Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438607
• Other study ID #: 204PD202
• Secondary ID: EUDRA CT NO: 200
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2007
• Last updated: July 10, 2009
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: Ministry of HealthIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
• Placebo
Matched placebo for MTD or MTD-1

Locations

Country	Name	City	State
India	Research Sites	Bangalore
India	Research Site	Chennai
India	Research Site	Hyderabaad
India	Research Site	Ludhiana
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Secunderabad
Israel	Research Site	Ashkelon
Israel	Research Site	Jerusalem
Israel	Research Site	Ramat-Gan
Israel	Research Site	Tel Aviv
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

India,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and proportion of subjects with adverse events		up to end of study	Yes
Primary	Assessment of clinical laboratory parameters		up to end of study	Yes
Primary	Assessment of vital signs		up to end of study	Yes
Primary	Assessment of ECG parameters.		up to end of study	Yes
Secondary	Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.		up to 24h following last dose (Part A only)	No
Secondary	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)	No