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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

March 1, 2007
January 8, 2009
August 2007
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Number and proportion of subjects with adverse events.
  • Assessment of clinical laboratory parameters.
  • Assessment of vital signs.
  • Assessment of ECG parameters.
Complete list of historical versions of study NCT00442780 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Estimate PK parameters of BIIB014 and its N-acetyl metabolite.
  • Explore the activity of BIIB014.
  • Explore the PK/pharmacodynamic relationships for BIIB014.
Not Provided
Not Provided
 
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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: 1
    Dose Level A of BIIB014
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
  • Placebo Comparator: 2
    Dose Level B of BIIB014
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
  • Placebo Comparator: 3
    Dose Level C of BIIB014
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
  • Placebo Comparator: 4
    Dose Level D of BIIB014
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Poland,   Serbia
 
NCT00442780
204PD203, EUDRA CT NO: 2007-000398-47
Yes
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Study Director: Biogen Idec, MD Cambridge, MA USA
Biogen Idec
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP