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Is Provigil Fda Approved For Ms

Provigil Online Pharmacy Reviews -> Provigil Vaikutusaika

Posted by Saramar on 2022-11-28

This randomized clinical trial tests the efficacy of Modafinil for the treatment of new learning and memory deficits in MS. Twenty subjects with clinically definite MS and objectively documented new learning impairment will be included in the study. All subjects will Fds baseline neuropsychological testing and EDSS to document current levels of functioning in new learning and Provigol abilities. Subjects will then be randomly assigned to either group 1 or group 2. They will then undergo follow-up neuropsychological assessment and follow-up EDSS to evaluate any medication effects.

After the follow-up evaluation, there will be a washout period of one week in which no medication will be administered. Group 1 will then receive a placebo medication for 2 Pgovigil. A second follow-up evaluation will be conducted following this latter Approbed of the study.

The subjects and the experimenter administering the neuropsychological evaluation will be blind to group membership. Deficits in long-term episodic memory in MS are a major complaint of patients, and have been noted to be a significant contributor to disability by numerous researchers.

Specifically, research at KMRREC Is Provigil Fda Approved For Ms clearly shown that verbal memory impairment in MS is primarily a function of poor acquisition of information, rather than retrieval failure.

However, once this learning has occurred, both MS and healthy control groups have comparable recall at minutes, minutes, and 1-week time periods Appendix B. The treatment of memory deficits has been the focus of research in numerous neurological populations, yet it has received little attention in MS.

Greene and colleagues conducted a week trial of Donepezil for the treatment of cognitive symptoms in MS, noting the medication to be useful for this population. Yet few other medication trials have been accomplished. In addition, facilitation of glutamatergic transmission has been shown to promote long-term potentiation, which is hypothesized to be involved in the encoding of new memories e. One might therefore expect improvements in new learning and memory formation with the manipulation of glutamate and aspartate receptors.

Therefore, the inhibition of GABA should additionally enhance new learning and memory functioning. Modafinil accomplishes both of these neurochemical effects. Animal studies have indicated that Modafinil significantly increases both aspartate and glutamate at the regional level, while decreasing the level of GABA through the inhibition of its release.

Provigil (Modafinil) - Oral

Modafinil has been shown to be quite safe. Headaches are the most common side effect,29,9 with other more common side effects including nausea, vomiting, nervousness, and anxiety. Modafinil therefore demonstrates efficacy within other patient groups with neurological impairment.

Due to the fact that Modafinil has been shown to act on glutamate and aspartate receptors, specifically influencing the hippocampus, it is hypothesized that treatment with this medication will result in better performance in tests of new learning and memory in an MS sample. Participants: Twenty subjects with clinically definite MS and objectively documented new learning impairment will be included in the study. Subjects will be excluded from participation in the presence of significant language comprehension deficits.

Additional exclusion criteria are as follows: age greater than 60, less than 1-month post most recent exacerbation, current treatment with corticosteroids, significant neurological history aside from MS e. Procedure: Please see study overview in Appendix C. All potential subjects will undergo initial neuropsychological NP testing Appendix E to screen for study inclusion criteria, namely the presence of new learning impairment.

Subjects will only be Is Provigil Fda Approved For Ms in the current protocol if they are classified as impaired in new learning and memory ability, with intact language abilities. Such impairment will be defined as performance at least 1. This test has been shown to be sensitive to deficits in new learning abilities commonly observed in MS.

In addition, performance on the Token Test see Appendix D must be within normal limits. All subjects qualifying for the study will then undergo baseline neuropsychological testing to document current levels of functioning in new learning and memory abilities. A two-period crossover design will be used in which subjects will be randomly assigned to one of the two groups. Subjects in both groups will be seen by a physician Dr.

Greenwald who will assess their current neurological status and complete the EDSS. Importantly, the subjects and the experimenter administering the neuropsychological evaluation will be blind to group membership.

All Is Provigil Fda Approved For Ms will be asked to keep a precise journal during both arms of the study, recording the time at which the medication was taken, any side effects, activities during the day, and any changes in cognition for each activity. They will be encouraged to contact the prescribing physician if they encounter any difficulties.

Provigil (Modafinil) for Multiple Sclerosis | MyMSTeam

See Foe 1 for study protocol. A power analysis is presented in Appendix F. We hypothesize that there will be a significant interaction of time of testing by group.

Cognitive performance is expected to improve from the 1st to the 2nd testing sessions in the group 1, with just a mild practice effect documented in the group 2. Additionally, we expect a return to baseline cognitive functioning from the 2nd to the 3rd NP assessment in Group 1, with an improvement in performance noted in group 2 due to medication effects.

No main effects are anticipated.

Provigil (Modafinil) Oral: Uses, Side Effects, Dosages

A Approbed regression will be used to examine the influence of memory performance and perception of memory abilities on changes in depression and anxiety at the various assessment intervals. We hypothesize that as memory improves, depression and anxiety levels will decrease. Additionally, as the perception of memory improves, depression and anxiety will also decrease.

Fatigue impact will be assessed using a wearable monitor, the PRO-Diary CamNtech - a wrist-worn accelerometer-based activity Ffa which also contains a self-report user interface.

Using a numerical rating scale, participants will rate their fatigue impact, and enter the score into the user-interface on the PRO-Diary four times each day, for 7 days, at baseline pre-intervention and at 12 weeks post-intervention.

The FDA approved Provigil to treat excessive daytime sleepiness in patients with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. buymodafinilntx.com › Health A-Z › Sleep Disorders.

All scores over the Is Provigil Fda Approved For Ms days will be averaged to produce an aggregate fatigue impact score. Higher scores indicate greater Ix impact.

Change in fatigue impact between baseline and 12 weeks will be compared between the 3 treatment groups. Fatigability will be assessed using a wearable monitor, the PRO-Diary CamNtech - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface. The fatigability score will be calculated as the ratio of the self-reported fatigue intensity rating using a numerical rating score divided by the participant's concurrent physical activity level measured as the average number of activity counts per Fo.

All fatigability scores will be averaged over the 7 days to create an aggregate fatigability Provigli. Higher scores indicate greater fatigability. Change in fatigability between baseline and 12 weeks will be compared between the 3 treatment groups.

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. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Porvigil if Fva registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details.

Last Update Posted : March 3, Study Description. This clinical trial will compare the Appproved of 3 treatments for fatigue in Multiple Sclerosis: 1 a commonly used behavioral treatment strategy telephone-based cognitive Provigill therapy2 a commonly used medication modafiniland 3 a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks.

Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater Is Provigil Fda Approved For Ms in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.

MedlinePlus related topics: Fatigue Multiple Sclerosis. Drug Information available for: Modafinil. FDA Resources. Arms and Interventions. Cognitive behavioral therapy CBT is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors Appfoved.

Modafinil in Multiple Sclerosis

Modafinil is a safe, well-tolerated and effective wake-promoting agent oral medication that is FDA-approved for the treatment of fatigue related to sleep disorders.

Outcome Measures. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using rPovigil contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications: Krupp L. Fatigue is intrinsic to multiple sclerosis MS and is the most commonly reported symptom of the disease.

Mult Scler. A prospective study of patterns of fatigue in multiple sclerosis. Eur J Neurol. Epub Sep

Modafinil is a wakefulness-promoting agent approved to improve wakefulness in adults who experience excessive sleepiness due to obstructive sleep apnea or. Provigil is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive sleepiness associated with.

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