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Trial of OnabotulinumtoxinA for Depression in Parkinson Disease

NCT03069911 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-06

No results posted yet for this study

Summary

This study evaluates the efficacy of onabotulinumtoxinA (BOTOX®) in the treatment of depression associated with Idiopathic Parkinson Disease in adults. As a Randomized Controlled Trial, half of the participants will receive onabotulinumtoxinA injections and half will receive a placebo saline solution.

Conditions

Interventions

BIOLOGICAL

OnabotulinumtoxinA

OnabotulinumtoxinA (29 units for women; 40 units for men) diluted with 0.9% sodium chloride (saline) solution to 40 units per milliliter (mL) (0.725 mL for women, 1 mL for men)

BIOLOGICAL

Control

0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)

Sponsors & Collaborators

Principal Investigators

  • Alexander Pantelyat, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-05-30
Completion
2019-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03069911 on ClinicalTrials.gov