RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-02

Study Completion:2027-06-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06568237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria * is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed * 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	* 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

Inclusion Criteria

Exclusion Criteria

* is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
* is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
* 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

* 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

Contacts and Locations

Study Contact

Teva U.S. Medical Information

CONTACT

1-888-483-8279

USMedInfo@tevapharm.com

Principal Investigator

Tev Medical Expert, Study Director

STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Study Locations (Sites)

Teva Investigational Site 15544

Boca Raton, Florida, 33486

United States

Teva Investigational Site 15543

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Tev Medical Expert, Study Director, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02

Study Completion Date2027-06-17

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2027-06-17

Terms related to this study

Additional Relevant MeSH Terms

Multiple System Atrophy