Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00438607

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 moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).

This study will also explore:

the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (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 Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).

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.

The study will be divided into 2 parts:

Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by
Part B: a parallel-group exploration of the two highest tolerated doses versus placebo.

Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.

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 Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa

Resource links provided by NLM:

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa

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 24h following last dose (Part A only) ] [ Designated as safety issue: No ]
Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments [ Time Frame: up to 8h following last dose (Part A); up to 24h following last dose (Part B only) ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	April 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 BIIB014 at MTD from Part A	Drug: BIIB014 oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
2 BIIB014 at dose immediately below MTD from Part A	Drug: BIIB014 oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
3: Placebo Comparator	Drug: Placebo Matched placebo for MTD or MTD-1

Eligibility

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

Criteria

Inclusion Criteria:

Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria, and be Hoehn & Yahr Stage II to IV (inclusive) when OFF.
Must be on a stable dose of L-3,4-dihydroxyphenylalanine (L-DOPA)/carbidopa or L-DOPA/benserazide for at least 4 weeks prior to enrollment.
Except for L-DOPA and certain allowed dopamine agonists, must not be receiving any other PD medications. (Current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
Some subjects must demonstrate a definite end of L-DOPA dose wearing off (at least 2 hours OFF time per waking day) and must be able to keep accurate patient diaries of PD activity.

Major Exclusion Criteria:

A Mini Mental State Examination (MMSE) score <26.
History or clinical features consistent with an atypical parkinsonian syndrome.
Any significant non-Parkinson's central nervous system disorder.
Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM).
Any previous surgical intervention for Parkinson's Disease.
History of certain malignancies.
History of severe allergic anaphylactic reactions to any drug.
Clinically significant baseline electrocardiogram (ECG).
Orthostatic hypotension.
HbA1c >7.0%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438607

Locations

India
Research Site
Hyderabaad, India
Research Sites
Bangalore, India
Research Site
Chennai, India
Research Site
Secunderabad, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Ludhiana, India
Israel
Research Site
Tel Aviv, Israel
Research Site
Ramat-Gan, Israel
Research Site
Ashkelon, Israel
Research Site
Jerusalem, Israel
United Kingdom
Research Site
Norwich, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Salford, United Kingdom
Research Site
Manchester, United Kingdom

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec

Cambridge, MA USA

More Information

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	204PD202, EUDRA CT NO: 2006-003490-27, ISCRTN 12870393
Study First Received:	February 20, 2007
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00438607 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; India: Ministry of Health; Israel: Ministry of Health

Keywords provided by Biogen Idec:

Moderate to late stage Parkinson's Disease

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