A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for the Treatment of Multiple System Atrophy

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of TEV-56286, also known as ANLE138b, in adult patients with MSA ( Multiple System Atrophy).  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/15/2024. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Contact us for the latest status

Contact information:

Raelene Martini

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available