Study to Evaluate SYN115 in Parkinson's Disease

Biotie Therapies

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: Tozadenant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605553

SYN115-CL01

Details and patient eligibility

About

This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.

Full description

This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.

Enrollment: 30 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Parkinson's disease
• Hoen and Yahr stage 1-3
• On stable dose of anti-parkinsons treatment for 30 days prior to screening
• Age 40 to 75 years
• Sign an IRB approved informed consent
• Men and women agree to use adequate birth control
• ECG measurements are within normal limits
• Able to understand study requirements

Exclusion criteria

• Secondary Parkinson's (drug induced or post stroke)
• Received treatment with other investigational drug 30 days prior to study entry
• Using disallowed medications
• Significant neurological illness other than Parkinson's
• IQ less than 70 on IQ test
• MMSE score < or = 23
• History of psychosis or on anti-psychotic medication
• Current serious medical illness
• History of substance abuse
• History of head injury with loss of consciousness
• History of brain surgery
• Contraindications to MRI like claustrophobia, metal implants or other implantable devices
• Abnormal liver function tests and/or hepatitis or cholangitis
• Gilberts disease
• Pregnant or nursing
• Known hypersensitivity to SYN115

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

Treatment:

Drug: Tozadenant

2

Placebo Comparator group

Description:

Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control

Treatment:

Drug: Placebo