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NCT07197866PHASE2Recruiting

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

Teva Branded Pharmaceutical Products R&D LLC

Start Date

9/30/2025

Completion Date

5/17/2029

Summary

The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286. The planned total duration of the trial is approximately 100 weeks.

Eligibility Criteria

Age Range: 30 years to No maximum

Inclusion Criteria: * Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements * Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit * Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP * Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product NOTE - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial * Is of a vulnerable population (eg, people kept in detention or jail) * Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial Note - Additional criteria apply, please contact the investigator for more information

Interventions

DRUG

TEV-56286

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 15544

Boca Raton, Florida 33486

United States

Teva Investigational Site 15555

Tampa, Florida 33613

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 15543

Spokane, Washington 99202

United States

Teva Investigational Site 35290

Bordeaux, 33400

France

Teva Investigational Site 35291

Paris, 75651

France

Teva Investigational Site 35292

Toulouse, 31059

France

Teva Investigational Site 32818

Dresden, 01307

Germany

Teva Investigational Site 32822

Düsseldorf, 40225

Germany

Teva Investigational Site 32825

Kassel, 34128

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 80203

Haifa, 31999

Israel

Teva Investigational Site 80204

Tel Aviv, 6423906

Israel

Teva Investigational Site 30299

Bologna, 40139

Italy

Teva Investigational Site 30298

Milan, 20132

Italy

Teva Investigational Site 30296

Roma, 00163

Italy

Teva Investigational Site 30295

Salerno, 84131

Italy

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 31324

Barcelona, 08025

Spain

Teva Investigational Site 31323

Barcelona, 08035

Spain

Teva Investigational Site 31320

Pamplona, 31008

Spain

Teva Investigational Site 31322

Seville, 41013

Spain

Teva Investigational Site 31319

Valencia, 46026

Spain