An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Purpose
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.
Condition
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TEV-56286 |
|
Recruiting Locations
Teva Investigational Site 15554
La Jolla, California 92037
La Jolla, California 92037
Teva Investigational Site 15544
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Teva Investigational Site 15555
Tampa, Florida 33613
Tampa, Florida 33613
Teva Investigational Site 15549
New York, New York 10016
New York, New York 10016
Teva Investigational Site 15551
New York, New York 10032-3726
New York, New York 10032-3726
Teva Investigational Site 15543
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC