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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00442780 |
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:
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.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: BIIB014 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 36 |
Study Start Date: | August 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Dose Level A of BIIB014
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Drug: BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Drug: Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
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2: Placebo Comparator
Dose Level B of BIIB014
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Drug: BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Drug: Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
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3: Placebo Comparator
Dose Level C of BIIB014
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Drug: BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Drug: Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
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4: Placebo Comparator
Dose Level D of BIIB014
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Drug: BIIB014
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Drug: Placebo
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Research Site | |
Tel Aviv, Israel | |
Research Site | |
Petach Tikva, Israel | |
Research Site | |
Ramat-Gan, Israel | |
Research Site | |
Ashkelon, Israel | |
Poland | |
Research Site | |
Krakow, Poland | |
Research Site | |
Warszawa, Poland | |
Research Site | |
Kielce, Poland | |
Research Site | |
Poznan, Poland | |
Serbia | |
Research Sites | |
Belgrade, Serbia | |
Research Site | |
Belgrade, Serbia |
Study Director: | Biogen Idec, MD | Cambridge, MA USA |
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 204PD203, EUDRA CT NO: 2007-000398-47 |
Study First Received: | March 1, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00442780 |
Health Authority: | Israel: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
early Parkinson's Disease MOBILE BIIB014 |
Signs and Symptoms Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Nervous System Diseases |