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Found 17 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.
Actively Recruiting
Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.
Actively Recruiting
Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.
Actively Recruiting
Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.
Actively Recruiting
Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.
Actively Recruiting
Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.
Actively Recruiting
Researchers are evaluating IMVT-1402 in a global, randomized, double-blind, placebo-controlled Phase 2b study for adults with Graves disease GD who remain hyperthyroid despite antithyroid drug ATD treatment. The study aims to assess the efficacy, safety, and tolerability of IMVT-1402 in this population. Participants will receive one of two doses of IMVT-1402 or a placebo for 26 weeks. The study includes two experimental groups with different doses of IMVT-1402 and a placebo comparator group. Treatments are given over the same 26-week period to evaluate their effects. During the study, participants will be monitored to see if they become euthyroid and are able to stop ATD by Week 26. Researchers will measure thyroid hormone levels such as triiodothyronine T3 and free thyroxine FT4 at various time points, including Weeks 2, 4, and 26. Safety and tolerability will also be assessed throughout the trial, which is expected to complete in May 2027.
Actively Recruiting
Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.
Actively Recruiting
This trial investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.
Actively Recruiting
Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.
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