VX15/2503 Treatment for Huntington's Disease

Description

The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy of VX15/2503 in subjects with late prodromal and early manifest Huntington disease.

Study Start Date

July 2015

Estimated Completion Date

August 2018

Interventions

  • Drug: VX15/2503
  • Drug: Placebo

Specialties

  • Internal Medicine: Clinical Pharmacology,Neurology
  • Neurology: Basic Science/Genetics,Dementia,Demyelinating Disorders,Movement Disorders,Neuro/Psych pharmacology
  • Pharmacy: Neuro/Psych pharmacology,Pharmacokinetics

MeSH Terms

  • Basal Ganglia Diseases
  • Brain Diseases
  • Central Nervous System Diseases
  • Huntington Disease

Study ID

Vaccinex Inc. -- VX15/2503-N-131

Status

Unknown

Trial ID

NCT02481674

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

84

Sponsor

Vaccinex Inc.

Inclusion Criteria Highlights: 1. Male or female and are at least greater than or equal to 21 years of age at Screening. 2. Must fulfill one of the following criteria at Screening: 1. Late prodromal HD as defined by a CAP score of greater than 200 and DCL 2 or 3, 2. Early manifest HD as defined by a TFC greater than or equal to 11. Subject must have been given a clinical diagnosis of HD. 3. Must fulfill both of the following criteria at Screening: 1. Have undergone genetic testing with a known CAG repeat greater than or equal to 36, 2. No features of juvenile HD (Westphal variant). 4. If female must be either surgically sterile, postmenopausal, or nonlactating and nonpregnant. Female subjects of childbearing potential must practice a highly effective method of contraception. 5. If male must agree to use a reliable method of birth control. 6. Are willing and capable of providing informed consent for study participation and CAG genotyping (all subjects). 7. Are capable of reading, writing, and communicating effectively with others. 8. Are taking stable doses of any concomitant medications (including tetrabenazine) during the 1 month prior to the Baseline Visit and dosing must remain stable during the duration of the study. Exclusion Criteria Highlights: 1. Have participated in an investigational drug or device study within 30 days of the Baseline Visit, or 180 days if previous investigational drug was a MAb therapeutic. 2. Have had previous neurosurgery for Huntington disease or other movement disorders. 3. Are a suicide risk. 4. Have marked cognitive impairment with a Montreal Cognitive Assessment (MoCA) Score less than or equal to 22. 5. Have a presence of clinically significant psychosis and/or confusional states 6. Have clinically significant laboratory or ECG abnormalities at Screening 7. Have clinically relevant hematologic, hepatic, cardiac, or renal disease. 8. Have a medical history of infection with human immunodeficiency virus, hepatitis C, and/or hepatitis B. 9. Have a history of substance abuse (based on DSMIV criteria) within the past 12 months prior to Screening. 10. If female are pregnant or breastfeeding. 11. Have a known allergy to any ingredient in the study drug. 12. Have a history of malignancy of any type within 2 years prior to Screening. A history of surgically excised non-melanoma skin cancers, and superficial bladder or prostate cancer is permitted. 13. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality which in the judgment of the investigator makes the subject unsuitable for the study. 14. Have any significant findings not related to HD on the screening MRI which in the judgment of the investigator makes the subject unsuitable for the study. 15. Have any of the following conditions (which would exclude MRI participation): 1. An implant/device/condition that is contraindicated for MRI 2. Weight above 158 kg 16. Are undergoing FDG-PET and have any of the following conditions: 1. Are unable to fast for 6 or more hours prior to the scan 2. Have received research-related radiation exposure that exceeds institutional guidelines (e.g., 50 mSv in the prior year), if applicable

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Charlestown, Massachusetts 2.9 miles Diana Rosas MD MS None None
Columbia University - New York, New York 181.2 miles Karen Marder MD PhD None None
University of Vermont - Burlington, Vermont 181.7 miles James Boyd MD None None
University of Rochester - Rochester, New York 332.3 miles Richard Barbano MD PhD None None
Georgetown University - Washington, District of Columbia 394.4 miles Karen Anderson MD None None
Duke University Health Center - Durham, North Carolina 608.4 miles Burton Scott MD PhD None None
Ohio State University - Columbus, Ohio 641.8 miles Sandra Kostyk MD PhD None None
University of Michigan - Ann Arbor, Michigan 644.6 miles Praveen Dayalu MD None None
University of Toledo - Toledo, Ohio 646.5 miles Lawrence Elmer MD PhD None None
Wake Forest University - Winston Salem, North Carolina 659.2 miles Francis Walker MD None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles Andrew Duker MD None None
University of Louisville - Louisville, Kentucky 823.2 miles Kathrin LaFaver MD None None
Emory University School of Medicine - Atlanta, Georgia 930.3 miles Stewart A Factor DO None None
Vanderbilt University - Nashville, Tennessee 944.2 miles Daniel Claassen MD None None
Washington University - St Louis, Missouri 1,039.5 miles Brad Racette MD None None
University of Iowa - Iowa City, Iowa 1,050.4 miles John Kamholz MD None None
University of Alabama at Birmingham - Birmingham, Alabama 1,051.7 miles Victor Sung MD PhD None None
University of Colorado Denver - Aurora, Colorado 1,759.8 miles Lauren Seeberger MD None None
University of California San Diego - La Jolla, California 2,583.7 miles Jody CoreyBloom MD PhD None None

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