NCT00438607

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

  • 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

February 20, 2007

Last Update Submit

July 10, 2009

Conditions

Parkinson's Disease

Keywords

Moderate to late stage Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

  • Number and proportion of subjects with adverse events

    up to end of study

  • Assessment of clinical laboratory parameters

    up to end of study

  • Assessment of vital signs

    up to end of study

  • Assessment of ECG parameters.

    up to end of study

Secondary Outcomes (2)

  • Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.

    up to 24h following last dose (Part A only)

  • Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments

    up to 8h following last dose (Part A); up to 24h following last dose (Part B only)

Study Arms (3)

1

OTHER

BIIB014 at MTD from Part A

Drug: BIIB014

2

OTHER

BIIB014 at dose immediately below MTD from Part A

Drug: BIIB014

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BIIB014DRUG

oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks

12
PlaceboDRUG

Matched placebo for MTD or MTD-1

3

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Sites

Bangalore, India

Location

Research Site

Chennai, India

Location

Research Site

Hyderabaad, India

Location

Research Site

Ludhiana, India

Location

Research Site

Mumbai, India

Location

Research Site

New Delhi, India

Location

Research Site

Secunderabad, India

Location

Research Site

Ashkelon, Israel

Location

Research Site

Jerusalem, Israel

Location

Research Site

Ramat Gan, Israel

Location

Research Site

Tel Aviv, Israel

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Norwich, United Kingdom

Location

Research Site

Salford, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Biogen Idec

    Cambridge, MA USA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

IN(7)IL(4)GB(4)