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NCT04539041 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy

A Phase 1 study of Progressive Supranuclear Palsy (PSP), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
59
Enrollment target
12
Study locations

NCT04539041: Completed Phase 1 study of Progressive Supranuclear Palsy (PSP), sponsored by Novartis Pharmaceuticals.

NCT04539041 is a Phase 1 study of Progressive Supranuclear Palsy (PSP) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 687-participant average among 5 other Progressive Supranuclear Palsy (PSP) trials with a reported enrollment target (91% lower). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04539041, a Phase 1 study of Progressive Supranuclear Palsy (PSP), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
59 participants
Enrollment target
12
Study locations

Study Summary

This is a phase 1, multi-center, double-blind, placebo-controlled, multiple dose escalation study with NIO752 in progressive supranuclear palsy (PSP) participants.

Primary Outcome

Adverse events will be collected at clinical visits and other contacts. All abnormalities from safety assessments (physical exams and neurological exams and clinical safety labs) considered clinically significant will be recorded as adverse events

Interventions

  • DRUG placebo
  • DRUG antisense oligonucleotide

Study Locations (12)

Other

  • Novartis Investigative Site - Düsseldorf
  • Novartis Investigative Site - Hanover
  • Novartis Investigative Site - München
  • Novartis Investigative Site - Tübingen
  • Novartis Investigative Site - Ulm
  • Novartis Investigative Site - Southampton

Quebec

  • Novartis Investigative Site - Montreal
  • Novartis Investigative Site - Montreal

California

  • University of California San Diego - La Jolla

Minnesota

  • Mayo Clinic Rochester - Rochester

Tennessee

  • Vanderbilt University Medical CenterX - Nashville

North Rhine-Westphalia

  • Novartis Investigative Site - Bonn

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2021-02-16
Est. Completion 2024-10-17
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT04539041 record still lists

NCT04539041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 687-participant average among 5 other Progressive Supranuclear Palsy (PSP) trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Progressive Supranuclear Palsy (PSP) appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT04539041 lists 12 locations in 6 states (Other, Quebec, California).

Frequently Asked Questions

What is clinical trial NCT04539041 about?

NCT04539041 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy". This is a phase 1, multi-center, double-blind, placebo-controlled, multiple dose escalation study with NIO752 in progressive supranuclear palsy (PSP) participants.

What is the current status of trial NCT04539041?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2021-02-16. Estimated completion is 2024-10-17.

What conditions does trial NCT04539041 study?

This clinical trial studies the following conditions: Progressive Supranuclear Palsy (PSP).

What interventions are being tested in trial NCT04539041?

The interventions under investigation include: placebo (DRUG), antisense oligonucleotide (DRUG).

Who is sponsoring clinical trial NCT04539041?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04539041 being conducted?

This trial has 12 study locations across California, Minnesota, Tennessee, Quebec, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04539041, the US trial registry maintained by the National Library of Medicine. NCT04539041 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.