Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease (MOBILE)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00442780
First received: March 1, 2007
Last updated: January 8, 2009
Last verified: January 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Placebo Comparator: 1
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
Placebo Comparator: 2
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
Placebo Comparator: 3
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
Placebo Comparator: 4
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
Ashkelon, Israel
Research Site
Petach Tikva, Israel
Research Site
Ramat-Gan, Israel
Research Site
Tel Aviv, Israel
Poland
Research Site
Kielce, Poland
Research Site
Krakow, Poland
Research Site
Poznan, Poland
Research Site
Warszawa, 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 MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00442780     History of Changes
Other Study ID Numbers: 204PD203, EUDRA CT NO: 2007-000398-47
Study First Received: March 1, 2007
Last Updated: January 8, 2009
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:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 22, 2014