only excluded if this shows a desaturation index of more than 15 events per hour on overnight oximetry. Below this participants are eligible for inclusion.
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 (TSH outside normal range of 0.35 – 3.50 mU/L or T4 outside normal range of 8 – 21 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:
a.Tricyclic antidepressants
b.Monoamine oxidase inhibitors
c.Tramadol or buprenorphine
d.Levodopa
e.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 below)
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.

Exclusion criteria on pregnancy
Female patients of childbearing potential and unable or unwilling to take two of the following acceptable methods of contraception for the duration of their treatment will be excluded from participating in this trial:
•Established use of oral, injected or implanted hormonal methods of contraception
•Barrier methods of contraception (condom or occlusive cap with spermicide – please note, use of spermicide without a form of barrier contraception is not an acceptable form of contraception)
•Absolute and continuous abstinence. Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation) or withdrawal are not acceptable methods of contraception

For the purposes of this trial the definition of a woman of childbearing potential is a sexually mature woman (i.e. has experienced menstruation) who has not been postmenopausal for 12 consecutive months (i.e. who has had menses at any time in the last 12 months without an alternative medical cause).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified