Clinical trial NCT01283594: Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 420
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-parkinson medications
* Are able to complete a Parkinson's disease diary
* If of childbearing potential(male and female), use an acceptable method of birth control
* Able and willing to sign an IRB/IEC approved informed consent
* Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.

Exclusion Criteria:

* Secondary or atypical Parkinson's
* Neurosurgical intervention for Parkinson's disease
* Treatment with apomorphine
* Treatment with anti-psychotic drugs
* Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
* MMSE less than 26
* Subjects with untreated or uncontrolled current episode of major depression
* Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \<100mg per day)
* Women pregnant or lactating
* History of hepatitis, cholangitis
* Untreated or uncontrolled hypothyroidism or hyperthyroidism
* Drops in blood pressure requiring medication to maintain blood pressure
* Any clinically significant out of range laboratory evaluations
* Known sensitivity to the study medication or its components
* Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
* Finding of malignant melanoma on full body skin exam
* Impulse disorder conditions

Primary outcomes:
measure: Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess the effect of SYN115 on dyskinesia
timeFrame: 12 weeks
measure: To assess the effect of SYN115 on UPDRS scores
timeFrame: 12 weeks
measure: To assess investigator and patient impressions of PD severity and change
timeFrame: 12 weeks
measure: To assess the effect of SYN115 on non motor symptoms of PD
timeFrame: 12 weeks
measure: To assess the safety and tolerability of SYN115
timeFrame: 12 weeks
measure: To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oxnard
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Manchester
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: West Bloomfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Commack
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Roanoke
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Santa Fe
country: Argentina
city: Edmonton
country: Canada
state: Alberta
city: Halifax
country: Canada
state: Nova Scotia
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Valdivia
country: Chile
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Timisoara
country: Romania
city: Târgu-Mureş
country: Romania
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Biotie Therapies Inc.
name: Steve Bandak, MD
role: STUDY_CHAIR
affiliation: Biotie Therapies Inc.
name: Ann Neale, RN
role: STUDY_DIRECTOR
References:
citation: Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.