Clinical trial NCT00442780: Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: early Parkinson's Disease
MOBILE
BIIB014
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.

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.


Eligibility criteria: Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law.
* 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:

* A Mini Mental State Examination (MMSE) score \<26.
* 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.

Primary outcomes:
measure: Number and proportion of subjects with adverse events
timeFrame: up to end of study
measure: Assessment of clinical laboratory parameters.
timeFrame: up to end of study
measure: Assessment of vital signs.
timeFrame: up to end of study
measure: Assessment of ECG parameters.
timeFrame: up to end of study
Secondary outcomes:
measure: Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
timeFrame: up to end of study
measure: Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
timeFrame: up to end of study
measure: Explore the PK/pharmacodynamic relationships for BIIB014.
timeFrame: up to end of study
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Ramat-Gan
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Sites
city: Belgrade
country: Serbia
facility: Research Site
Study officials:
affiliation: Cambridge, MA USA
name: Biogen Idec, MD
role: STUDY_DIRECTOR
References: