- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451815
BIIB014 Phase 2a Monotherapy
August 21, 2023 updated by: Biogen
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson's Disease
To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in subjects with early PD.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the Baseline Visit (Day -1):
- Must give written informed consent. Must also provide all authorizations required by local law.
- Aged 30 to 78 years old at the time of informed consent.
- If female, must be postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded.
- Carry a diagnosis of probable idiopathic PD, made by a Movement Disorder Specialist, with asymmetric onset and at least 2 of the following cardinal features of PD: bradykinesia, rigidity, or a classic PD resting tremor.
- Be Hoehn & Yahr Stage I-III inclusive when OFF.
- Have a Total Unified PD Rating Scale (UPDRS) OFF score of ³ 8.
- Have taken no prescribed medications for PD for a minimum of 2 weeks before the Baseline Visit (Day -1).
- Are willing to abstain from alcohol for the duration of the study.
- Have no clinically significant baseline ECG (12-lead) and laboratory abnormalities (as determined by the Investigator), unless exempted by the Biogen Idec Medical Director.
- Agree to provide blood samples for mRNA and DNA analysis, which will be collected and banked and may be used for exploratory pharmacogenomic studies.
Exclusion Criteria
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Baseline Visit (Day -1):
- Mini Mental State Examination (MMSE) score <27.
- History or clinical features such as impaired downward gaze, prominent axial rigidity, gait initiation failure, autonomic dysfunction, etc. consistent with an atypical parkinsonism syndrome.
- Any significant non-PD central nervous system disorder.
- Significant AXIS I psychiatric disease as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition-Revised (DSM IV-TR, American Psychiatric Association, 2000).
- History of surgical intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.).
- Participation in a previous adenosine A2A trial.
- Participation in any other investigational drug study within 1 month prior to randomization into this trial.
- History of malignancy unless an exemption has been granted by the Biogen Idec Medical Director.
- History of severe allergic or anaphylactic reactions to a drug.
- Clinically significant cardiac, renal, pulmonary, hematopoietic, endocrine, or hepatic disease.
- Abnormal laboratory results as follows: AST, ALT, total bilirubin, GGT levels > 1.5 x upper limit of normal; serum lipase > upper limit of normal; WBC < 4,000 cells/mm3 hemoglobin < 10, or any other abnormal laboratory value that could interfere with the assessment of safety.
- Supine (measured in duplicate 10 minutes after resting) or standing (measured in duplicate 3 minutes after changing from a supine to a standing position) blood pressure of >150 or <90 mmHg systolic or >90 or <40 mmHg diastolic on 2 consecutive occasions.
- Orthostatic hypotension as defined by a decrease in systolic BP of >20 mmHg or in diastolic blood pressure of > 10 mmHg measured in duplicate 3 minutes after changing from a supine to standing position.
- History of human immunodeficiency virus (HIV).
- Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- History of drug or alcohol abuse as defined by the DSM IV-TR (American Psychiatric Association, 2000) within 1 year prior to randomization into this trial.
- Alcohol use within 72 hours of Baseline Visit (Day -1).
- Donation of blood or plasma in excess of 500 mL within 3 months of the Screening Visit.
- Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- Any other reasons that, in the opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Biogen Idec, Biogen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
March 23, 2007
First Posted (Estimated)
March 26, 2007
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Antagonists
- Purinergic Agents
- Purinergic P1 Receptor Antagonists
- Adenosine A2 Receptor Antagonists
- 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine
Other Study ID Numbers
- 204-PD-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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