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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00442780
• Date of registration: 01/03/2007
• Primary sponsor: Biogen Idec
• Public title: Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease MOBILE
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease
• Date of first enrolment: August 2007
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00442780
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Former Serbia and Montenegro, Israel, Poland, Serbia

Contacts

• Name: Biogen Idec, MD
• Affiliation: Cambridge, MA USA

Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: BIIB014

Drug: Placebo

Primary Outcome(s)

Assessment of clinical laboratory parameters. [Time Frame: up to end of study]

Assessment of ECG parameters. [Time Frame: up to end of study]

Assessment of vital signs. [Time Frame: up to end of study]

Number and proportion of subjects with adverse events [Time Frame: up to end of study]

Secondary Outcome(s)

Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma. [Time Frame: up to end of study]

Explore BIIB014 activity by evaluating standard Parkinson's disease assessments. [Time Frame: up to end of study]

Explore the PK/pharmacodynamic relationships for BIIB014. [Time Frame: up to end of study]

Secondary ID(s)

204PD203

EUDRA CT NO: 2007-000398-47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors