A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01603069
• Date of registration: 14/05/2012
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
• Scientific 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
• Date of first enrolment: October 2012
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01603069
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joel Posener, MSD
• Affiliation: AZ Neuro

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: AZD3241 300 mg BID

Drug: Placebo

Drug: AZD3241 600 mg BID

Primary Outcome(s)

Adverse events (AEs) including frequency and severity. [Time Frame: Screening, randomization, week 1, 2, 4, 8, 12, 14]

Change from baseline in laboratory safety assessments. [Time Frame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)]

Change from baseline in vital signs. [Time Frame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)]

Change from baseline in Physical Exam results. [Time Frame: Baseline and 2 weeks after termination of treatment (week 14)]

Change from baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS). [Time Frame: screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)]

Change from baseline in 12-lead ECG. [Time Frame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)]

Secondary Outcome(s)

Pharmacodynamic effect of AZD3241 in the terms of Myeloperoxidase (MPO) activity in plasma. [Time Frame: Screening (baseline), randomization, after, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)]

Pharmacokinetics (PK) of AZD3241 in the terms of Cmax, Cmin, and AUC0-t. [Time Frame: Randomization and after week 1, 2, 4, 8, and 12 weeks of treatment]

Secondary ID(s)

D0490C00005

EudraCT number: 2012-001313-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors