Parkinson DiseasePhase 1NCT03069911
Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
A Phase 1 study testing OnabotulinumtoxinA in people with Parkinson Disease and Depression, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
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.
Read the detailed description
Depression is a common, but treatable, comorbid condition often seen in persons with Idiopathic Parkinson Disease (iPD). Depression in Parkinson Disease may be hard to treat as patients with iPD may be sensitive to side effect of medication. As a result, other treatments which have better side effects profiles than antidepressants may be equivalent (or better) options.
OnabotulinumtoxinA is a purified formulation of botulinum toxin serotype A which is widely utilized for neurological (and cosmetic) purposes in medicine. OnabotulinumtoxinA has preliminary studies showing it may be beneficial for the treatment of Major Depressive Disorder when given in isolated injections to facial muscles (corrugator and procerus). When given in low doses, onabotulinumtoxinA is thought to have minimal side effects.
The investigators propose that a single treatment onabotulinumtoxinA may improve symptoms of depression in persons with Parkinson Disease over three months compared to placebo. The investigators plan to use both subjective and objective evaluations of depression symptoms and regular physical exams to ensure physical (motor) symptoms of Parkinson Disease do not worsen.
- Conditions
- Parkinson Disease, Depression
- Being tested
- OnabotulinumtoxinA, Control
- Keywords
- Parkinson Disease, Parkinsonism, Depression, OnabotulinumtoxinA, BOTOX
- Medical subject headings
- Parkinson Disease, Depression, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinABiological
Also called Botox, Botulinum Toxin Type A
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)
ControlBiological
Also called Normal saline
0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: OnabotulinumtoxinA |
| Control | Placebo comparator | One injection of saline solution will be injected into two facial muscles - the corrugator and procerus. Receives: Biological: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and two visits over three months (weeks 6 and 12)
Secondary outcomes (1)
Clinical Severity Score for Glabellar Frown Lines
Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
Measured: Baseline and two visits over three months (weeks 6 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Nov 2018
- Primary completion30 May 2019
- Study completion1 Jun 2019
Why it stopped: Unable to recruit required participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Pantelyat, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069911
- Sponsor's protocol ID
- IRB00082708
- Status last verified
- Aug 2019
- First submitted
- 28 Feb 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified group data will be shared between the two study sites (Johns Hopkins and NIH)
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
- ClinicalTrials.gov ID
- NCT03069911
- Acronym / sponsor ID
- IRB00082708
- Conditions
- Parkinson Disease, Depression
- Keywords
- Parkinson Disease, Parkinsonism, Depression, OnabotulinumtoxinA, BOTOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit required participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression is a common, but treatable, comorbid condition often seen in persons with Idiopathic Parkinson Disease (iPD). Depression in Parkinson Disease may be hard to treat as patients with iPD may be sensitive to side effect of medication. As a result, other treatments which have better side effects profiles than antidepressants may be equivalent (or better) options.
OnabotulinumtoxinA is a purified formulation of botulinum toxin serotype A which is widely utilized for neurological (and cosmetic) purposes in medicine. OnabotulinumtoxinA has preliminary studies showing it may be beneficial for the treatment of Major Depressive Disorder when given in isolated injections to facial muscles (corrugator and procerus). When given in low doses, onabotulinumtoxinA is thought to have minimal side effects.
The investigators propose that a single treatment onabotulinumtoxinA may improve symptoms of depression in persons with Parkinson Disease over three months compared to placebo. The investigators plan to use both subjective and objective evaluations of depression symptoms and regular physical exams to ensure physical (motor) symptoms of Parkinson Disease do not worsen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: OnabotulinumtoxinAOne injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus. |
| Control | Placebo comparator | Biological: ControlOne injection of saline solution will be injected into two facial muscles - the corrugator and procerus. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: Botox, Botulinum Toxin Type AOnabotulinumtoxinA (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 | Intervention |
| ControlAlso: Normal saline0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men) | Biological | Control |
Primary outcome
Hamilton Rating Scale for Depression (HDRS)
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)
Clinical Global Impression - Improvement (CGI-I)
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Improvement on a measure of global change from screening to study discontinuation
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Improvement on measure of global illness severity from screening to study discontinuation
Beck Depression Inventory II
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Improvement on a participant-rated subjective scale for depression as assessed over two visits
1 secondary outcome
Clinical Severity Score for Glabellar Frown Lines
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Results and safety
The study was stopped early (reason given: Unable to recruit required participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No. Deidentified group data will be shared between the two study sites (Johns Hopkins and NIH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Pantelyat, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OnabotulinumtoxinA in people with Parkinson Disease and Depression, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit required participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HDRS) (time frame: Baseline and two visits over three months (weeks 6 and 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.