NCT01736176 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Standaert DG, Rodriguez RL, Slevin JT, Lobatz M, Eaton S, Chatamra K, Facheris MF, Hall C, Sail K, Jalundhwala YJ, Benesh J
Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease. Mov Disord Clin Pract. 2017 Nov-Dec;4(6):829-837. doi: 10.1002/mdc3.12526. Epub 2017 Sep 20.

An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease

Details for clinical trial NCT01736176

Clinical trial NCT01736176 - References