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

Parkinson's Disease Clinical Trial

— MOBILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442780
• Other study ID #: 204PD203
• Secondary ID: EUDRA CT NO: 200
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2007
• Last updated: January 8, 2009
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 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 per dose, schedule,and duration specified in protocol
• Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014

Locations

Country	Name	City	State
Israel	Research Site	Ashkelon
Israel	Research Site	Petach Tikva
Israel	Research Site	Ramat-Gan
Israel	Research Site	Tel Aviv
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Serbia	Research Site	Belgrade
Serbia	Research Sites	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Israel,  Poland,  Serbia, 

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 end of study	No
Secondary	Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.		up to end of study	No
Secondary	Explore the PK/pharmacodynamic relationships for BIIB014.		up to end of study	No