Clinical Trials Logo
  1. Home
  2. Idiopathic Parkinson's Disease
  3. NCT02453386

Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients — TOZ-PD  

Idiopathic Parkinson's Disease Clinical Trial

Official title:
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)

Clinical Trial Summary

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).

Clinical Trial Description

During Part A, each patient will participate for up to 30 weeks, which includes a Screening Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind treatment:

- Screening Period: 1 - 6 weeks.

- Double-Blind Treatment Period: 24 weeks.

After completion of Part A, patients will continue in Part B for an additional 56 weeks:

- Open-Label Treatment Period: 52 weeks.

- Post-Treatment Safety Follow Up: 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02453386
Study type Interventional
Source Biotie Therapies Inc.
Contact
Status Terminated
Phase Phase 3
Start date July 2015
Completion date January 12, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03665493 - Dopamine Effect on Inhibitory Control N/A
Completed NCT02227355 - Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease N/A
Completed NCT01026428 - A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics Phase 1/Phase 2
Completed NCT00664157 - Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus N/A
Completed NCT04524143 - The Acute Effect of Cervical Mobilization in Parkinson's Disease N/A
Completed NCT05107531 - Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing
Completed NCT04524182 - The Acute Effect of Lumbosacral Mobilization in Parkinson's Disease N/A
Completed NCT00985517 - Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease Phase 1/Phase 2
Completed NCT01968031 - A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease Phase 3
Completed NCT01970813 - Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease N/A
Completed NCT01221948 - Vercise Implantable Stimulator for Treating Parkinson's Disease Phase 2
Terminated NCT01028586 - MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) Phase 3
Completed NCT00239564 - Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease Phase 1/Phase 2
Completed NCT02240030 - Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes Phase 3
Completed NCT00605683 - MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Phase 3
Completed NCT00400634 - Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease Phase 2
Completed NCT01227265 - Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) Phase 3
Completed NCT02565628 - PF-06669571 In Subjects With Idiopathic Parkinson's Disease Phase 1
Completed NCT01617135 - Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes Phase 2
Completed NCT01606670 - Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease