Multiple System Atrophy
Conditions
Brief summary
The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286. The planned total duration of the trial is approximately 100 weeks.
Interventions
DRUGTEV-56286
administered orally
Sponsors
Teva Branded Pharmaceutical Products R&D LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements * Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit * Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP * Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product NOTE - Additional criteria apply, please contact the investigator for more information
Exclusion criteria
* Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial * Is of a vulnerable population (eg, people kept in detention or jail) * Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial Note - Additional criteria apply, please contact the investigator for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing an adverse event | Baseline to Week 100 |
| Number of participants who withdrew from the trial due to an adverse event | Baseline to Week 100 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with potentially clinically significant vital sign values | Baseline to Week 96 |
| Number of participants with potentially clinically significant laboratory test values (hematology and chemistry) | Baseline to Week 96 |
| Number of participants with potentially clinically significant 12-lead ECG measurements | Baseline to Week 96 |
Countries
France, Germany, Israel, Italy, Japan, Spain, United States
Contacts
CONTACTTeva U.S. Medical Information
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Outcome results
None listed