NCT02453386: TOZ-PD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

Terminated Phase 3 Results posted Last updated 25 March 2019

What this trial tests

Phase 3 trial testing tozadenant in Idiopathic Parkinson's Disease in 449 participants. Terminated before completion.

Timeline

1 July 2015

Primary endpoint
12 January 2018

12 January 2018

Quick facts

Lead sponsor	Biotie Therapies Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	449
Start date	1 July 2015
Primary completion	12 January 2018
Estimated completion	12 January 2018
Sites	71 locations across United States, Austria, Canada, Czechia, Germany, Italy, Spain

Drugs / interventions tested

• tozadenant — full drug profile →
• placebo

Conditions studied

• Idiopathic Parkinson's Disease — all drugs for Idiopathic Parkinson's Disease →

Sponsor

Biotie Therapies Inc. — full company profile →

Who can join

Adults 30 to 80, any sex, with Idiopathic Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
  Time frame: Baseline to 24 Weeks
  Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days

Sponsor's own description

Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motor Complications of Dopaminergic Medications in Parkinson's Disease.
   Freitas ME, Hess CW, Fox SH. · · 2017 · cited 83× · PMID 28511255 · DOI 10.1055/s-0037-1602423
2. Novel targeted therapies for Parkinson's disease.
   Ntetsika T, Papathoma PE, Markaki I. · · 2021 · cited 78× · PMID 33632120 · DOI 10.1186/s10020-021-00279-2
3. Targeting Adenosine Signaling in Parkinson's Disease: From Pharmacological to Non-pharmacological Approaches.
   Nazario LR, da Silva RS, Bonan CD. · · 2017 · cited 29× · PMID 29217998 · DOI 10.3389/fnins.2017.00658
4. Soluble Epoxide Hydrolase Inhibition to Face Neuroinflammation in Parkinson's Disease: A New Therapeutic Strategy.
   Pallàs M, Vázquez S, Sanfeliu C, Galdeano C, et al · · 2020 · cited 28× · PMID 32369955 · DOI 10.3390/biom10050703
5. Receptor Ligands as Helping Hands to L-DOPA in the Treatment of Parkinson's Disease.
   Del Bello F, Giannella M, Giorgioni G, Piergentili A, et al · · 2019 · cited 23× · PMID 30970612 · DOI 10.3390/biom9040142
6. Adenosine receptors as promising targets for the management of ocular diseases.
   Spinozzi E, Baldassarri C, Acquaticci L, Del Bello F, et al · · 2021 · cited 13× · PMID 33519168 · DOI 10.1007/s00044-021-02704-x
7. Drug Development for Alzheimer's and Parkinson's Disease: Where Do We Go Now?
   Sequeira L, Benfeito S, Fernandes C, Lima I, et al · · 2024 · cited 12× · PMID 38931832 · DOI 10.3390/pharmaceutics16060708
8. Synthesis and Biological Evaluation of a Novel ¹⁸F-Labeled Radiotracer for PET Imaging of the Adenosine A_2A Receptor.
   Lai TH, Toussaint M, Teodoro R, Dukić-Stefanović S, et al · · 2021 · cited 8× · PMID 33504051 · DOI 10.3390/ijms22031182