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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB014
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring early Parkinson's Disease, MOBILE, BIIB014

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Sites
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Dose Level A of BIIB014

Dose Level B of BIIB014

Dose Level C of BIIB014

Dose Level D of BIIB014

Outcomes

Primary Outcome Measures

Number and proportion of subjects with adverse events
Assessment of clinical laboratory parameters.
Assessment of vital signs.
Assessment of ECG parameters.

Secondary Outcome Measures

Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Explore the PK/pharmacodynamic relationships for BIIB014.

Full Information

First Posted
March 1, 2007
Last Updated
January 8, 2009
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00442780
Brief Title
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
Acronym
MOBILE
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

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
early Parkinson's Disease, MOBILE, BIIB014

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Dose Level A of BIIB014
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Dose Level B of BIIB014
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Dose Level C of BIIB014
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Dose Level D of BIIB014
Intervention Type
Drug
Intervention Name(s)
BIIB014
Intervention Description
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
Primary Outcome Measure Information:
Title
Number and proportion of subjects with adverse events
Time Frame
up to end of study
Title
Assessment of clinical laboratory parameters.
Time Frame
up to end of study
Title
Assessment of vital signs.
Time Frame
up to end of study
Title
Assessment of ECG parameters.
Time Frame
up to end of study
Secondary Outcome Measure Information:
Title
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time Frame
up to end of study
Title
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Time Frame
up to end of study
Title
Explore the PK/pharmacodynamic relationships for BIIB014.
Time Frame
up to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen Idec, MD
Organizational Affiliation
Cambridge, MA USA
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Petach Tikva
Country
Israel
Facility Name
Research Site
City
Ramat-Gan
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Sites
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Belgrade
Country
Serbia

12. IPD Sharing Statement

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

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