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NCT Number: NCT00438607

Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage 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 moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).

This study will also explore:

1. the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and 2. the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).

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.

The study will be divided into 2 parts:

* 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Sites, Bangalore, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Major Exclusion Criteria:

  • 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%

Treatment and study plan

BIIB014

Drug

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

Placebo

Drug

Matched placebo for MTD or MTD-1

Primary outcomes

  1. Number and proportion of subjects with adverse events

    Time frame: up to end of study

  2. Assessment of clinical laboratory parameters

    Time frame: up to end of study

  3. Assessment of vital signs

    Time frame: up to end of study

  4. Assessment of ECG parameters.

    Time frame: up to end of study

Secondary outcomes

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

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

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

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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2007
Registry last updated
Jul 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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