An open-label study of combination therapy of CNSA-001 with levodopa in patients with Parkinson's Disease for the treatment of motor and non-motor symptoms of Parkinson's Disease.
- Conditions
- Parkinson's DiseaseNeurological - Parkinson's disease
- Registration Number
- ACTRN12620000671965
- Lead Sponsor
- Censa Pharmaceuticals Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 6
Key inclusion criteria include:
1.Confirmed diagnosis of Parkinson’s Disease
2.Males and females greater than or equal to 18 years
3.Females must be either postmenopausal for at least 1 year, or surgically sterile for at least 6 months or, if of childbearing potential and not abstinent, willing to use a combination method of contraception from screening through 30 days after the last dose of study drug
4.Males (if sexually active and nonsterile) with female partners of childbearing potential must agree to use barrier contraceptive with spermicidal foam from screening through 90 days after the last dose of study drug.
5.The patient is clinically stable on therapy for management of Parkinson’s Disease, on a stable dose of levodopa or dopamine replacement equivalent medication, but needs more levodopa or dopamine replacement equivalent to control disease.
6.The patient is willing to refrain from tobacco use
Key exclusion criteria include:
1.Weight > 110 kg
2.Diagnosis of functional (psychogenic) movement disorders
3.Significant chronic medical illness other than Parkinson’s Disease
4.Gastrointestinal disease that could affect absorption of the study drug
5.History of gastric surgery, including Roux-en-Y gastric bypass surgery or an antrectomy with vagotomy, or gastrectomy
6.Inability to tolerate oral medication
7.Any medical condition or history that would prohibit the patient from completing a MRI
8.History of surgical intervention for Parkinson’s Disease
9.Currently taking an antifolate including, but not limited to, methotrexate, pemetrexed, or trimetrexate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the safety and tolerability of multiple oral daily doses of CNSA-001 60 mg/kg with food[Vital signs, physical examinations, and adverse events will be collected at Screening, Day 1, Day 2, and Day 14. Adverse events will be monitored as well on each of the phone follow-up visits. <br><br>Clinical safety laboratory tests will be collected at Screening, Day 1, and Day 14. ]
- Secondary Outcome Measures
Name Time Method