Systematically Testing the Evidence on Marijuana

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema. Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study. We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD. Eligible participants undergo the following tests and procedures: Medical family and medication history Skin examination Blood tests (research blood as well as serum IgE, and complete blood count) Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter. Nose swabs to analyze microbes. Patients with eczema may have photographs of their skin taken to help monitor the skin rashes. Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.

First Posted: January 31, 2008

Condition(s): Atopic Dermatitis, Eczema, Ichthyosis Vulgaris

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 530

Allocation:

Sponsor: National Human Genome Research Institute (NHGRI)

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT00605878

The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added. Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

First Posted: December 4, 2006

Condition(s): Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases, Brain Diseases

Intervention(s): Preladenant, Preladenant, Preladenant, Preladenant, Placebo, L-dopa, Other Parkinson's Disease treatments

Status: Completed

Enrollment (expected or actual): 253

Allocation: Randomized

Sponsor: Merck Sharp & Dohme LLC

Principal Investigator:

Completion Date (primary or actual): October 5, 2008

CT.gov Identifier: NCT00406029