TOZ-CL06 Tozadenant in patients with Parkinson's Disease
Research type
Research Study
Full title
A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose “Wearing-Off”
IRAS ID
222773
Contact name
Antero Kallio
Contact email
Sponsor organisation
Biotie Therapies Inc
Eudract number
2016-003961-25
Clinicaltrials.gov Identifier
33956, CPMS
Duration of Study in the UK
2 years, 11 months, 15 days
Research summary
This is a Phase 3, international, multicenter, open-label study in levodopa-treated patients with PD experiencing end of dose “wearing off”. The objective of the study is to assess the long term safety and tolerability of tozadenant in PD patients.
The study includes a Screening Period of up to 6 weeks that starts with a Screening Visit, followed by a 52 week Open Label Treatment Period and a Safety Follow Up Visit 4 weeks after completion of investigational treatment. Patients will return to the study site for evaluation at scheduled visits at Baseline then Weeks 2, 6, 12, 24, 36, and 52. All patients will receive a dose of 120 mg BID. Adjustments to the dose are allowed after Week 2 and at any of the subsequent visits. Doses of 60 or 120 mg BID are permitted; the investigator may adjust a patient’s dose to either level as clinically indicated. Patients’ concomitant anti PD medications may be adjusted as needed under the investigator’s supervision.
Safety data will be provided to the Data and Safety Monitoring Board (DSMB), at a frequency specified by the DSMB charter, for ongoing monitoring of safety and detection of any trends.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0116
Date of REC Opinion
4 Apr 2017
REC opinion
Further Information Favourable Opinion