Lintgen, Luxembourg

  • The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

    This is a phase III multicenter study designed to assess the efficacy and the safety of Bonjesta in the treatment of NVP in pregnant adolescents from approximately 14-16 study sites in the United States. After obtaining informed consent on Day 1 (i.e., baseline visit), a medical examination will be conducted to ensure eligibility. Participants will be randomized to receive either Bonjesta or placebo. On Day 1, all participants will take 1 tablet of study drug at bedtime. On Day 2, participants will take 1 tablet of study drug at bedtime. If the Pregnancy-Unique Quantification of Emesis (PUQE) score > 3, the participant will take another tablet of study drug in the morning of Day 3. Therefore, the minimum dosage will be 1 tablet daily at bedtime, increasing, when indicated (i.e., if PUQE > 3), to the maximal dosage of 2 tablets per day on Days 3 to 14. Participants will be required to complete a diary daily to assess the severity of their NVP using the validated PUQE scale and to record any adverse events (AEs) experienced; the Global Assessment of Well-being scale will also be completed in the diary only on Days 1, 8 and 15. Participants will receive telephone calls daily to assess whether the current dosing regimen is sufficient at relieving NVP symptoms, to review study procedures, and to address the participants' questions/concerns. Participants will have study visits on Day 1, Day 3 (±1 day) and Day 15 (±1 day) for an end of study visit.

    Phase

    3

    Span

    296 weeks

    Sponsor

    Duchesnay Inc.

    Burbank, California

    Recruiting

    Healthy Volunteers

  • MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

    In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

    Phase

    N/A

    Span

    512 weeks

    Sponsor

    Vertos Medical, Inc.

    Burbank, California

    Recruiting

  • Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

    The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain. The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

    Phase

    N/A

    Span

    207 weeks

    Sponsor

    Aspira Women's Health

    Burbank, California

    Recruiting

  • A Study of Barzolvolimab in Patients With Atopic Dermatitis

    This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis. There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg [Arm 1], 300 mg Q4W after an initial loading dose of 450 mg [Arm 2], or placebo Q4W [Arm 3]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.

    Phase

    2

    Span

    125 weeks

    Sponsor

    Celldex Therapeutics

    Burbank, California

    Recruiting

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