Trial record 6 of 26 for:    neurology AND university of california, san francisco | Open Studies

Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy (CN002-003)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02460094
First received: May 20, 2015
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intravenous infusions of BMS-986168 and to assess the pharmacodynamics of BMS-986168 on cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with Progressive Supranuclear Palsy.

Condition Intervention Phase
Progressive Supranuclear Palsy
Drug: BMS-986168
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and tolerability. [ Time Frame: Day 1 - Day 169 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of BMS-986168 in serum. [ Time Frame: Day 1 - Day 169 ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) effects of BMS-986168 on extracellular tau (eTau) in cerebrospinal fluid. [ Time Frame: Day 1 - Day 169 ] [ Designated as safety issue: No ]
  • Immunogenicity of BMS-986168 measured by presence or absence of anti-BMS-986168 antibodies in serum. [ Time Frame: Day 1 - Day 169 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: September 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel 1: BMS-986168/ Placebo
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BMS-986168 Drug: Placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
Experimental: Panel 2: BMS-986168/ Placebo
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BMS-986168 Drug: Placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
Experimental: Panel 3: BMS-986168/ Placebo
BMS-986168 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Drug: BMS-986168 Drug: Placebo
(0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)

  Eligibility

Ages Eligible for Study:   41 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Probable or possible PSP defined as:

    • at least a 12-month history of postural instability or falls during the first 3 years that symptoms are present
    • a decreased downward saccade velocity at screening defined as observable eye movement deviation from the "main sequence" linear relationship between saccade amplitude and saccade velocity; or supranuclear ophthalmoplegia defined as 50% reduction in upward gaze or 30% reduction in downward gaze; and
    • age at symptom onset of 40 to 85 years by history and current age between 41 and 86 years, inclusive, at the time of screening; and
    • an akinetic-rigid syndrome with prominent axial rigidity.
    • presence of symptoms for less than 5 years.
  2. Body weight range of ≥ 43 kg/95 lbs to ≤ 118 kg/260 lbs.
  3. Able to tolerate MRI.
  4. Able to perform all protocol-specified assessments and comply with the study visit schedule.
  5. Have reliable caregiver to accompany patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
  6. Score ≥ 20 on the Mini Mental State Exam (MMSE) at screening.
  7. Patient must reside outside a skilled nursing facility or dementia care facility at the time of screening, and admission to such a facility is not planned. Residence in an assisted living facility is allowed.
  8. Ability to ambulate independently or with assistance defined as the ability to take at least 5 steps with a walker (guarding is allowed provided there is no contact) or the ability to take at least 5 steps without a walker or cane with the assistance of another person who can only have contact with one upper extremity.
  9. Stable on other chronic medications for at least 30 days prior to screening.
  10. Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control.

Exclusion Criteria

  1. Presence of other significant neurological or psychiatric disorders.
  2. History of or screening brain MRI scan indicative of significant abnormality.
  3. History of cancer within 5 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
  4. History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease.
  5. Inability to be venipunctured and/or tolerate venous access.
  6. Contraindication to undergoing an LP.
  7. Recent drug or alcohol abuse as defined in DSM IV.
  8. Treatment with any investigational drugs (including placebo) or devices within 90 days prior to screening.
  9. Contraindication to the MRI examination for any reason
  10. History of a clinically significant medical condition that would interfere with the patient's ability to comply with study instructions, would place the patient at increased risk, or might confound the interpretation of the study results.
  11. History of allergy, hypersensitivity, or serious adverse reaction to monoclonal antibodies or related compounds or allergy to any of the components of the study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02460094

Contacts
Contact: Please contact recruiting sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States
Contact: Linda Cowden, Site 0006    205-975-2779    lcowden@uabmc.edu   
Principal Investigator: David Geldmacher         
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States
Contact: Diane Yang, Site 0007    310-206-2154    ddyang@mednet.ucla.edu   
Principal Investigator: Yvette Bordelon         
University of California San Diego Recruiting
San Diego, California, United States
Contact: Rachel Sinit, Site 0001    858-822-5786    rssinit@ucsd.edu   
Principal Investigator: Irene Litvan         
University of California, San Francisco, Medical Center at Parnassus Recruiting
San Francisco, California, United States
Contact: Mary Koestler, Site 0010    415-476-0668    mkoestler@memory.ucsf.edu   
Principal Investigator: Adam Boxer         
United States, Florida
Parkinsons Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States
Contact: Jocelyne Fimiano, Site 0013    561-392-1818 ext 6    jfimiano@parkinsonscenter.org   
Principal Investigator: Stuart Isaacson         
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States
Contact: Erin Hastings Monari, Site 0009    352-294-5030    Erin.Hastings@neurology.ufl.edu   
Principal Investigator: Nikolaus McFarland         
University of South Florida Recruiting
Tampa, Florida, United States
Contact: Jessica Shaw, Site 0012    813-974-5909    jshaw@health.usf.edu   
Principal Investigator: Theresa Zesiewicz         
United States, Illinois
The University of Chicago Department of Neurology Recruiting
Chicago, Illinois, United States
Contact: Tao Xie, Site 0015    773-702-3038    txie@neurology.bsd.uchicago.edu   
Principal Investigator: Tao Xie         
United States, Maryland
Parkinson's & Movement Disorders Center of Maryland Recruiting
Elkridge, Maryland, United States
Contact: Erica Stacy, Site 0002    443-755-0030    estacy@pdmdcenter.com   
Principal Investigator: Joseph Savitt         
United States, Minnesota
University of Minnesota Medical School Recruiting
Minneapolis, Minnesota, United States
Contact: Jennifer Sees, Site 0005    612-624-5978    seesx001@umn.edu   
Principal Investigator: Paul Tuite         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States
Contact: Deborah Caputo, Site 0004    732-235-7729    caputodl@rwjms.rutgers.edu   
Principal Investigator: Lawrence Golbe         
United States, New York
Columbia University Medical Center Recruiting
New York City, New York, United States
Contact: Evelyn Dominguez, Site 0008    212-305-2371    edd5@cumc.columbia.edu   
Principal Investigator: Lawrence Honig         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Courtney Igne, Site 0011    215-662-3596    cigne@mail.med.upenn.edu   
Principal Investigator: Murray Grossman         
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States
Contact: Jennifer Armstrong, Site 0003    214-648-3470    Jennifer.Armstrong@utsouthwestern.edu   
Principal Investigator: Padraig O'Suilleabhain         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Adam Boxer UCSF Memory and Aging Center
  More Information

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02460094     History of Changes
Other Study ID Numbers: CN002-003 
Study First Received: May 20, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Ocular Motility Disorders
Ophthalmoplegia
Paralysis
Signs and Symptoms
Tauopathies

ClinicalTrials.gov processed this record on May 26, 2016