NCT06568237 A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
| NCT ID | NCT06568237 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Teva Branded Pharmaceutical Products R&D LLC |
| Condition | Multiple System Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2027-09-15 |
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 350 participants in total. It began in 2024-10-02 with a primary completion date of 2027-09-15.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: * is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria * is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination * Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits * Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods * 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 Exclusion Criteria: * has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA * 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 * has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening * is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study * has a known hypersensitivity to any components of the IMP * is of a vulnerable population (eg, people kept in detention or jail) * 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
Contact & Investigator
Tev Medical Expert, Study Director
STUDY DIRECTOR
Teva Branded Pharmaceutical Products R&D LLC
Frequently Asked Questions
Who can join the NCT06568237 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, 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 NCT06568237 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 NCT06568237 currently recruiting?
Yes, NCT06568237 is actively recruiting participants. Contact the research team at USMedInfo@tevapharm.com for enrollment information.
Where is the NCT06568237 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, Washington D.C., United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT06568237 clinical trial?
NCT06568237 is sponsored by Teva Branded Pharmaceutical Products R&D LLC. The principal investigator is Tev Medical Expert, Study Director at Teva Branded Pharmaceutical Products R&D LLC. The trial plans to enroll 350 participants.