Clinical trial NCT01603069: A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
Official title: A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Safety
Tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 51
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: This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a blinded and randomized assignment. The main objective is to see if safety and tolerability of the drug is acceptable.

Detailed description: A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients with Parkinson's Disease

Eligibility criteria: Inclusion Criteria:

* Each patient must be able and willing to provide signed and dated informed consent prior to the study.
* Female and male patients aged 30 to 80 years at the day of enrollment (Visit 1).
* Patients must meet the criteria for "Diagnosis of idiopathic Parkinson's disease" according to the UKPDS Brain Bank criteria (Hughes et al 1992).
* Have a modified Hoehn and Yahr stage 1-2.5.
* Having no treatment for Parkinson's disease and have no need to add anti-Parkinson's disease treatment during the 14 weeks of study OR are on stable anti-Parkinson's disease medication.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases.
* Have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-Parkinson's disease conditions.
* Presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the UPDRS.
* Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
* Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (GI) disease, or other major disease as judged by the investigator.

Primary outcomes:
measure: Change from baseline in vital signs.
timeFrame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
measure: Change from baseline in Physical Exam results.
timeFrame: Baseline and 2 weeks after termination of treatment (week 14)
measure: Change from baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS).
timeFrame: screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
measure: Adverse events (AEs) including frequency and severity.
timeFrame: Screening, randomization, week 1, 2, 4, 8, 12, 14
measure: Change from baseline in laboratory safety assessments.
timeFrame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
measure: Change from baseline in 12-lead ECG.
timeFrame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
Secondary outcomes:
measure: Pharmacokinetics (PK) of AZD3241 in the terms of Cmax, Cmin, and AUC0-t.
timeFrame: Randomization and after week 1, 2, 4, 8, and 12 weeks of treatment
measure: Pharmacodynamic effect of AZD3241 in the terms of Myeloperoxidase (MPO) activity in plasma.
timeFrame: Screening (baseline), randomization, after, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Long Beach
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Bingham Farms
country: United States
facility: Research Site
state: Michigan
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Marlton
country: United States
facility: Research Site
state: New Jersey
Study officials:
affiliation: AZ Neuro
name: Joel Posener, MSD
role: STUDY_DIRECTOR
References: