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NCT06568237PHASE2Recruiting

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

Teva Branded Pharmaceutical Products R&D LLC

Start Date

10/2/2024

Completion Date

9/15/2027

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.

Detailed Description

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

Eligibility Criteria

Age Range: 30 years to 75 years

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

Interventions

DRUG

TEV-56286

DRUG

Placebo

Interested in This Trial?

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Conditions

Multiple System Atrophy

Locations

Teva Investigational Site 15554

La Jolla, California 92037

United States

Teva Investigational Site 15545

Los Angeles, California 90095

United States

Teva Investigational Site 15547

Washington D.C., District of Columbia 20007

United States

Teva Investigational Site 15544

Boca Raton, Florida 33486

United States

Teva Investigational Site 15555

Tampa, Florida 33613

United States

Teva Investigational Site 15550

Chicago, Illinois 60612-3852

United States

Teva Investigational Site 15546

Kansas City, Kansas 66160

United States

Teva Investigational Site 15736

Boston, Massachusetts 02115

United States

Teva Investigational Site 15870

Farmington Hills, Michigan 48334

United States

Teva Investigational Site 15552

Rochester, Minnesota 55905

United States

Teva Investigational Site 15549

New York, New York 10016

United States

Teva Investigational Site 15551

New York, New York 10032-3726

United States

Teva Investigational Site 15553

Durham, North Carolina 27705-4410

United States

Teva Investigational Site 15735

Hershey, Pennsylvania 17033

United States

Teva Investigational Site 15548

Pittsburgh, Pennsylvania 15213

United States

Teva Investigational Site 15874

Nashville, Tennessee 37212

United States

Teva Investigational Site 15869

Georgetown, Texas 78628

United States

Teva Investigational Site 15873

Alexandria, Virginia 22310

United States

Teva Investigational Site 15543

Spokane, Washington 99202

United States

Teva Investigational Site 35290

Bordeaux, 33400

France

Teva Investigational Site 35300

Caen, 14033

France

Teva Investigational Site 35289

Marseille, 13385

France

Teva Investigational Site 35291

Paris, 75651 Cedex 13

France

Teva Investigational Site 35292

Toulouse, 31059

France

Teva Investigational Site 32823

Beelitz, 14547

Germany

Teva Investigational Site 32818

Dresden, 01307

Germany

Teva Investigational Site 32822

Düsseldorf, 40225

Germany

Teva Investigational Site 32825

Kassel, 34128

Germany

Teva Investigational Site 32826

Leipzig, 04103

Germany

Teva Investigational Site 32824

Marburg, 35033

Germany

Teva Investigational Site 32820

München, 81377

Germany

Teva Investigational Site 32819

Münster, 48149

Germany

Teva Investigational Site 32821

Ulm, 89081

Germany

Teva Investigational Site 80203

Haifa, 31999

Israel

Teva Investigational Site 80215

Jerusalem, 9103102

Israel

Teva Investigational Site 80204

Tel Aviv, 6423906

Israel

Teva Investigational Site 30299

Bologna, 40139

Italy

Teva Investigational Site 30297

Catania, 95123

Italy

Teva Investigational Site 30298

Milan, 20132

Italy

Teva Investigational Site 30294

Padova, 35127

Italy

Teva Investigational Site 30296

Roma, 00163

Italy

Teva Investigational Site 30295

Salerno, 84131

Italy

Teva Investigational Site 84140

Chiba, 260-8677

Japan

Teva Investigational Site 84139

Fuchū, 183-0042

Japan

Teva Investigational Site 84136

Gifu, 501-1112

Japan

Teva Investigational Site 84137

Niigata, 951-8520

Japan

Teva Investigational Site 84138

Sagamihara, 252-0392

Japan

Teva Investigational Site 84141

Sanda-shi, 669-1592

Japan

Teva Investigational Site 84135

Sendai, 982-8555

Japan

Teva Investigational Site 61808

Belgrade, 11000

Serbia

Teva Investigational Site 31328

Barakaldo, 48903

Spain

Teva Investigational Site 31323

Barcelona, 08035

Spain

Teva Investigational Site 31321

Barcelona, 08036

Spain

Teva Investigational Site 31324

Barcelona, 08041

Spain

Teva Investigational Site 31329

Elche, 03203

Spain

Teva Investigational Site 31327

Madrid, 28006

Spain

Teva Investigational Site 31330

Madrid, 28034

Spain

Teva Investigational Site 31331

Madrid, 28041

Spain

Teva Investigational Site 31320

Pamplona, 31008

Spain

Teva Investigational Site 31322

Seville, 41015

Spain

Teva Investigational Site 31319

Valencia, 46026

Spain