A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study (TOPAS-MSA)

Teva Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Multiple System Atrophy

Treatments: Drug: Placebo; Drug: TEV-56286

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568237

TV56286-NDG-20039

2023-505320-54-00 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Enrollment: 200 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

TEV-56286

Experimental group

Description:

Orally administered capsules once daily

Treatment:

Drug: TEV-56286

Placebo

Placebo Comparator group

Description:

Orally administered capsules once daily

Treatment:

Drug: Placebo