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

January 8, 2009 updated by: Biogen

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Dose Level A of BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
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
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
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
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
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
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of subjects with adverse events
Time Frame: up to end of study
up to end of study
Assessment of clinical laboratory parameters.
Time Frame: up to end of study
up to end of study
Assessment of vital signs.
Time Frame: up to end of study
up to end of study
Assessment of ECG parameters.
Time Frame: up to end of study
up to end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time Frame: up to end of study
up to end of study
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Time Frame: up to end of study
up to end of study
Explore the PK/pharmacodynamic relationships for BIIB014.
Time Frame: up to end of study
up to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Biogen Idec, MD, Cambridge, MA USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (Estimate)

March 2, 2007

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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