A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
- Registration Number
- NCT06568237
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
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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
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is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
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Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
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Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
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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
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has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
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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
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has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
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is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
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has a known hypersensitivity to any components of the IMP
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is of a vulnerable population (eg, people kept in detention or jail)
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEV-56286 TEV-56286 Orally administered capsules once daily Placebo Placebo Orally administered capsules once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score Baseline to Week 48 The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes 11 items and item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Total UMSARS Score (Part I and Part II combined) Baseline to Week 48 The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. It is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value Up to Week 48 Change in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score Baseline to Week 48 The 40-item MSA-QoL questionnaire is self-administered and each item is rated on a Likert type scale (0: No problem) to (4: Extreme problem). It is comprised of 3 subscales relevant to MSA: motor (14 items), non-motor (12 items), and emotional/social (14 items). The MSA-QoL total score is the sum of all the items and lower scores indicate better QoL.
Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings Up to Week 48 Change From Baseline in the UMSARS Part 1 Score Baseline to Week 48 The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Part I includes a historical review of disease-related impairments, each item in part I achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
Change From Baseline in the Clinical Global Impression Scale - Severity (CGI-S) Baseline to Week 48 The CGI-S scale permits a global evaluation of the participant's current severity of illness on a Likert type scale ranging from 1 to 7, where 1=normal/not at all ill, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill participants.
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs) Up to Week 48 Number of Participants Who Withdraw From the Study Due to an Adverse Event Up to Week 48 Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value Up to Week 48 Number of Participants Who Withdraw From Treatment Due to an Adverse Event Up to Week 48
Trial Locations
- Locations (34)
Teva Investigational Site 15549
🇺🇸New York, New York, United States
Teva Investigational Site 15554
🇺🇸La Jolla, California, United States
Teva Investigational Site 15547
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 15544
🇺🇸Boca Raton, Florida, United States
Teva Investigational Site 15555
🇺🇸Tampa, Florida, United States
Teva Investigational Site 15546
🇺🇸Kansas City, Kansas, United States
Teva Investigational Site 15736
🇺🇸Boston, Massachusetts, United States
Teva Investigational Site 15552
🇺🇸Rochester, Minnesota, United States
Teva Investigational Site 15551
🇺🇸New York, New York, United States
Teva Investigational Site 15553
🇺🇸Durham, North Carolina, United States
Teva Investigational Site 15735
🇺🇸Hershey, Pennsylvania, United States
Teva Investigational Site 15543
🇺🇸Spokane, Washington, United States
Teva Investigational Site 35290
🇫🇷Bordeaux, France
Teva Investigational Site 35291
🇫🇷Salpetriere, France
Teva Investigational Site 35292
🇫🇷Toulouse, France
Teva Investigational Site 32818
🇩🇪Dresden, Germany
Teva Investigational Site 32822
🇩🇪Dusseldorf, Germany
Teva Investigational Site 32819
🇩🇪Muenster, Germany
Teva Investigational Site 32820
🇩🇪Munchen, Germany
Teva Investigational Site 80203
🇮🇱Haifa, Israel
Teva Investigational Site 80204
🇮🇱Tel-Aviv, Israel
Teva Investigational Site 30299
🇮🇹Bologna, Italy
Teva Investigational Site 30298
🇮🇹Milano, Italy
Teva Investigational Site 30296
🇮🇹Roma, Italy
Teva Investigational Site 30295
🇮🇹Salerno, Italy
Teva Investigational Site 84138
🇯🇵Sagamihara, Japan
Teva Investigational Site 84141
🇯🇵Sanda-shi, Japan
Teva Investigational Site 84135
🇯🇵Sendai, Japan
Teva Investigational Site 31323
🇪🇸Barcelona, Spain
Teva Investigational Site 31321
🇪🇸Barcelona, Spain
Teva Investigational Site 31324
🇪🇸Barcelona, Spain
Teva Investigational Site 31320
🇪🇸Pamplona, Spain
Teva Investigational Site 31322
🇪🇸Sevilla, Spain
Teva Investigational Site 31319
🇪🇸Valencia, Spain