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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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16 December 2017 |
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Main ID: |
NCT02643732 |
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Date of registration:
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23/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fatigue in Sarcoidosis - Treatment With Methylphenidate
FaST-MP |
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Scientific title:
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Fatigue in Sarcoidosis - A Feasibility Study Investigating the Treatment of Fatigue in Stable Sarcoidosis Patients Using Methylphenidate |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02643732 |
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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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United Kingdom
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Contacts
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Name:
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Marcus Flather, MB/BS |
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Address:
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Telephone:
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Email:
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marcus.flather@nnuh.nhs.uk |
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Affiliation:
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Name:
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Chris Atkins, MBBS |
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Address:
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Telephone:
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01603 591594 |
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Email:
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c.atkins@uea.ac.uk |
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Affiliation:
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Name:
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Andrew M Wilson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of East Anglia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fatigue
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Sarcoidosis
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Intervention(s)
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Drug: Placebo (Over-encapsulated tablet)
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Drug: Methylphenidate (overencapsulated)
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Primary Outcome(s)
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Number of accelerometers returned with valid data (Feasibility outcome)
[Time Frame: 24 weeks (trial duration)]
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Number of missed or unfilled assessments (Feasibility outcome)
[Time Frame: 24 weeks (trial duration)]
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Number of potential participants excluded (Feasibility outcome)
[Time Frame: Up to 18 months (recruitment period duration)]
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Number of participants dropping out/Participant retention rate (Feasibility outcome)
[Time Frame: 24 weeks (trial duration)]
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Recruitment rate (Feasibility outcome)
[Time Frame: Up to 18 months (recruitment period duration)]
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Side-effect rate (Feasibility and Safety outcome)
[Time Frame: 24 weeks (trial duration)]
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Secondary Outcome(s)
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EuroQoL-5D (EQ5D) Questionnaire
[Time Frame: 0,6,12,18,14 and 30 weeks]
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Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
[Time Frame: 0,2,4,6,12,18,14 and 30 weeks]
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Fatigue Assessment Scale (FAS) (Clinical outcome)
[Time Frame: 0,2,4,6,12,18,14 and 30 weeks]
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Modified Shuttle Walk Test (MSWT)
[Time Frame: 0, 12, 24 weeks]
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Short-form 36 (SF-36) Questionnaire
[Time Frame: 0,6,12,18,14 and 30 weeks]
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Hospital Anxiety and Depressions Score (HADS)
[Time Frame: 0,6,12,18,14 and 30 weeks]
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Accelerometer Use (wrist-worn accelerometer)
[Time Frame: 0, 12, 24 weeks]
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Kings Sarcoidosis Questionnaire (KSQ)
[Time Frame: 0,6,12,18,14 and 30 weeks]
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Secondary ID(s)
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170-11-15
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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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