Overview
The CTH-300/CTH-301 trials are investigating the safety and effectiveness of an oral, sublingual therapy for patients with Parkinson’s disease who are experiencing motor symptoms known as OFF episodes.
If you have been diagnosed with Parkinson’s disease, are currently taking medication for Parkinson’s disease and experience at least one OFF episode per day, you may be eligible to participate in these trials.
View eligibility requirements here.
What is the significance of these trials?
The standard of care for the symptomatic treatment of Parkinson’s disease is levodopa, which was a drug approved specifically for Parkinson’s disease nearly 50 years ago.
However, levodopa has several limitations:
- Levodopa has a short half-life in the body and this half-life decreases as the disease progresses, resulting in the need for more frequent dosing for patients over time
- Levodopa is transported from the gastrointestinal tract into the blood. Patients with Parkinson’s disease experience impaired gastric motility, resulting in fluctuating and unpredictable levels of levodopa
- Absorption of levodopa in the gastrointestinal tract is limited when taken orally with foods (particularly foods high in protein)
The unreliability of oral levodopa results in periods of time when symptoms return, referred to as an OFF episode. One drug, apomorphine, is available by injection for the treatment of OFF episodes.
The CTH-300/CTH-301 trials are designed to determine whether a sublingual formulation of apomorphine delivered by absorption under the tongue is a safe and effective therapy for the treatment of OFF episodes.
Which trials are currently enrolling patients?
There are two Phase 3 trials in progress for the product candidate APL-130277.
The CTH-300 study is a placebo-controlled study for patients with Parkinson’s disease who have at least one OFF episode every day and a total OFF time of at least two hours per day. The objective is to evaluate the efficacy and safety of APL-130277, a sublingual formulation of apomorphine which is currently only approved in the form of a subcutaneous injection in the United States. Patients will be observed for 12 weeks, with dosing at home and in the clinic. Patients will be evaluated every four weeks in the clinic. This study is double blind, so neither patients nor their physician will know if they are taking APL-130277 or a placebo. Following completion of the study, patients may join the CTH-301 trial and receive APL-130277.
Learn more about the CTH-300 trial at ClinicalTrials.gov here.
The CTH-301 study is for patients with Parkinson’s disease with OFF episodes who have at least one OFF episode every day and a total OFF time of at least two hours per day, and will evaluate the safety and tolerability of APL-130277 over a period of six months of treatment.
Learn more about the CTH-301 trial at ClinicalTrials.gov here.