Actively Recruiting
A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for Treatment of Multiple System Atrophy
Led by Teva Branded Pharmaceutical Products R&D LLC · Updated on 2026-06-04
350
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of TEV-56286, an oral medication, for treating adults with Multiple System Atrophy (MSA). This phase 2 study aims to assess how well TEV-56286 works, measure specific treatment responses, and monitor its safety and tolerability. The trial is sponsored by Teva Branded Pharmaceutical Products R&D LLC and will take place across several countries including the US, Israel, and Japan. Participants will take TEV-56286 or a placebo once daily as capsules during a 48-week double-blind treatment period. Before this, there is a screening period of up to 4 weeks to determine eligibility. After completing the treatment, participants will attend a follow-up visit about 4 weeks later. The total time per participant is approximately 56 weeks, with the overall study lasting around 27 months. During the study, researchers will assess participant health using measures like the Unified Multiple System Atrophy Rating Scale (UMSARS), MRI scans to measure brain volumes, walking tests, and quality of life questionnaires. Safety will be monitored through adverse event tracking, laboratory tests, and vital signs. The primary outcome focuses on changes in MSA symptoms from baseline to week 48, with additional measures evaluating physical function and disease progression.
CONDITIONS
Brief Title
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with clinically possible or probable Multiple System Atrophy using Gilman criteria
- Medically and psychiatrically stable based on history and examinations
- Females of childbearing potential must have a negative pregnancy test at screening and baseline
- Females of childbearing potential with fertile male partners must use highly effective birth control
- Males capable of fathering children and their female partners of childbearing potential must use highly effective birth control
You will not qualify if you...
- Having two or more relatives with history of Multiple System Atrophy suggesting another diagnosis
- Participation in another clinical study involving investigational medicinal products within 3 months or 5 half-lives before screening
- History or acknowledgement of alcohol or substance abuse within 12 months before screening
- Pregnant or breastfeeding females or those planning pregnancy during the study
- Known allergy to any investigational medicinal product components
- Being part of a vulnerable population such as detainees or jailed individuals
- Use of prohibited medications during specified exclusion periods in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive oral capsules of TEV-56286 or placebo once daily as part of the study treatment.
Regular visits during treatment as scheduled by the study (visit frequency not specified)
Trial Site Locations
Total: 55 locations
1
Teva Investigational Site 15554
La Jolla, California, United States, 92037
Active, Not Recruiting
2
Teva Investigational Site 15545
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
Teva Investigational Site 15547
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
4
Teva Investigational Site 15544
Boca Raton, Florida, United States, 33486
Active, Not Recruiting
5
Teva Investigational Site 15555
Tampa, Florida, United States, 33613
Active, Not Recruiting
6
Teva Investigational Site 15550
Chicago, Illinois, United States, 60612-3852
Active, Not Recruiting
7
Teva Investigational Site 15546
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
8
Teva Investigational Site 15736
Boston, Massachusetts, United States, 02115
Active, Not Recruiting
9
Teva Investigational Site 15870
Farmington Hills, Michigan, United States, 48334
Not Yet Recruiting
10
Teva Investigational Site 15552
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
11
Teva Investigational Site 15549
New York, New York, United States, 10016
Active, Not Recruiting
12
Teva Investigational Site 15551
New York, New York, United States, 10032-3726
Active, Not Recruiting
13
Teva Investigational Site 15553
Durham, North Carolina, United States, 27705-4410
Active, Not Recruiting
14
Teva Investigational Site 15735
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
15
Teva Investigational Site 15548
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
16
Teva Investigational Site 15869
Georgetown, Texas, United States, 78628
Not Yet Recruiting
17
Teva Investigational Site 15873
Alexandria, Virginia, United States, 22310
Active, Not Recruiting
18
Teva Investigational Site 15543
Spokane, Washington, United States, 99202
Active, Not Recruiting
19
Teva Investigational Site 35290
Bordeaux, France, 33400
Active, Not Recruiting
20
Teva Investigational Site 35289
Marseille, France, 13385
Active, Not Recruiting
21
Teva Investigational Site 35291
Salpêtrière, France, 75651 Paris Ced
Active, Not Recruiting
22
Teva Investigational Site 35292
Toulouse, France, 31059
Active, Not Recruiting
23
Teva Investigational Site 32823
Beelitz-Heilstätten, Germany, 14547
Active, Not Recruiting
24
Teva Investigational Site 32818
Dresden, Germany, 01307
Active, Not Recruiting
25
Teva Investigational Site 32822
Düsseldorf, Germany, 40225
Active, Not Recruiting
26
Teva Investigational Site 32825
Kassel, Germany, 34128
Active, Not Recruiting
27
Teva Investigational Site 32826
Leipzig, Germany, 04103
Actively Recruiting
28
Teva Investigational Site 32824
Marburg, Germany, 35033
Active, Not Recruiting
29
Teva Investigational Site 32820
München, Germany, 81377
Active, Not Recruiting
30
Teva Investigational Site 32819
Münster, Germany, 48149
Active, Not Recruiting
31
Teva Investigational Site 32821
Ulm, Germany, 89081
Active, Not Recruiting
32
Teva Investigational Site 80203
Haifa, Israel, 31999
Active, Not Recruiting
33
Teva Investigational Site 80215
Jerusalem, Israel, 9103102
Active, Not Recruiting
34
Teva Investigational Site 80204
Tel Aviv, Israel, 6423906
Active, Not Recruiting
35
Teva Investigational Site 30299
Bologna, Italy, 40139
Active, Not Recruiting
36
Teva Investigational Site 30297
Catania, Italy, 95123
Active, Not Recruiting
37
Teva Investigational Site 30298
Milan, Italy, 20132
Active, Not Recruiting
38
Teva Investigational Site 30294
Padova, Italy, 35127
Active, Not Recruiting
39
Teva Investigational Site 30296
Roma, Italy, 00163
Active, Not Recruiting
40
Teva Investigational Site 30295
Salerno, Italy, 84131
Active, Not Recruiting
41
Teva Investigational Site 84140
Chiba, Japan, 260-8677
Active, Not Recruiting
42
Teva Investigational Site 84139
Fuchū, Japan, 183-0042
Active, Not Recruiting
43
Teva Investigational Site 84136
Gifu, Japan, 501-1112
Active, Not Recruiting
44
Teva Investigational Site 84137
Niigata, Japan, 951-8520
Active, Not Recruiting
45
Teva Investigational Site 84138
Sagamihara, Japan, 252-0392
Active, Not Recruiting
46
Teva Investigational Site 84141
Sanda-shi, Japan, 669-1592
Active, Not Recruiting
47
Teva Investigational Site 84135
Sendai, Japan, 982-8555
Active, Not Recruiting
48
Teva Investigational Site 31323
Barcelona, Spain, 08035
Active, Not Recruiting
49
Teva Investigational Site 31321
Barcelona, Spain, 08036
Active, Not Recruiting
50
Teva Investigational Site 31324
Barcelona, Spain, 08041
Active, Not Recruiting
51
Teva Investigational Site 31327
Madrid, Spain, 28006
Active, Not Recruiting
52
Teva Investigational Site 31331
Madrid, Spain, 28041
Actively Recruiting
53
Teva Investigational Site 31320
Pamplona, Spain, 31008
Active, Not Recruiting
54
Teva Investigational Site 31322
Seville, Spain, 41015
Active, Not Recruiting
55
Teva Investigational Site 31319
Valencia, Spain, 46026
Active, Not Recruiting
Research Team
T
Teva U.S. Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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