Trial of OnabotulinumtoxinA for Depression in Parkinson Disease

NCT03069911 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IRB00082708
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson Disease; Depression

Keywords

Parkinson Disease; Parkinsonism; Depression; OnabotulinumtoxinA; BOTOX

Outcome Measures

Primary Outcomes (4)

• Hamilton Rating Scale for Depression (HDRS)

  Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)

  Baseline and two visits over three months (weeks 6 and 12)

• Clinical Global Impression - Improvement (CGI-I)

  Improvement on a measure of global change from screening to study discontinuation

  Baseline and two visits over three months (weeks 6 and 12)

• Clinical Global Impression - Severity (CGI-S)

  Improvement on measure of global illness severity from screening to study discontinuation

  Baseline and two visits over three months (weeks 6 and 12)

• Beck Depression Inventory II

  Improvement on a participant-rated subjective scale for depression as assessed over two visits

  Baseline and two visits over three months (weeks 6 and 12)

Secondary Outcomes (1)

• Clinical Severity Score for Glabellar Frown Lines

  Baseline and two visits over three months (weeks 6 and 12)

Study Arms (2)

Intervention

EXPERIMENTAL

One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.

Biological: OnabotulinumtoxinA

Control

PLACEBO COMPARATOR

One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.

Biological: Control

Interventions

OnabotulinumtoxinA BIOLOGICAL

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)

Also known as: Botox, Botulinum Toxin Type A

Intervention

Control BIOLOGICAL

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

Also known as: Normal saline

Control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent is obtained in the English language;
• They are a 18 to 95 years old;
• They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
• They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
• They are judged by the investigator to have the capacity to understand the nature of the study;
• They are willing to comply with all the requirements of the study;
• They are considered by the investigator to be likely to adhere to the protocol.

You may not qualify if:

• They have been treated with onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
• They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
• They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
• They have a history of substance abuse or dependence in the 2 months prior to screening;
• They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
• They are considered to be at significant risk of committing homicide;
• They have an unstable medical condition;
• Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
• There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
• They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Depression; Parkinsonian Disorders

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alexander Pantelyat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: November 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: June 1, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)