Prior and Concomitant Medications. Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 and 4.2. Prior and concomitant medications and therapies will be coded using the latest version of the World Health Organization Drug Dictionary.
Prior and Concomitant Medications. Information regarding prior medications taken by the subject within the 30 days before signing the informed consent form (ICF) as well as concomitant medications taken after starting study drug will be recorded in the subject’s eCRF. Any concomitant medication deemed necessary for the welfare of the subject during the study may be given at the discretion of the investigator. This includes standard-of-care treatments/therapies for dengue should subjects deteriorate on-study due to their dengue infection. If a prohibited and kidneys; and 2) do not involve concomitant use of prohibited medications discussed above that may interfere with the PK AT-752.
Prior and Concomitant Medications. Many concomitant medications are prohibited during this study because this study has been designed to evaluate the safety and efficacy of monotherapy with TNX-102 SL tablets for the treatment of PTSD. The goal of the study is to recruit patients who are not currently using other medications to treat their PTSD, or who are not clearly benefitting from any of the medications that would need to be discontinued in order to enter this study. Since many patients with PTSD may already be taking one or more excluded medications when screened, Principal Investigators should use extreme caution when determining whether a patient, in their clinical judgment, can be safely withdrawn from current medications that are being used to treat PTSD or are otherwise excluded from the protocol. Eligible patients will not be receiving treatment with antidepressants, antipsychotic agents, mood stabilizers or anticonvulsants. In addition, eligible patients will not have taken antidepressants within 2 months of the Baseline visit. This time frame is intentionally long because it is not considered appropriate for patients to discontinue antidepressants solely to enter the study. An exception is made for the use of low-dose tricyclic agents at doses ≤ 25 mg per day, or trazodone at doses ≤ 150 mg per day, either of which may be discontinued for the purpose of enrollment but requires a 1-week medication-free period prior to randomization, as described below. Patients also must be willing and able to discontinue use of benzodiazepines, non- benzodiazepines and certain other medications frequently used to treat PTSD; e.g., prazosin; trazodone; topiramate. Discontinuation of any of these agents should only be considered if/when the patient’s clinical condition and stability will not be adversely affected. Unless otherwise stated, excluded medications (e.g., trazodone, prazosin, topiramate, alpha- adrenergic agonists or antagonists [e.g., prazosin; tamsulosin; terazosin; doxazosin, silodosin, alfuzosin, clonidine, guanfacine], buspirone, benzodiazepines, and non-benzodiazepine hypnotics [zolpidem, zaleplon, eszopiclone]) will require a 1-week drug-free period prior to the Baseline visit (Visit 2). Similarly, all opioid medications, including tramadol and tapentadol, are excluded medications. Patients on chronic opioids are not appropriate candidates for participation, but there may be patients with occasional PRN opioid usage or who were recently on a short course for acute pain who may b...
Prior and Concomitant Medications. Medications will be recorded at each study visit during the study and will be coded using World Health Organization-Drug dictionary (WHO-DD) September 2016, or later. Medications will be presented according to whether they are being taken prior to and/or during the study (concomitant). Prior medications are defined as those taken prior to the first dose of study drug. Concomitant medications are defined as those with a start date on or after the first dose of study drug, or those with a start date before the first dose of study drug that are ongoing or with a stop date on or after the first dose of study drug. If medication dates are incomplete and it is not clear whether the medication was concomitant, it will be assumed to be concomitant. Details of prior and concomitant medications will be listed by subject, start date, and verbatim term.
Prior and Concomitant Medications. Prior IBS medications and ongoing (concomitant) medications will be recorded beginning at the signing of the ICF and continuing until the Safety Follow-up call.
Prior and Concomitant Medications. The dosing regimen for oral corticosteroids for treatment of DMD including, but not limited to, prednisolone and prednisone, should be kept the same throughout the study. The following therapies may be used before enrollment and throughout the study; however, the dosage should be constant throughout the treatment period, unless clinically indicated: • Oral ACE inhibitors, including but not limited to perindopril and lisinopril • Oral β-blockers, including but not limited to carvedilol and atenolol • Angiotensin-receptor blockers, including but not limited to losartan, irbesartan, valsartan, and candesartan • Oral laxatives, including but not limited to lactulose, Senokot, and Movicol • Vitamin D and calcium supplements • Alendronate (Fosamax) or other bisphosphonates used to treat osteoporosis/osteopenia by inhibiting osteoclasts • Over-the-counter herbal preparations, including herbal supplements, vitamins, minerals, and homeopathic preparations, provided the patient had been on stable doses for 24 weeks before enrollment in this study Other concomitant medications (e.g., vitamins or other non-RNA antisense medications) may also be taken if, in the opinion of the Investigator, they do not interfere with study assessments and outcomes. The Investigator should contact the Medical Monitor if he/she is unsure of the impact of a concomitant medication on study assessments and outcomes. Every attempt should be made to keep the dosage constant throughout the study period (i.e., through Week 96); although modifications to accommodate changes in weight are permitted. Introduction of new physiotherapy interventions during the course of the study must be avoided unless the best interests of the patient are at risk. Should a contracture develop during the course of the study, and it is considered in the best interest of the patient to treat the contracture, then any of the following interventions may be used to reduce the contracture, but they must be clearly documented: • Contracture control devices • Night splints • Stretching exercises (passive, active, self) • Serial casting The following therapies are not permitted during the conduct of this study: • Systemic or oral steroids for non-DMD conditions • Investigational agents for the treatment of DMD • Any medication with the potential to affect muscle mass, strength, and/or function, such as, but not limited to, growth hormone and PDE-5 inhibitors • Immunosuppressants (other than oral or systemic corticosteroids, ...
