A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease

A Phase 1 study testing ABBV-0805 in people with Parkinson's Disease, run by AbbVie at 6 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study will evaluate the safety and tolerability of ABBV-0805 in adult participants with Parkinson's Disease and results from it will help guide the design of future clinical studies. ABBV-0805 is administered every 28 days by intravenous (IV) infusion. Read more about this study

Who is it for?: Ages Up to 85 years
Conditions the study is for: Parkinson's Disease
What is being tested?: ABBV-0805
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 6 sitesin 2 countries
Study dates: 3 Mar 2020to 16 Jun 2020
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 Up to 85 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosed with idiopathic Parkinson's Disease (PD) within 5 years and with modified Hoehn and Yahr Stage of less than 3 at Screening.
Body Mass Index (BMI) is >= 18.0 to <=35.0 kg/m2.
Participant must follow protocol-specific methods of contraception, if applicable.
Participant must be in general good health (except for PD) based upon results of medical history, physical examination, vital signs, laboratory testing, neurological examination and 12-lead electrocardiogram (ECG).
Note: If participant is taking standard of care medication for treatment of PD, doses must be stable for at least 30 days prior to starting study drug and participant should not have any clinically relevant motor fluctuations.

Who cannot join

Participant with a history of, or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space occupying lesion (such as an abscess or brain tumor such as meningioma).
Received any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study administration, unless approved by the Investigator in consultation with the AbbVie Therapeutic Area Medical Director.
Treated with any investigational product within a time frame equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to the first dose of study drug.
Participant with recent history of drug or alcohol abuse (within 6 months prior to study drug administration) that could impact adherence to the protocol in the opinion of the investigator.
Participant with evidence of dysplasia or history of malignancy with the exception of excised or treated cervical cancer, some indolent malignancies (such as basal cell carcinoma or squamous cell carcinomas), remission from any malignancy for more than 5 years or participants with slow growth prostatic carcinoma may be eligible to participate with the permission of the AbbVie TA MD.
Participant with history of seizure disorder or unexplained blackouts or history of a seizure within 6 months.

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Participant with congenital structural or conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmias or other cardiac conditions.
Participant with varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before randomization.
Received any live vaccine within 4 weeks prior to the first dose of study drug, including but not limited to: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine.
Participant with symptoms of an active infection or history of prior infection (viral, fungal, or bacterial) requiring hospitalization or IV antibiotics within 8 weeks before first dose of study drug.
Participant with history of abnormal laboratory result that, in the opinion of the investigator, are indicative of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological, and/or other major disease.
Participant with contraindications to lumbar puncture (such as lumbar scoliosis, coagulopathy, infected skin at needle puncture site). Use of anticoagulants may be allowed in the study but must be temporarily suspended prior to and after lumbar puncture.
Participant with contraindications to MRI (such as aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker), are allergic to gadolinium, or have claustrophobia.
Participant currently enrolled in another interventional clinical study. Participants enrolled in non-interventional studies may be eligible to participate at the discretion of the AbbVie TA MD.
Participant with clinically significant and/or unstable medical conditions or any other reason that the Investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive ABBV-0805.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

Duke University Medical Center /ID# 214435
Durham, North Carolina, 27705-4410
University of Florida - Archer /ID# 212823
Gainesville, Florida, 32610
Evergreen Neuroscience Institute /ID# 212827
Kirkland, Washington, 98034-3029
Columbia Univ Medical Center /ID# 212826
New York, New York, 10032-3725
Inland Northwest Research /ID# 212119
Spokane, Washington, 99202-1342

Other trials in United States

Puerto Rico1 site

University of Puerto Rico, Medical Sciences Campus /ID# 215751
Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease

Conditions: Parkinson's Disease
Being tested: ABBV-0805, Placebo ABBV-0805
Keywords: Parkinson's Disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBV-0805Drug
ABBV-0805 administered by IV infusion.
Placebo ABBV-0805Drug
Placebo ABBV-0805 administered by IV infusion.

Study groups in NCT04127695
Study group	Role	What they receive
ABBV-0805 Dose 1 or Placebo	Experimental	Participants will receive ABBV-0805 Dose 1 or Placebo. Receives: Drug: ABBV-0805; Drug: Placebo ABBV-0805
ABBV-0805 Dose 2 or Placebo	Experimental	Participants will receive ABBV-0805 Dose 2 or Placebo. Receives: Drug: ABBV-0805; Drug: Placebo ABBV-0805
ABBV-0805 Dose 3 or Placebo	Experimental	Participants will receive ABBV-0805 Dose 3 or Placebo. Receives: Drug: ABBV-0805; Drug: Placebo ABBV-0805
ABBV-0805 Dose 4 or Placebo	Experimental	Participants will receive ABBV-0805 Dose 4 or Placebo. Note: This dosing group may be added after a review of data from dosing groups 1-3. Receives: Drug: ABBV-0805; Drug: Placebo ABBV-0805

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Measured: Day 1 through Day 260
Maximum Observed Serum Concentration (Cmax)
Maximum Serum Concentration of ABBV-0805.
Measured: Day 1 through Day 29 and Day 85 through Day 113
Time to Cmax (peak time, Tmax)
Time to Cmax (peak time, Tmax).
Measured: Day 1 through Day 29 and Day 85 through Day 113
Area under the Serum Concentration Time curve (AUC)
Area Under the Serum Concentration Time Curve at first and final dose.
Measured: Day 1 through Day 29 and Day 85 through Day 113
Apparent Terminal Phase Elimination Rate Constant (Beta)
Apparent terminal phase elimination rate constant (Beta) for ABBV-0805.
Measured: Day 1 through Day 176
Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF)
Concentration of ABBV-0805 in CSF.
Measured: Day 113
Terminal Phase Elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2).
Measured: Day 1 through Day 176
Serum Concentration (Ctrough)
Ctrough concentration of ABBV-0805.
Measured: Day 29, Day 57, Day 85, Day 113
Total clearance (CL)
Clearance of ABBV-0805.
Measured: Day 1 through Day 176

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202016 Jun 2020

First posted15 Oct 2019
Study start3 Mar 2020
Primary completion16 Jun 2020
Study completion16 Jun 2020

Why it stopped: Strategic considerations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by AbbVieThe 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: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04127695
Sponsor's protocol ID: M19-304
Status last verified: Dec 2021
First submitted: 9 Oct 2019
Last updated: 15 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT04127695
Acronym / sponsor ID: M19-304
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategic considerations
Enrolment: 0 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 3 Mar 2020 (actual)
Primary completion: 16 Jun 2020 (actual)
Study completion: 16 Jun 2020 (actual)
First posted: 15 Oct 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
ABBV-0805 Dose 1 or Placebo	Experimental	Drug: ABBV-0805, Drug: Placebo ABBV-0805Participants will receive ABBV-0805 Dose 1 or Placebo.
ABBV-0805 Dose 2 or Placebo	Experimental	Drug: ABBV-0805, Drug: Placebo ABBV-0805Participants will receive ABBV-0805 Dose 2 or Placebo.
ABBV-0805 Dose 3 or Placebo	Experimental	Drug: ABBV-0805, Drug: Placebo ABBV-0805Participants will receive ABBV-0805 Dose 3 or Placebo.
ABBV-0805 Dose 4 or Placebo	Experimental	Drug: ABBV-0805, Drug: Placebo ABBV-0805Participants will receive ABBV-0805 Dose 4 or Placebo. Note: This dosing group may be added after a review of data from dosing groups 1-3.

Who may qualify

Ages: Up to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosed with idiopathic Parkinson's Disease (PD) within 5 years and with modified Hoehn and Yahr Stage of less than 3 at Screening.
Body Mass Index (BMI) is >= 18.0 to <=35.0 kg/m2.
Participant must follow protocol-specific methods of contraception, if applicable.
Participant must be in general good health (except for PD) based upon results of medical history, physical examination, vital signs, laboratory testing, neurological examination and 12-lead electrocardiogram (ECG).
Note: If participant is taking standard of care medication for treatment of PD, doses must be stable for at least 30 days prior to starting study drug and participant should not have any clinically relevant motor fluctuations.

Key exclusion criteria (15 listed)

Participant with a history of, or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space occupying lesion (such as an abscess or brain tumor such as meningioma).
Received any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study administration, unless approved by the Investigator in consultation with the AbbVie Therapeutic Area Medical Director.
Treated with any investigational product within a time frame equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to the first dose of study drug.
Participant with recent history of drug or alcohol abuse (within 6 months prior to study drug administration) that could impact adherence to the protocol in the opinion of the investigator.
Participant with evidence of dysplasia or history of malignancy with the exception of excised or treated cervical cancer, some indolent malignancies (such as basal cell carcinoma or squamous cell carcinomas), remission from any malignancy for more than 5 years or participants with slow growth prostatic carcinoma may be eligible to participate with the permission of the AbbVie TA MD.

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
ABBV-0805ABBV-0805 administered by IV infusion.	Drug	ABBV-0805 Dose 1 or Placebo, ABBV-0805 Dose 2 or Placebo, ABBV-0805 Dose 3 or Placebo, ABBV-0805 Dose 4 or Placebo
Placebo ABBV-0805Placebo ABBV-0805 administered by IV infusion.	Drug	ABBV-0805 Dose 1 or Placebo, ABBV-0805 Dose 2 or Placebo, ABBV-0805 Dose 3 or Placebo, ABBV-0805 Dose 4 or Placebo

Primary outcome

Number of Participants with Adverse Events
Time frame: Day 1 through Day 260
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Maximum Serum Concentration of ABBV-0805.
Time to Cmax (peak time, Tmax)
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Time to Cmax (peak time, Tmax).
Area under the Serum Concentration Time curve (AUC)
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Area Under the Serum Concentration Time Curve at first and final dose.
Apparent Terminal Phase Elimination Rate Constant (Beta)
Time frame: Day 1 through Day 176
Apparent terminal phase elimination rate constant (Beta) for ABBV-0805.
Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF)
Time frame: Day 113
Concentration of ABBV-0805 in CSF.
Terminal Phase Elimination half-life (t1/2)
Time frame: Day 1 through Day 176
Terminal phase elimination half-life (t1/2).
Serum Concentration (Ctrough)
Time frame: Day 29, Day 57, Day 85, Day 113
Ctrough concentration of ABBV-0805.
Total clearance (CL)
Time frame: Day 1 through Day 176
Clearance of ABBV-0805.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
Individual participant dataSharing planned: No

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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Adaptive DBS to Offset STN Dysregulation During Exercise in PD
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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.

ABBVIE INC. study director

AbbVie

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-0805 in people with Parkinson's Disease, run by AbbVie at 6 sites in 2 countries.

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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Puerto Rico. 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. 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 withdrawn before enrolling participants, so there are no results.

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?

Number of Participants with Adverse Events (time frame: Day 1 through Day 260). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04127695.

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 15 Dec 2021.