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Fatigue in Sarcoidosis - Treatment With Methylphenidate (FaST-MP)

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ClinicalTrials.gov Identifier: NCT02643732
Recruitment Status : Unknown
Verified January 2017 by University of East Anglia.
Recruitment status was:  Recruiting
First Posted : December 31, 2015
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Information provided by (Responsible Party):
University of East Anglia

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Fatigue Drug: Methylphenidate (overencapsulated) Drug: Placebo (Over-encapsulated tablet) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fatigue in Sarcoidosis - A Feasibility Study Investigating the Treatment of Fatigue in Stable Sarcoidosis Patients Using Methylphenidate
Study Start Date : November 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Sarcoidosis

Arm Intervention/treatment
Experimental: Methylphenidate

Methylphenidate 10mg (one tablet) twice daily, increasing to 20mg (two tablets) twice daily following assessment 2 weeks into trial.

24 weeks duration

Drug: Methylphenidate (overencapsulated)
10mg (1 capsule) methylphenidate (standard release) twice daily, increased to 20mg (2 capsules) twice daily after 2 weeks. The drug can be down-titrated in the event of side effects, although re-uptitration is not allowed even if the side effects resolve on the lower dose.
Other Name: Tranquilyn

Placebo Comparator: Placebo

Identical, over-encapsulated placebo tablets manufactured to be identical to the experimental tablets. One tablet twice daily, increased to two tablets twice daily following assessment 2 weeks into trial.

24 weeks duration.

Drug: Placebo (Over-encapsulated tablet)
Identical capsules (over-encapsulated placebo tablets), administered initially one capsule twice daily, increased to 2 capsules after 2 weeks. As with the methylphenidate arm, the dose can be down-titrated in the event of side effects, although re-uptitration is not allowed even if the side effects resolve on the lower dose.




Primary Outcome Measures :
  1. Recruitment rate (Feasibility outcome) [ Time Frame: Up to 18 months (recruitment period duration) ]
    How quickly the 30 participants are recruited to the study (relates to feasibility criteria regarding number of centres that are likely to be needed in a future, larger randomised controlled trial). Up to 18 months is allowed for recruitment, based on 2 years for trial to be run and 24 weeks for final patient to complete study.

  2. Number of potential participants excluded (Feasibility outcome) [ Time Frame: Up to 18 months (recruitment period duration) ]
    A record of the number of participants screened for inclusion will be kept, including whether they entered the trial or not, and if they were excluded, for what reason(s) they were excluded. This relates to number of centres likely to be required for a future trial. Up to 18 months is allowed for recruitment, based on 2 years for trial to be run and 24 weeks for final patient to complete study.

  3. Number of participants dropping out/Participant retention rate (Feasibility outcome) [ Time Frame: 24 weeks (trial duration) ]
    Number of participants withdrawing/dropping out of the study, including reasons where able; enables estimation of drop-out rates so that future studies can be appropriately sized, and also whether there are safety issues (side-effects necessitating withdrawals or patients not tolerating medications) that would suggest a future study is unnecessary.

  4. Side-effect rate (Feasibility and Safety outcome) [ Time Frame: 24 weeks (trial duration) ]

    Number of participants reporting side effects; what they are, severity and need for discontinuation of study drug all required.

    A likert scale measuring specific symptoms (palpitations, insomnia, headaches and chest pains) is also administered and these results will be recorded and presented to see if there are differences between the two groups.

    Participants also have an ECG at all study visits; any change in ECG will be recorded and the number of participants required to discontinue medications will be recorded.


  5. Number of missed or unfilled assessments (Feasibility outcome) [ Time Frame: 24 weeks (trial duration) ]
    Identifies whether appropriate data is being collected within the trial.

  6. Number of accelerometers returned with valid data (Feasibility outcome) [ Time Frame: 24 weeks (trial duration) ]
    Accelerometers are a novel outcome in this study. Their use in a trial of this nature has not been performed before. We wish to see how many participants return the accelerometer devices at the three time points in the trial, and how many of these have valid data on them; this is defined as 4 or more days of use with 10 or more hours or data. It is designed to see if it is feasible to use these devices as an outcome measure in future trials.


Secondary Outcome Measures :
  1. Fatigue Assessment Scale (FAS) (Clinical outcome) [ Time Frame: 0,2,4,6,12,18,14 and 30 weeks ]

    Change in FAS after 24 weeks, including sustainability of effect between 12 and 24 weeks (does clinical effect wane? would a future trial need to be as long?). The trial is not powered for looking for clinical difference (30 patients chosen to answer the primary feasibility questions), hence this is the secondary outcome. However, the estimate of effect size will enable power calculations for future studies to be more accurate.

    The FAS is measured at weeks 0,2,4,6,12,18,24 and 30 (6 weeks post-trial completion)


  2. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: 0,2,4,6,12,18,14 and 30 weeks ]

    Change in FACIT-F after 24 weeks, including sustainability of effect - this question is co-administered with the FAS questionnaire, as performed in a small previous study (Lower EE et al, 2008).

    The FACIT-F is measured at weeks 0,2,4,6,12,18,24 and 30 (6 weeks post-trial completion)


  3. Kings Sarcoidosis Questionnaire (KSQ) [ Time Frame: 0,6,12,18,14 and 30 weeks ]

    The KSQ is a disease-specific, health-related quality of life score used in sarcoidosis and validated in sarcoidosis cohorts within the United Kingdom. It consists of 31 questions which require rating of health problems on a scale.

    The KSQ is assessed at weeks 0,6,12,18, 24 and 30 (6 weeks post-trial completion)


  4. EuroQoL-5D (EQ5D) Questionnaire [ Time Frame: 0,6,12,18,14 and 30 weeks ]

    This generic quality of life/health status questionnaire is used both to assess health status and also for exploratory health economic analysis.

    The EQ5D is performed at weeks 0,6,12,18,24 and 30 (6 weeks post-trial completion)


  5. Short-form 36 (SF-36) Questionnaire [ Time Frame: 0,6,12,18,14 and 30 weeks ]

    The SF-36 is a generic quality of life/health status questionnaire, which can also be used for health economic modelling. Both EQ5D and SF-36 are used here as the SF-36 has a vitality domain which can reflect changes in fatigue; the two questionnaires are therefore being compared to see which would be better to use in a future trial for both assessment of health status and health economic modelling.

    The SF-36 is performed at weeks 0,6,12,18,24 and 30 (6 weeks post-trial completion)


  6. Hospital Anxiety and Depressions Score (HADS) [ Time Frame: 0,6,12,18,14 and 30 weeks ]

    Depression has been suggested as a possible cause for fatigue in sarcoidosis, but it has also been suggested that the depression stems from the fatigue. Therefore a questionnaire identifying depressive and anxiety symptoms is administered.

    The HADS is performed at weeks 0,6,12,18,24 and 30 (6 weeks post-trial completion).


  7. Accelerometer Use (wrist-worn accelerometer) [ Time Frame: 0, 12, 24 weeks ]
    A wrist-worn accelerometer can measure daily activity levels over a 7 day period. This will be performed before commencing medication (between screening and baseline visit), at the mid-point (12 weeks) and in the 2 weeks prior to medication completion (22-24 weeks). This will enable assessment in change of activity levels between the groups.

  8. Modified Shuttle Walk Test (MSWT) [ Time Frame: 0, 12, 24 weeks ]
    This incremental physical exercise test will enable an assessment in change in physical capacity/ability to be made. Like the accelerometer outcome, it is assessed at 0,12 and 24 weeks.


Other Outcome Measures:
  1. Health Economic/Utility Use [ Time Frame: 0, 12, 24 weeks ]
    A custom questionnaire based on existing tools will be administered at weeks 0,12 and 24 to look for changes in use of health and social facilities/services, as well as time off work/change in working patterns.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643732


Contacts
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Contact: Chris Atkins, MBBS 01603 591594 c.atkins@uea.ac.uk
Contact: Andrew M Wilson, MD 01603 591257 a.m.wilson@uea.ac.uk

Locations
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United Kingdom
Norfolk and Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Marcus Flather, MB/BS       marcus.flather@nnuh.nhs.uk   
Contact: Lisa Chalkley       lisa.chlakley@nnuh.nhs.uk   
Sub-Investigator: Chris Atkins, MB/BS         
Sponsors and Collaborators
University of East Anglia
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Investigators
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Principal Investigator: Andrew M Wilson, MD University of East Anglia

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT02643732     History of Changes
Other Study ID Numbers: 170-11-15
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan for anonymised data to be available through data repository for analysis by other researchers with permission of team.
Keywords provided by University of East Anglia:
Activity
Additional relevant MeSH terms:
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Methylphenidate
Sarcoidosis
Fatigue
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents