Provigil clinical trials


A double-blind pilot study to evaluate the safety and efficacy of provigil® (modafinil) at fixed/flexible doses, in conjunction with identified ssris for the treatment of excessive sleepiness in patients with mild to moderate depression with attendant symptoms of sleepiness and fatigue. METHODS: The authors conducted a multicenter, randomized, double-blind, placebo-controlled, phase 3, clinical trial to examine the effect of modafinil on patient-reported fatigue in cancer patients undergoing chemotherapy Today, U.S. The adverse reaction profile was similar across these studies In addition to elucidating provigil clinical trials important clinical findings regarding the magnitude and time course of potential changes in CYP2C19 and CYP3A4 activities caused by modafinil, this is also one of the first reports of a model‐informed drug interaction trial performed in an academic institution The EU Clinical Trials Register currently displays 37191 clinical trials with a EudraCT protocol, of which 6121 are clinical trials conducted with subjects less than 18 years old. This was a phase 2, single-center, randomized trial using a double-blind, placebo-controlled, crossover design. Provigil (modafinil) is a psychostimulant that was not designed for cancer patients and it is used mainly to treat people with narcolepsy. In a clinical trial for narcolepsy, 74 of the 934 patients (8%) who received PROVIGIL dropped out compared to 3% of patients that received placebo Clinical trials are research studies conducted in an effort to improve overall patient health and care. Department of Labor, about 14 million. Methods. This evidence stems from clinical trials dating back to the early 2000s. The Registry is designed for open enrollment of all patients who meet the inclusion criteria. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial. K. In addition, your doctor might recommend that you develop a regular nighttime sleep schedule and avoid alcohol and medications that can affect your sleep. Sleep apnea. Dr. Stroke. Cognitive enhancement: Provigil. Home +1-877-289-FEEL; Arts; Can i take unisom with guaifenesin; Taking unisom in third trimester.These medications have changed the face of treatment for Obstructive Sleep Apnea and Narcolepsy. Clinical trial efficacy: An array of evidence suggests that Provigil is effective for the treatment of depression. K. In a clinical trial for narcolepsy, 74 of the 934 patients (8%) who received PROVIGIL dropped out compared to 3% of patients that received placebo Modafinil in children with attention-deficit hyperactivity disorder. A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia [Completed] This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a. While it does not cure narcolepsy, it helps people stay awake during the day. In addition to elucidating important clinical findings regarding the magnitude and time course of potential changes in CYP2C19 and CYP3A4 activities caused by modafinil, this is also one of the first reports of a model‐informed drug interaction trial performed in an academic institution The number of patients receiving modafinil increased almost 10-fold during the study period, from 57 768 in 2002 to 555 691 in 2009. In nearly every trial, researchers noted substantial benefit from Provigil among individuals with various types of depression.

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In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses) Provigil was not designed for cancer patients, it is used mainly to treat people with narcolepsy. Efficacy and safety of modafinil (Provigil has not been validated previously in a clinical trial.The VAS-F, which was used in the Canadian MS Research Group trial,13 differs from the FSS and MFIS scales in that it provides a glo-bal impression of fatigue and does not focus on the impact of. Our clinical trials for sleep disorders have included medication such as Xyrem, Provigil and Nuvigil. Cephalon has announced that its Phase III studies of 150- and 250-mg daily doses of Nuvigil in patients suffering from either excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) or obstructive sleep apnea/hypopnea syndrome (OSA/HS) show that the medication significantly improves wakefulness and the overall clinical condition of patients as compared to placebo Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices. View All Result. The most frequent reasons for discontinuation that occurred at a higher rate for Provigil than placebo patients were headache (2%), nausea, anxiety, dizziness. Systemic steroid therapy within 30 days; Known hypersensitivity or intolerance, to Provigil or related substances or to any component of the formulation. Modafinil is a wake-promoting agent that is pharmacologically different from other stimulants. Thomas Kaelin Dr. Idiopathic hypersomnia, a condition similar to narcolepsy, is characterized by constant or recurrent daytime sleepiness with no other cause of sleepiness, prolonged nocturnal sleep, difficulty. Clinical Edit Criteria Proposal Provigil 100 mg tablets 186 $160,655 Provigil 200 mg tablets 834 $897,726 o Multiple sclerosis requires trial of amantadine in past year • Lack of history of stimulant use in past 90 days • Compliance 90/120 days Clinical trial efficacy: An array of evidence suggests that Provigil is effective for the treatment of depression. Methods: Patients aged 18–65 years with a diagnosis of MS, a stable disability level ≤6 on the Kurtzke extended disability status scale (EDSS), and a mean score >4 on the fatigue severity scale (FSS) were eligible for the 9 week, single blind, phase 2, two centre study. Results— A total of 232 stroke survivors were screened and 36 were randomized Adults who have a growth hormone deficiency — not the expected decline in growth hormone due to aging — might be prescribed synthetic HGH by their doctors. This evidence stems from provigil clinical trials clinical trials dating back to the early 2000s. Secretary of Commerce Wilbur Ross announced the affirmative preliminary determinations in the countervailing duty (CVD) investigations, finding that exporters of biodiesel from Argentina and Indonesia received countervailable subsidies of 50.29 to 64.17 percent and 41.06 to 68.28 percent, respectively.. Related Clinical Trial ‘A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy’ The Nuvigil and Provigil Pregnancy Registry Sleep Disorders of Patients With Diseases of the Nervous System Neurophysiologic Correlates of Hypersomnia Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients. Consolidated Clinical Trials has been a leading clinical research company in the tri-state area over the past 18 years We have coordinated and completed over 100 trials in a variety of therapeutic areas at more than a dozen local investigative sites, assisting scores of patients in treating their medical conditions.. Clinical trial efficacy: An array of evidence suggests that Provigil is effective for the treatment of depression. Our participation in clinical trials for sleep disorders has resulted in medications such as Xyrem, Provigil, Nuvigil and Sunosi being marketed Drug companies need to do a series of lab tests and assays, followed by several rounds of animal testing, and then on to phase I, II, and III clinical trials involving humans. Uses Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder; Side Effects Common side effects include dizziness, headache, trouble sleeping and nausea. South Carolina Sleep Medicine, LLC and Lowcountry Lung and Critical Care, PA collaborate with our team of dedicated research professionals working with sponsors to help bring new mediations to market. Rugino TA, Samsock TC. In nearly every trial, researchers noted substantial benefit from Provigil among individuals with various types of depression. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006) Consolidated Clinical Trials has been a leading clinical research company in the tri-state area over the past 18 years We have coordinated and completed over 100 trials in a variety of therapeutic areas at more than a dozen local investigative sites, assisting scores of patients in treating their medical conditions.. John Rucker. Elizabeth McNeil, MD NDA 20-717, s021 PROVIGIL (modafinil) 7.1.3 Dropouts and Other Significant Adverse Events 28 7.1.4 Other Search Strategies 38 7.1.5 Common Adverse Events 38 7.1.6 Less Common Adverse Events 43 7.1.7 Laboratory Findings 44 7.1.8 Vital Signs 48 7.1.9 Electrocardiograms (ECGs) 51 7.1.10 Immunogenicity 52 7.1.11 Human Carcinogenicity 52. Objective: To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis (MS). Pemoline in a placebo-controlled trial (3) failed to show significant effect on fatigue in MS. In foreign, controlled clinical trials, reasons for discontinuation were similar to those in US trials. Self-Study Module CNE/CME Available Track your progress and receive CE credit. Provigil and Nuvigil are not approved for pediatric use. Restrictions. Dr. In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of Provigil) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days Objective: To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis (MS). Objective: This is one of two separate clinical trials to evaluate the efficacy and safety of modafinil, a novel wake-promoting agent, in patients with excessive daytime sleepiness (EDS. The function and activities of the Nuvigil/Provigil Pregnancy Registry will be publicized through direct mailings to obstetricians and pharmacists In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction Clinical Trials Related to Provigil (Modafinil) Modafinil - Escitalopram Study for Cocaine Dependence [Completed].