NCT01283594

A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off

Completed Phase 2/Phase 3 Last updated 14 January 2019

What this trial tests

Phase 2/Phase 3 trial testing Tozadenant (SYN115) 60 mg BID in Parkinson's Disease in 420 participants. Completed in 1 October 2012.

Timeline

1 March 2011

Primary endpoint
1 October 2012

1 October 2012

Quick facts

Lead sponsor	Biotie Therapies Inc.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	420
Start date	1 March 2011
Primary completion	1 October 2012
Estimated completion	1 October 2012
Sites	61 locations across United States, Argentina, Canada, Chile, Romania, Ukraine

Drugs / interventions tested

• Tozadenant (SYN115) 60 mg BID — full drug profile →
• Placebo
• Levodopa (L-dopa) — full drug profile →
• Tozadenant (SYN115) 120 mg BID — full drug profile →
• Tozadenant (SYN115) 180 mg BID — full drug profile →
• Tozadenant (SYN115) 240 mg BID — full drug profile →

Conditions studied

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

Sponsor

Biotie Therapies Inc. — full company profile →

Who can join

Adults 30 to 80, any sex, with 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.

• Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
  Time frame: 12 weeks

Sponsor's own description

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Publications & conference data

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

1. Adenosine receptors as drug targets--what are the challenges?
   Chen JF, Eltzschig HK, Fredholm BB. · · 2013 · cited 678× · PMID 23535933 · DOI 10.1038/nrd3955
2. Barriers to Radiation-Induced <i>In Situ</i> Tumor Vaccination.
   Wennerberg E, Lhuillier C, Vanpouille-Box C, Pilones KA, et al · · 2017 · cited 150× · PMID 28348554 · DOI 10.3389/fimmu.2017.00229
3. Adenosine A1 and A2A Receptors in the Brain: Current Research and Their Role in Neurodegeneration.
   Stockwell J, Jakova E, Cayabyab FS. · · 2017 · cited 142× · PMID 28441750 · DOI 10.3390/molecules22040676
4. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial.
   Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, et al · · 2014 · cited 98× · PMID 25008546 · DOI 10.1016/s1474-4422(14)70148-6
5. Adenosine A(2A) Receptor Antagonists and Parkinson's Disease.
   Shook BC, Jackson PF. · · 2011 · cited 70× · PMID 22860156 · DOI 10.1021/cn2000537
6. 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
7. Purinergic signaling: A gatekeeper of blood-brain barrier permeation.
   Wang Y, Zhu Y, Wang J, Dong L, et al · · 2023 · cited 27× · PMID 36825149 · DOI 10.3389/fphar.2023.1112758
8. Pathophysiological Role and Medicinal Chemistry of A_2A Adenosine Receptor Antagonists in Alzheimer's Disease.
   Merighi S, Borea PA, Varani K, Vincenzi F, et al · · 2022 · cited 17× · PMID 35566035 · DOI 10.3390/molecules27092680