Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
NCT ID: NCT00442780
Last Updated: 2009-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2007-08-31
2008-12-31
Brief Summary
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This study will also explore:
* How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
* The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study).
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dose Level A of BIIB014
BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
2
Dose Level B of BIIB014
BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
3
Dose Level C of BIIB014
BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
4
Dose Level D of BIIB014
BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
Interventions
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BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
Eligibility Criteria
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Inclusion Criteria
* Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
* Must be modified Hoehn \& Yahr Stage 1 to 2.5 (inclusive).
* Must have a baseline UPDRS (Part III) motor score of at least 10.
* Subjects may be receiving an anticholinergic agent and/or MAO-B inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other PD medication.
Exclusion Criteria
* History or clinical features consistent with an atypical parkinsonian syndrome.
* Any significant non-PD central nervous system disorder.
* Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders.
* History of cognitive or neuropsychiatric conditions.
* History of surgical intervention for PD.
* History of L-DOPA-induced motor or non-motor complication.
* History of malignancy.
* History of severe allergic or anaphylactic reactions to any drug.
* Clinically significant renal dysfunction.
* HbA1c \>7.0%.
* Clinically significant baseline ECG.
* Orthostatic hypotension.
* Treatment with L-DOPA/carbidopa or L-DOPA/benserazide for more than 6 cumulative months at anytime since subject's initial PD diagnosis.
30 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Principal Investigators
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Biogen Idec, MD
Role: STUDY_DIRECTOR
Cambridge, MA USA
Locations
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Research Site
Ashkelon, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Kielce, , Poland
Research Site
Krakow, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Research Sites
Belgrade, , Serbia
Research Site
Belgrade, , Serbia
Countries
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Other Identifiers
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EUDRA CT NO: 2007-000398-47
Identifier Type: -
Identifier Source: secondary_id
204PD203
Identifier Type: -
Identifier Source: org_study_id
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