Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:7/27/2017
Start Date:July 2015
End Date:August 2016

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A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the
specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with
progressive supranuclear palsy (PSP).

This study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose
(within dosing range) of intravenous (IV) infusion of C2N-8E12 in 32 patients with
progressive supranuclear palsy (PSP). Four sequential cohorts will receive increasing single
doses of either C2N-8E12 or placebo. Out of every 4 patients enrolled 3 patients will receive
drug and 1 will receive placebo. Study participants will be followed for a minimum of 2
months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and
immunogenicity of C2N-8E12.

Key Inclusion Criteria:

- Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231
clinical trials

- Brain MRI at Screening is consistent with PSP;

- Stable medications for Parkinsonism for at least 2 months prior to Screening;

- Agree to use protocol specified methods of contraception.

Key Exclusion Criteria:

- Signs of a progressive neurological disorder that better meets the criteria for types
of neurological disorders other than PSP;

- Currently on any other biologic or immunomodulatory therapy;

- Subjects that reside at a skilled nursing or dementia care facility;

- Diagnosis of any other significant unrelated neurological or psychiatric disorders
that could account for cognitive deficits;

- Untreated major depression at baseline evaluation, based on clinical judgment and
results in geriatric depression scale;

- Unable to tolerate MRI scan at Screening or any other contraindication to MRI;

- Any contraindication to or unable to tolerate lumbar puncture at Screening, including
use of anti-coagulant medications.
We found this trial at
12
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Daniel O. Claassen, MD
Phone: 615-875-1182
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Zbigniew K. Wszolek, MD
Phone: 904-953-2000
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Lawrence S. Honig, MD, PhD
Phone: 212-305-2371
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Birmingham, Alabama 35294
Principal Investigator: Erik Roberson, MD, PhD
Phone: 205-996-3659
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Birmingham, AL
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Dallas, Texas 75231
Principal Investigator: Diana Kerwin, MD
Phone: 214-345-4449
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3450 Hull Road
Gainesville, Florida 32610
Principal Investigator: Nikolaus McFarland, MD, PhD
Phone: 352-273-9528
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Gainesville, FL
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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Indianapolis, IN
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Los Angeles, California 90095
Principal Investigator: Yvette Bordelon, MD, PhD
Phone: 310-206-3356
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Los Angeles, CA
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Rochester, Minnesota 55905
Principal Investigator: Bradley F. Boeve, MD
Phone: 507-284-1324
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Rochester, MN
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San Diego, California 92037
Principal Investigator: Irene Litvan, MD
Phone: 858-822-5786
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San Francisco, California 94143
Principal Investigator: Adam Boxer, MD, PhD
Phone: 415-476-0661
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Scottsdale, Arizona 85259
Principal Investigator: Erika Driver-Dunkley, MD
Phone: 480-342-1316
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