We recently completed an open-label pilot study of gabapentin for troublesome tinnitus. Between November 2001 and April 2002, 19 patients were placed on 900 mg per day of gabapentin. The goal of this study was to assess the role of gabapentin in the treatment of tinnitus. We conducted a double-blind placebo-controlled randomized clinical trial. Eligible subjects completed the following American Tinnitus Association data collection forms and questionnaires: tinnitus description and history, medical and health information, and hearing history and occupational exposure. Effect of Gabapentin on Idiopathic Subjective Tinnitus. Herein, we propose an open-label pilot study investigating the effectiveness of rTMS stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and attention, in the treatment of tinnitus Read More.
Previous pilot studies researching the use of DBS in Alzheimer’s have indicated the potential to slow cognitive decline in some patients, and have even shown metabolic changes in the brain that may slow the progression of the disease. We are pleased to initiate the clinical development of OTO-311 for tinnitus with the dosing of the first subjects in our Phase I clinical safety trial, said David A. We expect to complete this trial in the first half of 2016, and initiate a Phase II trial in tinnitus patients during the second half of the year. This international trial is an open-label, intrapatient, dose-escalation study designed to assess the safety, tolerability, immunogenicity, and activity of Resolaris in adult patients with LGMD2B. In this review we discuss the evidence underlying the commonly used non-hormonal therapies for hot flushes in terms of efficacy and safety. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial.
Several drugs were studies in open-label and uncontrolled trials. (2001) Drug-resistant cluster headache responding to gabapentin: a pilot study. Therefore, we decided to develop a novel clinical guideline. Available evidence suggests that the three-step strategy is effective without troublesome adverse events, and the two-step strategy is more effective than the three-step strategy, but with more adverse events. Furthermore, another open-label, randomized controlled trial demonstrated that the addition of oral ketorolac to regular morphine therapy showed an insignificant but better analgesic effect compared with morphine only (54). Another small, observational trial evaluating the efficacy of clonazepam as an adjuvant to opioids in cancer patients with neuropathic pain demonstrated that although the mean pain intensity decreased from three to one in five patients who completed the study protocol, another five patients dropped out because of worsening pain or drowsiness (77).