Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00442780

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: BIIB014 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Number and proportion of subjects with adverse events [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
Assessment of clinical laboratory parameters. [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
Assessment of vital signs. [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
Assessment of ECG parameters. [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma. [ Time Frame: up to end of study ] [ Designated as safety issue: No ]
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments. [ Time Frame: up to end of study ] [ Designated as safety issue: No ]
Explore the PK/pharmacodynamic relationships for BIIB014. [ Time Frame: up to end of study ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	August 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Dose Level A of BIIB014	Drug: BIIB014 oral administration of BIIB014 per dose, schedule,and duration specified in protocol Drug: Placebo Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
2: Placebo Comparator Dose Level B of BIIB014	Drug: BIIB014 oral administration of BIIB014 per dose, schedule,and duration specified in protocol Drug: Placebo Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
3: Placebo Comparator Dose Level C of BIIB014	Drug: BIIB014 oral administration of BIIB014 per dose, schedule,and duration specified in protocol Drug: Placebo Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
4: Placebo Comparator Dose Level D of BIIB014	Drug: BIIB014 oral administration of BIIB014 per dose, schedule,and duration specified in protocol Drug: Placebo Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442780

Locations

Israel
Research Site
Tel Aviv, Israel
Research Site
Petach Tikva, Israel
Research Site
Ramat-Gan, Israel
Research Site
Ashkelon, Israel
Poland
Research Site
Krakow, Poland
Research Site
Warszawa, Poland
Research Site
Kielce, Poland
Research Site
Poznan, Poland
Serbia
Research Sites
Belgrade, Serbia
Research Site
Belgrade, Serbia

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec, MD

Cambridge, MA USA

More Information

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	204PD203, EUDRA CT NO: 2007-000398-47
Study First Received:	March 1, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00442780 History of Changes
Health Authority:	Israel: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Biogen Idec:

early Parkinson's Disease
MOBILE
BIIB014

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010