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.
A Phase 2a Open-Label Study of CNSA-001 in Patients with Parkinson’s Disease
Censa Pharmaceuticals Australia Pty Ltd
6 participants
Jul 28, 2020
Interventional
Conditions
Summary
This is a single-site phase 2 open-label study to assess the effects of CNSA-001 in patients with Parkinson’s Disease who need adjunctive treatment in combination with levodopa. The study will enroll approximately 6 patients. The total study duration is up to 65 days, which includes a 21-day screening window, 14 days of treatment with CNSA-001 and a 30-day follow up period.
Eligibility
Inclusion Criteria6
- Confirmed diagnosis of Parkinson’s Disease
- Males and females greater than or equal to 18 years
- 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
- 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.
- 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.
- The patient is willing to refrain from tobacco use
Exclusion Criteria9
- Weight > 110 kg
- Diagnosis of functional (psychogenic) movement disorders
- Significant chronic medical illness other than Parkinson’s Disease
- Gastrointestinal disease that could affect absorption of the study drug
- History of gastric surgery, including Roux-en-Y gastric bypass surgery or an antrectomy with vagotomy, or gastrectomy
- Inability to tolerate oral medication
- Any medical condition or history that would prohibit the patient from completing a MRI
- History of surgical intervention for Parkinson’s Disease
- Currently taking an antifolate including, but not limited to, methotrexate, pemetrexed, or trimetrexate
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Interventions
This is a Phase 2 open-label study to assess the safety and tolerability of oral doses of 60 mg/kg CNSA-001 in patients with Parkinson's Disease who may need additional therapy to levodopa. Eligible patients will take CNSA-001 daily with food for 14 days. Patients will be given a dosing diary to record all doses taken at home. Patients will also be asked to return all used dosing bottles to confirm compliance. Following the completion of dosing, three follow-up visits will be conducted by phone on 1-3 days after the last dose, 7-10 days after the last dose, and 30 days after the last dose.
Locations(1)
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ACTRN12620000671965