Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Fatigue

Sleepiness

Disorders of Excessive Somnolence

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

All Drugs and Chemicals

Modafinil

Subjects who take modafinil for cancer-related fatigue for 4 weeks.

Hye youn Park, M.D.

Inyoung Yoon, M.D., Ph.D.

Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.

The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Seoul National University Bundang Hospital

Professor

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Arrhythmia Agents

Antihypertensive Agents

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Lipid Regulating Agents

Gastrointestinal Agents

Analgesics

Antitussive Agents

Respiratory System Agents

Bone Density Conservation Agents

Vasoconstrictor Agents

Cardiotonic Agents

Anti-Obesity Agents

Other Dietary Supplements

Caffeine

Losartan

Midazolam

Rosuvastatin Calcium

Omeprazole

Levomethorphan

Dextromethorphan

Bupropion

Calcium

Calcium, Dietary

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Phosphodiesterase Inhibitors

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Cytochrome P-450 Enzyme Inhibitors

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Excitatory Amino Acid Antagonists

Analgesics, Opioid

Narcotics

Patients will receive a single oral dose of the CYP Probe Cocktail on Day -7, Day 1, and Day 14:

* 25 mg losartan oral tablet
* 30 mg dextromethorphan oral capsule
* 50 mg caffeine oral liquid
* 20 mg omeprazole oral capsule
* 2 mg midazolam oral syrup

encorafenib/binimetinib continuous daily dosing starting Day 1:

* 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD)
* 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID)

All drugs will be taken within 10 minutes.

Patients will receive a single oral dose of rosuvastatin and bupropion once on Day -7, Day 1 and Day 14:

* 10 mg rosuvastatin oral tablet
* 75 mg bupropion immediate release (IR) oral tablet

encorafenib/binimetinib continuous daily dosing starting Day 1:

* 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD)
* 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID)

All drugs will be taken within 10 minutes.

Patients will begin encorafenib/binimetinib continuous daily dosing starting Day 1:

* 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD)
* 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID)

then receive continuous treatment of modafinil on Day 15 through Day 21:

- 400 mg modafinil tablet once daily (QD)

losartan

dextromethorphan

caffeine

omeprazole

midazolam

rosuvastatin

bupropion immediate release (IR)

encorafenib

binimetinib

modafinil

Pfizer CT.gov Call Center

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Pierre Fabre Laboratories

Pfizer

Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.

Inactive sugar pill, 2 are taken once a day in the morning

sugar pill

Gary R. Morrow, Ph.D., M.S.

The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.

The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.

Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:

1. better control of the fatigue reported by patients during and following cancer treatment is needed,
2. there are few systematic data on the etiology of fatigue following cancer treatment, and
3. there is evidence indicating that chemotherapy is associated with cognitive dysfunction.

Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.

The primary objective is to:

* compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks

Secondary objectives are to:

* assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
* assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
* investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction

Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.

Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

Cephalon

University of Rochester

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Methylphenidate

10 mg by mouth (PO) twice daily for 4 Weeks

10 mg by mouth (PO) twice daily x 4 Weeks

IR Methylphenidate

SR Methylphenidate

Jeffrey S. Wefel, PhD

Primary Objective:

* To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors.

All three drugs used in this clinical research study are widely used stimulants to help cancer patients who have fatigue and problems with concentration.

Before treatment starts, you will have a physical exam, including measurement of blood pressure, and neuropsychological and symptom evaluations. The neuropsychological evaluation is made up of tests of attention, memory, speech, and other brain functions, and takes about 30 minutes to complete. The other test evaluates symptoms you may be experiencing, such as fatigue or depression, and takes about 10 minutes to complete.

You will be randomly assigned (as in the toss of a coin) to one of three treatment groups. Participants in the first group will receive Immediate Release (IR) methylphenidate. Participants in the second group will receive Sustained Release (SR) methylphenidate. Participants in the third group will receive modafinil. There is an equal chance of being assigned to any of the groups. After you are randomized, you will contact the M. D. Anderson pharmacy to receive your assigned medication. You will receive a total of 5 weeks worth of medication. The extra week of medication is to allow for buffer should there be any conflict in rescheduling the follow-up evaluation.

IR methylphenidate is a pill taken twice a day. Both SR methylphenidate and modafinil are pills taken once a day. The amount of the medicine is the same for all three groups. You will take the medication every day for a total of 4 weeks.

You will be asked to complete a study calendar, which will be provided by the research staff. In the study calendar, you will be asked to initial after you take the study drug each day, and to record any side effects you may experience. You will be required to return the completed study calendar at the final evaluation visit, along with the empty bottles and any of the study drugs that may be left over.

You will remain on treatment for 4 weeks and return for a final evaluation. A follow-up neuropsychological evaluation and evaluation of symptoms will be performed. At the end of the study treatment period, you will be allowed to remain on active treatment if you wish to. You can discuss with your doctor whether to continue on the same medication or to try another one.

This is an investigational study. All of the study drugs are FDA approved and currently are used to help brain tumor patients. A total of 75 patients will take part in this study. All will be enrolled at M. D. Anderson.

Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors

'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow "trail" made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).

For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).

M.D. Anderson Cancer Center

Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks

Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination lead to limited analysis.

Jeffrey Wefel, PHD/ Associate Professor, Neuropsychology

Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.

Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score

Patient Cognitive Test Scores at End of Treatment Period

Overall Study

Pain

Stuart A Grossman, MD

* The primary objective of this study is to evaluate the efficacy of modafinil in the treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).
* The secondary objective is to estimate the frequency and severity of toxicity associated with Modafinil (400mg) in patients with opioid induced sedation.

Sedation is a common side effect of opioid analgesics. In patients where this remains a dose limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been the primary class of agents used to counteract sedation. Modafinil is a novel stimulant that is FDA approved for the treatment of narcolepsy and has a very different side effect profile than traditional stimulants. The potential role of this agent in the treatment of opioid induced sedation remains undefined. This study, which utilizes a prospective, randomized, blinded, cross-over design, will collect daily information on sedation (Epworth Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the Johns Hopkins Medical Institutions.

Modafinil in Opioid Induced Sedation

A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days

One capsule daily for 14 days, increasing to two capsules daily for 14 days

Placebo

Bee Wee, PhD

Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's usual ability to function. It is believed to be both the most common and the most distressing symptom experienced by those with cancer. Despite the magnitude of the problem, there has been inadequate research into the management of cancer-related fatigue.

Central nervous system (CNS) stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil is a relatively new stimulant with few side-effects. There is increasing evidence that modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer conditions. No good quality studies have been published evaluating modafinil in patients with cancer, despite multiple calls for such research to be undertaken.

The investigators have completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on fatigue in patients with lung cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil long-term. However, the study was too small for definite conclusions to be drawn.

This larger, definitive study, funded by a National Cancer Research Institute research award, will establish more clearly whether modafinil can improve fatigue in patients with lung cancer. Two hundred and six patients will be recruited from a number of sites across the UK. Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every day for a month. The fatigue levels of the two groups will be compared. Confirmation that modafinil can relieve cancer-related fatigue could have a highly significant impact on the quality of life of the very large number of patients suffering from this common and distressing symptom.

Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study	NCT02385656	Fatigue	Modafinil	20 Years - 65 Years	Seoul National University Bundang Hospital
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors	NCT03864042	Advanced Solid ... Metastatic Mela...	losartan dextromethorpha... caffeine omeprazole midazolam rosuvastatin bupropion immed... encorafenib binimetinib modafinil	18 Years -	Pfizer
Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer	NCT00178373	Cancer Fatigue Chemotherapy	Modafinil sugar pill	18 Years -	University of Rochester
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning	NCT00418691	Brain Tumor	IR Methylphenid... Modafinil SR Methylphenid...	18 Years -	M.D. Anderson Cancer Center
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning	NCT00418691	Brain Tumor	IR Methylphenid... Modafinil SR Methylphenid...	18 Years -	M.D. Anderson Cancer Center
Modafinil in Opioid Induced Sedation	NCT00267332	Cancer Pain	Modafinil	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Modafinil for the Treatment of Fatigue in Lung Cancer V9.0	NCT00829322	Carcinoma, Non-...	Modafinil Placebo	18 Years -	University of Oxford
Modafinil for the Treatment of Fatigue in Lung Cancer V9.0	NCT00829322	Carcinoma, Non-...	Modafinil Placebo	18 Years -	University of Oxford
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)	NCT00917748	Prostatic Neopl... Breast Cancer	DOCETAXEL(XRP69... Modafinil Placebo of Moda...	18 Years -	Sanofi
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy	NCT01348607	Central Nervous... Fatigue Specific Disord...	methylphenidate... modafinil placebo	8 Years - 18 Years	University of South Florida
Modafinil for the Treatment of Fatigue in Lung Cancer V9.0	NCT00829322	Carcinoma, Non-...	Modafinil Placebo	18 Years -	University of Oxford

Spots Global Cancer Trial Database for modafinil

Every month we try and update this database with for modafinil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for modafinil

Every month we try and update this database with for modafinil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for modafinil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.