Study of BIIB092 in Participants With Progressive Supranuclear Palsy

Phase 1

• Conditions: Progressive supranuclear palsy; MedDRA version: 21.1Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002554-21-AT
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-20
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

• Participants with probable or possible Progressive Supranuclear Palsy (PSP)
• Able to ambulate independently or with assistance
• Able to tolerate Magnetic Resonance Imaging (MRI)
• Have reliable caregiver to accompany participant to all study visits
• Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening
• Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 321

Exclusion Criteria

• Presence of other significant neurological or psychiatric disorders
• Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neauron disease
• History of early, prominent rapid eye movement (REM) sleep behaviour disorder
• History of or screening brain MRI scan indicative of significant abnormality
• Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified