Movement Disorders Clinical Trials

Find Movement Disorders Clinical Trials Near You

A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Teva Investigational Site 15554
ACTIVE_NOT_RECRUITING
La Jolla
Teva Investigational Site 15545
NOT_YET_RECRUITING
Los Angeles
Washington, D.c.
Teva Investigational Site 15547
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Teva Investigational Site 15544
ACTIVE_NOT_RECRUITING
Boca Raton
Teva Investigational Site 15555
ACTIVE_NOT_RECRUITING
Tampa
Illinois
Teva Investigational Site 15550
ACTIVE_NOT_RECRUITING
Chicago
Kansas
Teva Investigational Site 15546
ACTIVE_NOT_RECRUITING
Kansas City
Massachusetts
Teva Investigational Site 15736
ACTIVE_NOT_RECRUITING
Boston
Michigan
Teva Investigational Site 15870
NOT_YET_RECRUITING
Farmington Hills
Minnesota
Teva Investigational Site 15552
ACTIVE_NOT_RECRUITING
Rochester
North Carolina
Teva Investigational Site 15553
ACTIVE_NOT_RECRUITING
Durham
New York
Teva Investigational Site 15549
ACTIVE_NOT_RECRUITING
New York
Teva Investigational Site 15551
ACTIVE_NOT_RECRUITING
New York
Pennsylvania
Teva Investigational Site 15735
NOT_YET_RECRUITING
Hershey
Teva Investigational Site 15548
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Teva Investigational Site 15874
RECRUITING
Nashville
Texas
Teva Investigational Site 15869
NOT_YET_RECRUITING
Georgetown
Virginia
Teva Investigational Site 15873
ACTIVE_NOT_RECRUITING
Alexandria
Washington
Teva Investigational Site 15543
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
France
Teva Investigational Site 35290
ACTIVE_NOT_RECRUITING
Bordeaux
Teva Investigational Site 35300
RECRUITING
Caen
Teva Investigational Site 35289
ACTIVE_NOT_RECRUITING
Marseille
Teva Investigational Site 35291
ACTIVE_NOT_RECRUITING
Paris
Teva Investigational Site 35292
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Teva Investigational Site 32823
ACTIVE_NOT_RECRUITING
Beelitz
Teva Investigational Site 32818
ACTIVE_NOT_RECRUITING
Dresden
Teva Investigational Site 32822
ACTIVE_NOT_RECRUITING
Düsseldorf
Teva Investigational Site 32825
ACTIVE_NOT_RECRUITING
Kassel
Teva Investigational Site 32826
RECRUITING
Leipzig
Teva Investigational Site 32824
ACTIVE_NOT_RECRUITING
Marburg
Teva Investigational Site 32820
ACTIVE_NOT_RECRUITING
München
Teva Investigational Site 32819
ACTIVE_NOT_RECRUITING
Münster
Teva Investigational Site 32821
ACTIVE_NOT_RECRUITING
Ulm
Israel
Teva Investigational Site 80203
ACTIVE_NOT_RECRUITING
Haifa
Teva Investigational Site 80215
ACTIVE_NOT_RECRUITING
Jerusalem
Teva Investigational Site 80204
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Teva Investigational Site 30299
ACTIVE_NOT_RECRUITING
Bologna
Teva Investigational Site 30297
ACTIVE_NOT_RECRUITING
Catania
Teva Investigational Site 30298
ACTIVE_NOT_RECRUITING
Milan
Teva Investigational Site 30294
ACTIVE_NOT_RECRUITING
Padova
Teva Investigational Site 30296
ACTIVE_NOT_RECRUITING
Roma
Teva Investigational Site 30295
ACTIVE_NOT_RECRUITING
Salerno
Japan
Teva Investigational Site 84140
ACTIVE_NOT_RECRUITING
Chiba
Teva Investigational Site 84139
ACTIVE_NOT_RECRUITING
Fuchū
Teva Investigational Site 84136
ACTIVE_NOT_RECRUITING
Gifu
Teva Investigational Site 84137
ACTIVE_NOT_RECRUITING
Niigata
Teva Investigational Site 84138
ACTIVE_NOT_RECRUITING
Sagamihara
Teva Investigational Site 84141
ACTIVE_NOT_RECRUITING
Sanda-shi
Teva Investigational Site 84135
ACTIVE_NOT_RECRUITING
Sendai
Spain
Teva Investigational Site 31328
RECRUITING
Barakaldo
Teva Investigational Site 31321
ACTIVE_NOT_RECRUITING
Barcelona
Teva Investigational Site 31323
ACTIVE_NOT_RECRUITING
Barcelona
Teva Investigational Site 31324
ACTIVE_NOT_RECRUITING
Barcelona
Teva Investigational Site 31329
RECRUITING
Elche
Teva Investigational Site 31327
ACTIVE_NOT_RECRUITING
Madrid
Teva Investigational Site 31330
RECRUITING
Madrid
Teva Investigational Site 31331
RECRUITING
Madrid
Teva Investigational Site 31320
ACTIVE_NOT_RECRUITING
Pamplona
Teva Investigational Site 31322
ACTIVE_NOT_RECRUITING
Seville
Teva Investigational Site 31319
ACTIVE_NOT_RECRUITING
Valencia
Contact Information
Primary
Teva U.S. Medical Information
USMedInfo@tevapharm.com
1-888-483-8279
Time Frame
Start Date: 2024-10-02
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 350
Treatments
Experimental: TEV-56286
Orally administered capsules once daily
Placebo_comparator: Placebo
Orally administered capsules once daily
Sponsors
Leads: Teva Branded Pharmaceutical Products R&D LLC

This content was sourced from clinicaltrials.gov