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The adverse effects found in the Phase II trial mainly affected the central nervous system, and appeared to be dose-related. [8] The most common adverse effects were drowsiness, dizziness, tinnitus and vertigo, confusion, and slurred speech. [9] Less common side effects included tremor, memory loss, gait disturbances, and double vision. [10]
Neramexane is a drug related to memantine, [1] which acts as an NMDA antagonist [2] and has neuroprotective effects. [3] It is being developed for various possible applications, including treatment of tinnitus, [4] [5] Alzheimer's disease, [6] drug addiction [7] and as an analgesic. [8]
In 2020, information about clinical trials indicated that bimodal neuromodulation may reduce the symptoms of tinnitus. It is a noninvasive technique that involves applying an electrical stimulus to the tongue while also administering sounds. [129] Equipment associated with the treatments is available through physicians.
One trial with good methods showed no effect of betahistine on tinnitus compared with placebo in 35 patients. None of the trials showed any effect of betahistine on hearing loss. No serious adverse effects were found with betahistine." Betahistine is also undergoing clinical trials for the treatment of attention deficit hyperactivity disorder ...
Established in 1868, the Canadian Pharmacists Journal (CPJ) is Canada's oldest continuously published periodical.This peer-reviewed journal is published 6 times per year. It features original research, clinical reviews, commentaries, evidence briefs, clinical practice guidelines and practice tools relating to advancing pharmacy practice towards patient-centred care and improving outcomes.
Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.
Since 1980, the organization has granted around $6 million in seed funding for tinnitus research. [7] Many of the researchers have utilized their ATA-funded research data to apply for and receive larger, federally-funded grants from the Department of Defense, National Science Foundation, and the National Institute on Deafness and Other Communications Disorders (NIDCD), part of the NIH.
In Canada, a Clinical Trial Application (CTA) must be filed with the Health Products and Food Branch (HPFB) of Health Canada before starting a clinical trial. If the clinical trial results show that therapeutic effect of the drug outweighs negative side effects then the sponsor can then to file a New Drug Submission. [4]
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