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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of BMS-986368, a FAAH/MAGL inhibitor, on spasticity in people with Multiple Sclerosis (MS). This Phase 2 study aims to assess the drug's efficacy, safety, and tolerability by comparing three different doses of BMS-986368 to a placebo in participants who have experienced MS-related spasticity for at least six months. Participants will receive oral doses of BMS-986368 or placebo at specified times. The study includes four groups: three groups receive different doses of BMS-986368, and one group receives a placebo. Treatment is administered according to a set schedule, and the trial is conducted at multiple centers with a double-blind design to ensure unbiased results. During the study, participants' spasticity levels will be measured using the Total Numeric-transformed Modified Ashworth Scale focusing on the most affected lower limb at week 6. Additional evaluations include safety and tolerability assessments. Participants are monitored throughout the treatment period for changes in spasticity and any side effects. The study includes adults aged 18 to 70 years with specific MS-related disability and spasticity criteria.
Actively Recruiting
This research focuses on people with progressive pulmonary fibrosis or idiopathic pulmonary fibrosis (IPF) who have already completed a previous Avalyn Pharma study involving an inhaled antifibrotic medication, such as AP01. The trial aims to evaluate the long-term safety and tolerability of Avalyn's inhaled antifibrotic drug over an average of 6 years. It is an open-label extension study where all participants continue receiving treatment after their initial study completion. Participants will receive 100 mg of pirfenidone inhalation solution (AP01) twice daily through the eFlow Nebulizer System. The study includes a Screening/Baseline Visit, an open-label Treatment Period where the study drug is administered, and a Follow-up/End of Study phone call about two weeks after the last dose. Participants will start this extension on the same day they complete their previous study's final dose. During the study, adherence will be tracked using a paper dosing diary and by collecting any unused medication. Assessments include safety and tolerability monitoring throughout the long-term treatment period. The total participation lasts through the end of the study, with follow-up calls to evaluate ongoing safety after treatment ends.