RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY

NCT04937530 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-25

No results posted yet for this study

Summary

This is a randomized, placebo-controlled trial of RT001 in patients with PSP.

Conditions

Interventions

DRUG

RT001

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

DRUG

Placebo

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.

Sponsors & Collaborators

  • Biojiva LLC

    lead INDUSTRY

Principal Investigators

  • Stefan Lorenzl, MD, PhD · Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2022-07-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04937530 on ClinicalTrials.gov