NCT07197866 An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
| NCT ID | NCT07197866 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Teva Branded Pharmaceutical Products R&D LLC |
| Condition | Multiple System Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2029-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-09-30 with a primary completion date of 2029-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Teva Medical Expert, MD
STUDY DIRECTOR
Teva Branded Pharmaceutical Products R&D LLC
Frequently Asked Questions
Who can join the NCT07197866 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Multiple System Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07197866 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07197866 currently recruiting?
Yes, NCT07197866 is actively recruiting participants. Contact the research team at USMedInfo@tevapharm.com for enrollment information.
Where is the NCT07197866 trial being conducted?
This trial is being conducted at La Jolla, United States, Boca Raton, United States, Tampa, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT07197866 clinical trial?
NCT07197866 is sponsored by Teva Branded Pharmaceutical Products R&D LLC. The principal investigator is Teva Medical Expert, MD at Teva Branded Pharmaceutical Products R&D LLC. The trial plans to enroll 200 participants.