Phase
Condition
Spinal Cord Injuries
Treatment
EG110A
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
Participant has stable supra-sacral traumatic SCI with American Spinal InjuryAssociation (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12months before Screening.
Participant has UI due to urodynamically-confirmed NDO for at least 3 months priorto Screening.
Participant has:
been treated for NDO for at least 3 months prior to Screening with an adequatecourse of oral pharmacotherapy(ies) and/or has had intolerable side-effectsand/or exhibited an inadequate response in the opinion of the investigator andparticipant, i.e., at least 8 UI episodes in a week despite consistent use ofthe therapy. Participant does not wish to proceed to BoNT/A treatment, andtheir next step would be surgical intervention.OR
had an inadequate response to BoNT/A treatment in the opinion of theinvestigator and participant, i.e., at least 8 UI episodes in a week, and thelast BoNT/A treatment for their NDO was at least 6 months prior to screening.Treatment with BoNT/A was not started more than 7 years ago, and their nextstep would be surgical intervention.
Exclusion
Main Exclusion Criteria:
Participant has previous or current tumor or malignancy affecting the spinal columnor spinal cord, or any other nonstable cause of SCI.
Participant with active oral or genital herpes lesion. If the participant has anactive oral or genital herpes infection this needs to be treated and healed first.The participant may be rescreened once the lesion has fully healed (at least 4 weeksafter the lesion has healed).
Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and hastoxicities/AEs attributable to previously administered cancer therapies that havenot resolved or stabilized.
Study Design
Study Description
Connect with a study center
Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
United StatesActive - Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Sidney Kimmel Medical College
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
TIRR Memorial Hermann
Houston, Texas 77030
United StatesSite Not Available
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas 77030
United StatesActive - Recruiting
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