WUH: A randomized double-blind placebo-controlled study of diazoxide choline controlled-relealese tablet (DCCR) in patients with prader-Willi Syndrome.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prader-willi Syndrome
  • Age: Between 4 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are at least 4 years old
    2. Subjects who will provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient) and provide voluntary, written assent (patients, as appropriate)
    3. Subjects with genetically-confirmed Prader-Willi syndrome by methylation analysis
    4. Subjects who scored 13 or greater on the Hyperphagia Questionnaire for Clinical Trials
    5. Subjects who are in stable care setting for at least 6 months
    6. Caregiver must have been caring for the patient for at least 6 months prior to Visit 1 and will care for the patient throughout the study a minimum of 4 waking hours per day
    7. Subjects and caregiver agree to continue the patient on his/her current dietary and physical activity regimens throughout the study
    8. Subjects with a diagnosis of type II diabetes mellitus are adequately managed with anti-diabetic medication(s) other than insulin and no recent history of ketoacidosis or hyperosmolar coma
    9. Subjects on stable regimens of all concomitant chronic medications for at least 3 months prior to Visit 1, except what is listed in the protocol
    10. Subjects who are able to complete all screening assessments and procedures

You may not be eligible for this study if the following are true:

    1. Subjects with weight < 30 kg or =135 kg
    2. Subjects have participated in an interventional clinical study
    3. Subjects with History of allergic reaction or significant intolerance to Diazoxide or Thiazides or Sulfonamides
    4. Subjects who may use within 3 months prior to Visit 1 or anticipated requirement for use at any time during the study of the following prohibited medications:
      • Anti-obesity medications or other medications (including herbal preparations, over-the-counter products) or procedures for weight reduction
      • Medications, including homeopathy and herbal preparations, that are strong inhibitors or inducers of CYP450 1A2 or 3A4
      • Medications known to prolong the QTc interval
      • Systemic steroids
      • Any drugs medications, herbal preparation, homeopathy, nutraceuticals, or procedures (i.e., acupuncture, vagal stimulation), that may have an effect on any study endpoints
      • Use of any investigational drugs or devices
    5. Subjects who anticipate changes in caregiver, care setting or other similarly potentially disruptive changes during participation in the study
    6. Subjects with known type 1 diabetes mellitus
    7. Subjects with uncontrolled hypertension
    8. Subjects with history of thromboembolic events, concurrent treatment for thromboembolic event(s), and/or signs suggestive of a possible thromboembolic event
    9. Subjects with known history of thromboembolic events in a first degree relative
    10. Subjects with Grade 3 or 4 peripheral edema at physical examination or history of severe peripheral edema that could not be managed with an oral diuretic
    11. Subjects who are pregnant or breastfeeding or with positive urine pregnancy test
    12. Subjects with history of torsades de pointes (TdP), congenital long QT syndrome, brady arrythmias, or uncompensated heart failure
    13. Subjects with diagnosis of psychiatric disease or hospitalization for a psychiatric reason within 6 months prior to Visit 1
    14. Subjects with cancer within the past 5 years
    15. Subjects with any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol
    16. Subjects whose primary caregiver cannot read and understand English, or communicate with Investigator and study site personnel



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