Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

Biotie Therapies

Status and phase

Terminated

Phase 3

Conditions

Idiopathic Parkinson Disease

Treatments

Drug: Tozadenant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03051607

TOZ-CL06

Details and patient eligibility

About

Phase 3, international, multicenter, open-label 12 month safety study.

Full description

Each patient will participate for up to 52 weeks, which includes a Screening Period, followed by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after the last treatment.

Screening Period: up to 6 weeks.
Open-Label Treatment Period: 52 weeks (1 year)
Post-Treatment Safety Follow Up: 4 weeks.

Enrollment

66 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
Minimum of 3 years since diagnosis.
Meet Hoehn and Yahr PD stage
Good response to levodopa
Stable regimen of anti-PD medications
Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
Patient has documented a minimum amount of Off time.
If of childbearing potential (male and female) must use an acceptable method of contraception

Exclusion criteria

Previous tozadenant study participation
Current or recent participation in another study.
Secondary or atypical parkinsonism
Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening)
Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
Treatment with excluded medications
Untreated or uncontrolled hyperthyroidism or hypothyroidism
Clinically significant out-of-range laboratory
MMSE out of range
Current episode of major depression (stable treatment for depression is permitted).
Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Women lactating or pregnant
Hypersensitivity to any components of tozadenant or excipients
Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
History of hepatitis or cholangitis