Clinical trial NCT06568237: A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy (MSA)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, and Japan

Eligibility criteria: Inclusion 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

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

Primary outcomes:
measure: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
timeFrame: Baseline to Week 48
measure: Change From Baseline in the UMSARS Part 1 Score
timeFrame: Baseline to Week 48
measure: Change From Baseline in the Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Baseline to Week 48
measure: Change in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score
timeFrame: Baseline to Week 48
measure: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)
timeFrame: Up to Week 48
measure: Number of Participants Who Withdraw From the Study Due to an Adverse Event
timeFrame: Up to Week 48
measure: Number of Participants Who Withdraw From Treatment Due to an Adverse Event
timeFrame: Up to Week 48
measure: Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value
timeFrame: Up to Week 48
measure: Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value
timeFrame: Up to Week 48
measure: Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Teva Investigational Site 15554
state: California
city: Washington
country: United States
facility: Teva Investigational Site 15547
state: District of Columbia
city: Boca Raton
country: United States
facility: Teva Investigational Site 15544
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15555
state: Florida
city: Chicago
country: United States
facility: Teva Investigational Site 15550
state: Illinois
city: Kansas City
country: United States
facility: Teva Investigational Site 15546
state: Kansas
city: Boston
country: United States
facility: Teva Investigational Site 15736
state: Massachusetts
city: Rochester
country: United States
facility: Teva Investigational Site 15552
state: Minnesota
city: New York
country: United States
facility: Teva Investigational Site 15549
state: New York
city: New York
country: United States
facility: Teva Investigational Site 15551
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 15553
state: North Carolina
city: Hershey
country: United States
facility: Teva Investigational Site 15735
state: Pennsylvania
city: Spokane
country: United States
facility: Teva Investigational Site 15543
state: Washington
city: Bordeaux
country: France
facility: Teva Investigational Site 35290
city: Marseille Cedex 5
country: France
facility: Teva Investigational Site 35289
city: Salpetriere
country: France
facility: Teva Investigational Site 35291
city: Toulouse
country: France
facility: Teva Investigational Site 35292
city: Dresden
country: Germany
facility: Teva Investigational Site 32818
city: Dusseldorf
country: Germany
facility: Teva Investigational Site 32822
city: Kassel
country: Germany
facility: Teva Investigational Site 32825
city: Marburg
country: Germany
facility: Teva Investigational Site 32824
city: Muenster
country: Germany
facility: Teva Investigational Site 32819
city: Munchen
country: Germany
facility: Teva Investigational Site 32820
city: Haifa
country: Israel
facility: Teva Investigational Site 80203
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80204
city: Bologna
country: Italy
facility: Teva Investigational Site 30299
city: Milano
country: Italy
facility: Teva Investigational Site 30298
city: Roma
country: Italy
facility: Teva Investigational Site 30296
city: Salerno
country: Italy
facility: Teva Investigational Site 30295
city: Sagamihara
country: Japan
facility: Teva Investigational Site 84138
city: Sanda-shi
country: Japan
facility: Teva Investigational Site 84141
city: Sendai
country: Japan
facility: Teva Investigational Site 84135
city: Barcelona
country: Spain
facility: Teva Investigational Site 31323
city: Barcelona
country: Spain
facility: Teva Investigational Site 31321
city: Barcelona
country: Spain
facility: Teva Investigational Site 31324
city: Pamplona
country: Spain
facility: Teva Investigational Site 31320
city: Sevilla
country: Spain
facility: Teva Investigational Site 31322
city: Valencia
country: Spain
facility: Teva Investigational Site 31319
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Tev Medical Expert, Study Director
role: STUDY_DIRECTOR
References: