Parkinson's DiseasePhase 2NCT00451815
BIIB014 Phase 2a Monotherapy
A Phase 2 study testing active drug (BIIB014) at 10, 30, 100, or 300 mg once daily. in people with Parkinson's Disease, run by Biogen.
Trial summary
To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in subjects with early PD. Read more about this study
- Who is it for?
- Ages 30 to 78 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.).
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- 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.
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Being tested
- active drug (BIIB014) at 10, 30, 100, or 300 mg once daily., placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.Drug
placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biogen Idec, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451815
- Sponsor's protocol ID
- 204-PD-201
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2006
- Last updated
- 23 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00451815
- Acronym / sponsor ID
- 204-PD-201
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- First posted
- 26 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in subjects with early PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 30 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active drug (BIIB014) at 10, 30, 100, or 300 mg once daily. | Drug | – |
| placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biogen Idec study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing active drug (BIIB014) at 10, 30, 100, or 300 mg once daily. in people with Parkinson's Disease, run by Biogen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.