Fatigue in Sarcoidosis - Treatment With Methylphenidate
NCT ID: NCT02643732
Last Updated: 2017-01-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-11-30
Study Completion Date
2018-07-31
Brief Summary
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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.
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Detailed Description
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Sarcoidosis and fatigue
Sarcoidosis is a systemic granulomatous disease that affects all ethnic groups and ages. In the United Kingdom the incidence of the disease is 5.0 cases per 100,000 patient years, with a mean age at diagnosis of 47 years, frequently affecting patients of working age(Gribbin et al). The cause is unknown and there is no cure(Iannuzzi et al). Many patients suffer from debilitating fatigue for which there is presently no treatment.
Fatigue has been described as a "core symptom" of sarcoidosis, and is present in up to 80% of patients(Marcellis et al). A "post-sarcoidosis chronic-fatigue syndrome" has been described(James), denoting the presence of fatigue where there is no evidence of active disease. The presence of this symptom has been shown to adversely affect quality of life(Michielsen et al). Although there increased risk of obstructive sleep apnoea and sleep-disordered breathing occurring in sarcoidosis patients(Michielsen et al; Drent et al) the majority of patients have no identifiable cause for fatigue other than their sarcoidosis.
Both the British Thoracic Society(Bradley et al) and American Thoracic Society(Costabel et al) produce guidelines for physicians treating people with sarcoidosis. Neither guideline gives any advice on treatment of fatigue. Fatigue is a common problem in sarcoidosis. In a study of 76 patients with sarcoidosis, 50.7% reported pathological levels of fatigue, defined as a Fatigue Assessment Scale (FAS) score of greater than 21 units, compared with 8.6% of controls. People reporting fatigue scores above 21, had poorer EuroQoL Visual Analogue Scale (EQVAS) scores compared with people reporting fatigue scores of 21 or below (mean scores 0.561 vs 0.792 , p\<0.001) (Unpublished data, Norfolk and Norwich University Hospital). This shows that fatigue impacts upon quality of life in sarcoidosis.
Methylphenidate - a treatment for fatigue
Methylphenidate (and its isomer dexmethylphenidate), which is used to treat attention deficit hyperactivity disorder(Keating et al), is an amphetamine-derivative which works by amplifying dopamine signals through inhibition of dopamine reuptake and enhancement of extracellular dopamine in the basal ganglia(Volkow et al). It has been used to treat fatigue in other settings with good effect. In a placebo-controlled, double-blind trial in post-chemotherapy participants with fatigue, methylphenidate exhibited a clinically significant reduction in fatigue(Lower et al). Prior to the results from this trial, a Cochrane review of treatments for cancer-related fatigue from 5 RCTs had shown an improvement in fatigue through methylphenidate treatment, leading them to conclude "the current evidence supports the use of psychostimulants in cancer-related fatigue"(Minton et al). Another trial investigated methylphenidate for the treatment of fatigue in 109 HIV-positive patients over a 6-week period. Methylphenidate improved fatigue on a visual analogue scale, with a 26.2 point increase (maximum of 100) from baseline, with 41% of participants receiving the drug demonstrating a greater than 50% improvement in visual analogue scale score(Breitbart et al). In contrast, no difference between methylphenidate and placebo was seen in a cohort of 68 fatigued patients who had received radiotherapy for brain tumours followed over a 12 week period(Butler et al).
In the case of sarcoidosis, so far only one small study has investigated the use of dexmethylphenidate for fatigue(Lower et al). Ten patients were included in this double blind crossover trial. Participants reported clinically and statistically significant improvements in fatigue measured by both the FAS and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score after 8 weeks of treatment, although no statistically significant improvement was seen in six minute walk distance (6MWD) compared with placebo. The drug was well tolerated; all participants completed the study and no significant increase in side effects was noted between the patients receiving placebo and dexmethylphenidate.
Rationale for current study
Prior to designing a definitive study, issues about the feasibility of undertaking a sufficiently large trial require to be resolved. Completed trials have only used methylphenidate for 8-12 weeks, so sustainability of effect, tolerability of medications over a long period and retention of participants within the trial are unknown. Whilst the use of medications such as methylphenidate may not be used on a continuous basis in the clinical setting, their use on a 6-12 month basis may not be unreasonable, hence the need to review the effect of the medication over a longer period. Furthermore, it is unclear how many people would be willing to participate in a longer trial , and how many potential participants would be suitable for enrolment using our present inclusion and exclusion criteria. For this reason, a feasibility trial is necessary before committing to a larger trial.
In addition, this trial will evaluate exercise and activity through both a modified shuttle walk test (MSWT) and accelerometer-measured change in activity levels. Although methylphenidate has not been shown to significantly improve 6MWD(Lower et al), a larger study using a more responsive test may be required to evaluate exercise capacity in this setting. This could be because as a self-paced test it is a sub-maximal exercise test - this has been shown to be the case in a study of interstitial lung disease (ILD) patients (including sarcoidosis) where peak oxygen uptake, carbon dioxide uptake and ventilation were all lower during 6MWD than on cardiopulmonary exercise testing(Holland et al). By not reaching their maximum exercise level this may make the test less responsive to change. This is particularly relevant given that the ILD cohort who did not reach maximal exercise or oxygen uptake during their 6MWD were likely to be much more limited in cardiopulmonary function than the cohort anticipated to be enrolled in a study of treatment of fatigue and therefore much more likely to get closer to their peak oxygen uptake during a 6MWD. Given that activity levels measured by accelerometers in people with sarcoidosis is related to fatigue (Korenromp et al), this trial will evaluate the feasibility of using them as an outcome measure in a clinical trial, including whether participants will wear the devices for long enough (i.e. 4 days out of 7, at least 10 hours per day) to get valid data for estimating daily activity levels.
Study Design
This is a parallel-arm RCT including 30 participants, randomised on a 1.5:1 basis in favour of the active treatment arm (18 participants will receive methylphenidate, 12 will receive placebo). The rationale of this trial is to determine the feasibility of designing and performing a sufficiently large RCT in the future looking for proof of clinical effect of methylphenidate in the treatment of sarcoidosis-associated fatigue. As a result, this study is not powered to detect a clinical difference in a clinical outcome, although these will be measured and analysed (the estimate of effect size will be used for future power calculations). Therefore the primary outcomes regard feasibility and safety, not treatment effect (see Outcome Measures section).
Participants will receive either methylphenidate or placebo for 24 weeks, with a further assessment performed 6 weeks after completion of the trial. They will be carefully monitored over the initial 6 weeks to ensure that they are stable on the drug - during this time they will be seen every 2 weeks (at 0,2,4 and 6 weeks). Following this period they will be seen less frequently (at 12 and 24 weeks, with postal questionnaires performed at 18 weeks) to detect sustainability of effect. Determining if treatment effect is sustained over the second half of the trial period will help to establish how long any future trial will need to be. Although each participant is required to attend frequent visits to the hospital, this trial has been designed in conjunction with sarcoidosis patients and ensures that participant safety is paramount.
Sarcoidosis is a systemic granulomatous disease that affects all ethnic groups and ages. In the United Kingdom the incidence of the disease is 5.0 cases per 100,000 patient years, with a mean age at diagnosis of 47 years, frequently affecting patients of working age(Gribbin et al). The cause is unknown and there is no cure(Iannuzzi et al). Many patients suffer from debilitating fatigue for which there is presently no treatment.
Fatigue has been described as a "core symptom" of sarcoidosis, and is present in up to 80% of patients(Marcellis et al). A "post-sarcoidosis chronic-fatigue syndrome" has been described(James), denoting the presence of fatigue where there is no evidence of active disease. The presence of this symptom has been shown to adversely affect quality of life(Michielsen et al). Although there increased risk of obstructive sleep apnoea and sleep-disordered breathing occurring in sarcoidosis patients(Michielsen et al; Drent et al) the majority of patients have no identifiable cause for fatigue other than their sarcoidosis.
Both the British Thoracic Society(Bradley et al) and American Thoracic Society(Costabel et al) produce guidelines for physicians treating people with sarcoidosis. Neither guideline gives any advice on treatment of fatigue. Fatigue is a common problem in sarcoidosis. In a study of 76 patients with sarcoidosis, 50.7% reported pathological levels of fatigue, defined as a Fatigue Assessment Scale (FAS) score of greater than 21 units, compared with 8.6% of controls. People reporting fatigue scores above 21, had poorer EuroQoL Visual Analogue Scale (EQVAS) scores compared with people reporting fatigue scores of 21 or below (mean scores 0.561 vs 0.792 , p\<0.001) (Unpublished data, Norfolk and Norwich University Hospital). This shows that fatigue impacts upon quality of life in sarcoidosis.
Methylphenidate - a treatment for fatigue
Methylphenidate (and its isomer dexmethylphenidate), which is used to treat attention deficit hyperactivity disorder(Keating et al), is an amphetamine-derivative which works by amplifying dopamine signals through inhibition of dopamine reuptake and enhancement of extracellular dopamine in the basal ganglia(Volkow et al). It has been used to treat fatigue in other settings with good effect. In a placebo-controlled, double-blind trial in post-chemotherapy participants with fatigue, methylphenidate exhibited a clinically significant reduction in fatigue(Lower et al). Prior to the results from this trial, a Cochrane review of treatments for cancer-related fatigue from 5 RCTs had shown an improvement in fatigue through methylphenidate treatment, leading them to conclude "the current evidence supports the use of psychostimulants in cancer-related fatigue"(Minton et al). Another trial investigated methylphenidate for the treatment of fatigue in 109 HIV-positive patients over a 6-week period. Methylphenidate improved fatigue on a visual analogue scale, with a 26.2 point increase (maximum of 100) from baseline, with 41% of participants receiving the drug demonstrating a greater than 50% improvement in visual analogue scale score(Breitbart et al). In contrast, no difference between methylphenidate and placebo was seen in a cohort of 68 fatigued patients who had received radiotherapy for brain tumours followed over a 12 week period(Butler et al).
In the case of sarcoidosis, so far only one small study has investigated the use of dexmethylphenidate for fatigue(Lower et al). Ten patients were included in this double blind crossover trial. Participants reported clinically and statistically significant improvements in fatigue measured by both the FAS and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score after 8 weeks of treatment, although no statistically significant improvement was seen in six minute walk distance (6MWD) compared with placebo. The drug was well tolerated; all participants completed the study and no significant increase in side effects was noted between the patients receiving placebo and dexmethylphenidate.
Rationale for current study
Prior to designing a definitive study, issues about the feasibility of undertaking a sufficiently large trial require to be resolved. Completed trials have only used methylphenidate for 8-12 weeks, so sustainability of effect, tolerability of medications over a long period and retention of participants within the trial are unknown. Whilst the use of medications such as methylphenidate may not be used on a continuous basis in the clinical setting, their use on a 6-12 month basis may not be unreasonable, hence the need to review the effect of the medication over a longer period. Furthermore, it is unclear how many people would be willing to participate in a longer trial , and how many potential participants would be suitable for enrolment using our present inclusion and exclusion criteria. For this reason, a feasibility trial is necessary before committing to a larger trial.
In addition, this trial will evaluate exercise and activity through both a modified shuttle walk test (MSWT) and accelerometer-measured change in activity levels. Although methylphenidate has not been shown to significantly improve 6MWD(Lower et al), a larger study using a more responsive test may be required to evaluate exercise capacity in this setting. This could be because as a self-paced test it is a sub-maximal exercise test - this has been shown to be the case in a study of interstitial lung disease (ILD) patients (including sarcoidosis) where peak oxygen uptake, carbon dioxide uptake and ventilation were all lower during 6MWD than on cardiopulmonary exercise testing(Holland et al). By not reaching their maximum exercise level this may make the test less responsive to change. This is particularly relevant given that the ILD cohort who did not reach maximal exercise or oxygen uptake during their 6MWD were likely to be much more limited in cardiopulmonary function than the cohort anticipated to be enrolled in a study of treatment of fatigue and therefore much more likely to get closer to their peak oxygen uptake during a 6MWD. Given that activity levels measured by accelerometers in people with sarcoidosis is related to fatigue (Korenromp et al), this trial will evaluate the feasibility of using them as an outcome measure in a clinical trial, including whether participants will wear the devices for long enough (i.e. 4 days out of 7, at least 10 hours per day) to get valid data for estimating daily activity levels.
Study Design
This is a parallel-arm RCT including 30 participants, randomised on a 1.5:1 basis in favour of the active treatment arm (18 participants will receive methylphenidate, 12 will receive placebo). The rationale of this trial is to determine the feasibility of designing and performing a sufficiently large RCT in the future looking for proof of clinical effect of methylphenidate in the treatment of sarcoidosis-associated fatigue. As a result, this study is not powered to detect a clinical difference in a clinical outcome, although these will be measured and analysed (the estimate of effect size will be used for future power calculations). Therefore the primary outcomes regard feasibility and safety, not treatment effect (see Outcome Measures section).
Participants will receive either methylphenidate or placebo for 24 weeks, with a further assessment performed 6 weeks after completion of the trial. They will be carefully monitored over the initial 6 weeks to ensure that they are stable on the drug - during this time they will be seen every 2 weeks (at 0,2,4 and 6 weeks). Following this period they will be seen less frequently (at 12 and 24 weeks, with postal questionnaires performed at 18 weeks) to detect sustainability of effect. Determining if treatment effect is sustained over the second half of the trial period will help to establish how long any future trial will need to be. Although each participant is required to attend frequent visits to the hospital, this trial has been designed in conjunction with sarcoidosis patients and ensures that participant safety is paramount.
Conditions
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Sarcoidosis
Fatigue
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Methylphenidate
Methylphenidate 10mg (one tablet) twice daily, increasing to 20mg (two tablets) twice daily following assessment 2 weeks into trial.
24 weeks duration
Group Type
EXPERIMENTAL
Methylphenidate (overencapsulated)
Intervention Type
DRUG
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.
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.
Group Type
PLACEBO_COMPARATOR
Placebo (Over-encapsulated tablet)
Intervention Type
DRUG
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
DRUG
Other Intervention Names
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Tranquilyn
Eligibility 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
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
OTHER
Sponsor Role
collaborator
University of East Anglia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Andrew M Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Site Status
RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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References
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Gribbin J, Hubbard RB, Le Jeune I, Smith CJ, West J, Tata LJ. Incidence and mortality of idiopathic pulmonary fibrosis and sarcoidosis in the UK. Thorax. 2006 Nov;61(11):980-5. doi: 10.1136/thx.2006.062836. Epub 2006 Jul 14.
Reference Type
BACKGROUND
Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available.
Reference Type
BACKGROUND
Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.
Reference Type
BACKGROUND
James DG. Complications of sarcoidosis. Chronic fatigue syndrome. Sarcoidosis. 1993 Mar;10(1):1-3.
Reference Type
BACKGROUND
Michielsen HJ, Drent M, Peros-Golubicic T, De Vries J. Fatigue is associated with quality of life in sarcoidosis patients. Chest. 2006 Oct;130(4):989-94. doi: 10.1378/chest.130.4.989.
Reference Type
BACKGROUND
Turner GA, Lower EE, Corser BC, Gunther KL, Baughman RP. Sleep apnea in sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 1997 Mar;14(1):61-4.
Reference Type
BACKGROUND
Drent M, Verbraecken J, van der Grinten C, Wouters E. Fatigue associated with obstructive sleep apnea in a patient with sarcoidosis. Respiration. 2000;67(3):337-40. doi: 10.1159/000029523.
Reference Type
BACKGROUND
Bradley B, Branley HM, Egan JJ, Greaves MS, Hansell DM, Harrison NK, Hirani N, Hubbard R, Lake F, Millar AB, Wallace WA, Wells AU, Whyte MK, Wilsher ML; British Thoracic Society Interstitial Lung Disease Guideline Group, British Thoracic Society Standards of Care Committee; Thoracic Society of Australia; New Zealand Thoracic Society; Irish Thoracic Society. Interstitial lung disease guideline: the British Thoracic Society in collaboration with the Thoracic Society of Australia and New Zealand and the Irish Thoracic Society. Thorax. 2008 Sep;63 Suppl 5:v1-58. doi: 10.1136/thx.2008.101691. No abstract available.
Reference Type
BACKGROUND
Costabel U, Hunninghake GW. ATS/ERS/WASOG statement on sarcoidosis. Sarcoidosis Statement Committee. American Thoracic Society. European Respiratory Society. World Association for Sarcoidosis and Other Granulomatous Disorders. Eur Respir J. 1999 Oct;14(4):735-7. doi: 10.1034/j.1399-3003.1999.14d02.x. No abstract available.
Reference Type
BACKGROUND
Keating GM, Figgitt DP. Dexmethylphenidate. Drugs. 2002;62(13):1899-904; discussion 1905-8. doi: 10.2165/00003495-200262130-00009.
Reference Type
BACKGROUND
Volkow ND, Fowler JS, Wang G, Ding Y, Gatley SJ. Mechanism of action of methylphenidate: insights from PET imaging studies. J Atten Disord. 2002;6 Suppl 1:S31-43. doi: 10.1177/070674370200601s05.
Reference Type
BACKGROUND
Lower EE, Fleishman S, Cooper A, Zeldis J, Faleck H, Yu Z, Manning D. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. J Pain Symptom Manage. 2009 Nov;38(5):650-62. doi: 10.1016/j.jpainsymman.2009.03.011.
Reference Type
BACKGROUND
Minton O, Richardson A, Sharpe M, Hotopf M, Stone P. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD006704. doi: 10.1002/14651858.CD006704.pub3.
Reference Type
BACKGROUND
Breitbart W, Rosenfeld B, Kaim M, Funesti-Esch J. A randomized, double-blind, placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease. Arch Intern Med. 2001 Feb 12;161(3):411-20. doi: 10.1001/archinte.161.3.411.
Reference Type
BACKGROUND
Butler JM Jr, Case LD, Atkins J, Frizzell B, Sanders G, Griffin P, Lesser G, McMullen K, McQuellon R, Naughton M, Rapp S, Stieber V, Shaw EG. A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1496-501. doi: 10.1016/j.ijrobp.2007.05.076. Epub 2007 Sep 14.
Reference Type
BACKGROUND
Lower EE, Harman S, Baughman RP. Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.
Reference Type
BACKGROUND
Holland AE, Dowman L, Fiore J Jr, Brazzale D, Hill CJ, McDonald CF. Cardiorespiratory responses to 6-minute walk test in interstitial lung disease: not always a submaximal test. BMC Pulm Med. 2014 Aug 11;14:136. doi: 10.1186/1471-2466-14-136.
Reference Type
BACKGROUND
Korenromp IHE, Heijnen CJ, Vogels OJM, van den Bosch JMM, Grutters JC. Characterization of chronic fatigue in patients with sarcoidosis in clinical remission. Chest. 2011 Aug;140(2):441-447. doi: 10.1378/chest.10-2629. Epub 2011 Feb 17.
Reference Type
BACKGROUND
Atkins C, Jones A, Clark AB, Stockl A, Fordham R, Wilson AM. Feasibility of investigating methylphenidate for the treatment of sarcoidosis-associated fatigue (the FaST-MP study): a double-blind, parallel-arm randomised feasibility trial. BMJ Open Respir Res. 2021 May;8(1):e000814. doi: 10.1136/bmjresp-2020-000814.
Reference Type
DERIVED
Atkins C, Fordham R, Clark AB, Stockl A, Jones AP, Wilson AM. Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol. BMJ Open. 2017 Dec 4;7(12):e018532. doi: 10.1136/bmjopen-2017-018532.
Reference Type
DERIVED
Other Identifiers
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170-11-15
Identifier Type: -
Identifier Source: org_study_id
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A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
NCT00955279
COMPLETED
PHASE2
Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
NCT02725177
COMPLETED
NA
Treatment of Pulmonary Sarcoidosis With Pentoxifylline
NCT00001877
COMPLETED
PHASE2
Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis
NCT04017936
COMPLETED
PHASE2
Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome
NCT04213274
WITHDRAWN
PHASE2
Pathogen Specific Immunity in Patients With Sarcoidosis
NCT00217789
COMPLETED
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
NCT05351554
TERMINATED
PHASE2
Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare
NCT03910543
COMPLETED
PHASE1
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
NCT03962543
ACTIVE_NOT_RECRUITING
PHASE2
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
NCT02546388
COMPLETED
NA
Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
NCT00690911
WITHDRAWN
PHASE2
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
NCT03320707
COMPLETED
PHASE1
Repurposing Tilmanocept for Cardiac Sarcoidosis
NCT07159074
RECRUITING
PHASE2
Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis
NCT05841758
RECRUITING
PHASE4
Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
NCT03485547
COMPLETED
PHASE1
Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis
NCT03770273
COMPLETED
PHASE2
Study of Mast Cell Precursors
NCT00001756
COMPLETED
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
NCT06450639
RECRUITING
PHASE2