A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
Purpose
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Condition
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Between 30 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria - is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination - Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits - Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods - Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods - Additional criteria apply; please contact the investigator for more information
Exclusion Criteria
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA - has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening - has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening - is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study - has a known hypersensitivity to any components of the IMP - is of a vulnerable population (eg, people kept in detention or jail) - participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study - Additional criteria apply; please contact the investigator for more information
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TEV-56286 |
Orally administered capsules once daily |
|
|
Placebo Comparator Placebo |
Orally administered capsules once daily |
|
Recruiting Locations
Teva Investigational Site 15554
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
Teva Investigational Site 15545
Los Angeles 5368361, California 5332921 90095
Los Angeles 5368361, California 5332921 90095
Teva Investigational Site 15547
Washington D.C. 4140963, District of Columbia 4138106 20007
Washington D.C. 4140963, District of Columbia 4138106 20007
Teva Investigational Site 15544
Boca Raton 4148411, Florida 4155751 33486
Boca Raton 4148411, Florida 4155751 33486
Teva Investigational Site 15555
Tampa 4174757, Florida 4155751 33063
Tampa 4174757, Florida 4155751 33063
Teva Investigational Site 15550
Chicago 4887398, Illinois 4896861 60612-3852
Chicago 4887398, Illinois 4896861 60612-3852
Teva Investigational Site 15546
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Teva Investigational Site 15736
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Teva Investigational Site 15870
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48334
Teva Investigational Site 15552
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Teva Investigational Site 15549
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
Teva Investigational Site 15551
New York 5128581, New York 5128638 10032-3726
New York 5128581, New York 5128638 10032-3726
Teva Investigational Site 15553
Durham 4464368, North Carolina 4482348 27705-4410
Durham 4464368, North Carolina 4482348 27705-4410
Teva Investigational Site 15735
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Teva Investigational Site 15548
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Teva Investigational Site 15869
Georgetown 4693342, Texas 4736286 78628
Georgetown 4693342, Texas 4736286 78628
Teva Investigational Site 15873
Alexandria 4744091, Virginia 6254928 22310
Alexandria 4744091, Virginia 6254928 22310
Teva Investigational Site 15543
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
More Details
- NCT ID
- NCT06568237
- Status
- Recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Detailed Description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan