A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study

Last updated: June 4, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple System Atrophy

Treatment

Placebo

TEV-56286

Clinical Study ID

NCT06568237
TV56286-NDG-20039
2023-505320-54-00
  • Ages > 30
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • is considered to be "clinically possible" or "clinically probable" MSA as determinedby the Gilman criteria

  • is able to ambulate at least 10 meters without the assistance of another person atscreening; the use of assistive device (eg, cane, not walker) is allowed

  • is medically and psychiatrically stable, as indicated by medical and psychiatrichistory, as well as physical and neurological examination

  • Females of child bearing potential (CBP) may be included only if they have anegative pregnancy test at the screening and baseline visits

  • Females of CBP whose male partners are potentially fertile (ie, no vasectomy) mustuse 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 mustuse, together with their female partners, highly effective birth control methods

  • Additional criteria apply; please contact the investigator for more information

Exclusion

Exclusion Criteria:

  • has 2 or more relatives with history of MSA, suggestive of an alternative diagnosisother 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 monthsbefore screening

  • is a female participant who is pregnant or breastfeeding, or plans to becomepregnant 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 thespecified exclusionary windows of this study

  • Additional criteria apply; please contact the investigator for more information

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 02, 2024
Estimated Completion Date:
June 17, 2027

Study Description

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Connect with a study center

  • Teva Investigational Site 35290

    Bordeaux, 33400
    France

    Active - Recruiting

  • Teva Investigational Site 35289

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • Teva Investigational Site 35291

    Salpetriere, 47-83
    France

    Active - Recruiting

  • Teva Investigational Site 35292

    Toulouse, 31059
    France

    Active - Recruiting

  • Teva Investigational Site 32818

    Dresden, 01307
    Germany

    Active - Recruiting

  • Teva Investigational Site 32822

    Dusseldorf, 40225
    Germany

    Active - Recruiting

  • Teva Investigational Site 32825

    Kassel, 34128
    Germany

    Active - Recruiting

  • Teva Investigational Site 32824

    Marburg, 35033
    Germany

    Active - Recruiting

  • Teva Investigational Site 32819

    Muenster, 48149
    Germany

    Active - Recruiting

  • Teva Investigational Site 32820

    Munchen, 81377
    Germany

    Active - Recruiting

  • Teva Investigational Site 80203

    Haifa, 31999
    Israel

    Active - Recruiting

  • Teva Investigational Site 80204

    Tel-Aviv, 6423906
    Israel

    Active - Recruiting

  • Teva Investigational Site 30299

    Bologna, 40139
    Italy

    Active - Recruiting

  • Teva Investigational Site 30298

    Milano, 20132
    Italy

    Active - Recruiting

  • Teva Investigational Site 30296

    Roma, 00163
    Italy

    Active - Recruiting

  • Teva Investigational Site 30295

    Salerno, 84131
    Italy

    Active - Recruiting

  • Teva Investigational Site 84138

    Sagamihara, 252-0392
    Japan

    Active - Recruiting

  • Teva Investigational Site 84141

    Sanda-shi, 669-1592
    Japan

    Site Not Available

  • Teva Investigational Site 84135

    Sendai, 982-8555
    Japan

    Site Not Available

  • Teva Investigational Site 31321

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Teva Investigational Site 31323

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Teva Investigational Site 31324

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Teva Investigational Site 31320

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Teva Investigational Site 31322

    Sevilla, 41015
    Spain

    Active - Recruiting

  • Teva Investigational Site 31319

    Valencia, 46026
    Spain

    Active - Recruiting

  • Teva Investigational Site 15554

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Teva Investigational Site 15547

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Teva Investigational Site 15544

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Teva Investigational Site 15555

    Tampa, Florida 33063
    United States

    Active - Recruiting

  • Teva Investigational Site 15550

    Chicago, Illinois 60612-3852
    United States

    Site Not Available

  • Teva Investigational Site 15546

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Teva Investigational Site 15736

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Teva Investigational Site 15552

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Teva Investigational Site 15549

    New York, New York 10016
    United States

    Active - Recruiting

  • Teva Investigational Site 15551

    New York, New York 10032-3726
    United States

    Active - Recruiting

  • Teva Investigational Site 15553

    Durham, North Carolina 27705-4410
    United States

    Active - Recruiting

  • Teva Investigational Site 15735

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Teva Investigational Site 15543

    Spokane, Washington 99202
    United States

    Active - Recruiting

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