RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY
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|ClinicalTrials.gov Identifier: NCT04937530|
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Progressive Supranuclear Palsy||Drug: RT001 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Progressive Supranuclear Palsy|
|Actual Study Start Date :||June 23, 2021|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||August 30, 2022|
RT001 960 mg capsule. 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
RT001 8.64 g/d (3 capsules TID) for 1 month followed by 5.76 g/d (3 capsules BID) for an additional 11 months
Other Name: di-deuterated linoleic acid ester
Placebo Comparator: Placebo
Inactive comparator capsule 960 mg (safflower oil). 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
Placebo Comparator: Placebo Inactive comparator capsule 960 mg/capsule: 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
Other Name: safflower oil
- Change from baseline in the PSPRS-28 at 48 weeks for the RT001 treated group vs placebo-treated group [ Time Frame: 48 weeks ]The PSPRS-28 is a clinician-rated instrument to assess disability and severity of PSP. The PSPRS-28 evaluates 28 items in six categories: daily activities (by history), behavior, bulbar, ocular motor, limb motor and gait/midline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937530
|Contact: Mark G. Midei, MD||(650) email@example.com|
|Agaharied Teaching Hospital, University of Munich||Recruiting|
|Munich, MD, Germany, 21111|
|Contact: Mark G. Midei, MD firstname.lastname@example.org|
|Principal Investigator:||Stefan Lorenzl, MD, PhD||Ludwig-Maximilians - University of Munich|