A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy Safety and Efficacy Study
- Conditions
- Multiple System Atrophy
- Registration Number
- NCT06568237
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> - is considered to be clinically possible or clinically probable MSA as determined<br> by the Gilman criteria<br><br> - is able to ambulate at least 10 meters without the assistance of another person at<br> screening; the use of assistive device (eg, cane, not walker) is allowed<br><br> - is medically and psychiatrically stable, as indicated by medical and psychiatric<br> history, as well as physical and neurological examination<br><br> - Females of child bearing potential (CBP) may be included only if they have a<br> negative pregnancy test at the screening and baseline visits<br><br> - Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must<br> use highly effective birth control methods<br><br> - Males who are potentially fertile/reproductively competent (not surgically [eg,<br> vasectomy] or congenitally sterile) and their female partners who are of CBP must<br> use, together with their female partners, highly effective birth control methods<br><br> - Additional criteria apply; please contact the investigator for more information<br><br>Exclusion Criteria:<br><br> - has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis<br> other than MSA<br><br> - has participated in another clinical study involving administration of an IMP within<br> 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening<br><br> - has a history of, or acknowledges, alcohol or other substance abuse in the 12 months<br> before screening<br><br> - is a female participant who is pregnant or breastfeeding, or plans to become<br> pregnant during the study<br><br> - has a known hypersensitivity to any components of the IMP<br><br> - is of a vulnerable population (eg, people kept in detention or jail)<br><br> - participant is using or consuming any prohibited concomitant medications within the<br> specified exclusionary windows of this study<br><br> - Additional criteria apply; please contact the investigator for more information
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Total UMSARS Score (Part I and Part II combined);Change From Baseline in the UMSARS Part 1 Score;Change From Baseline in the Clinical Global Impression Scale - Severity (CGI-S);Change in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score;Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs);Number of Participants Who Withdraw From the Study Due to an Adverse Event;Number of Participants Who Withdraw From Treatment Due to an Adverse Event;Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value;Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value;Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings