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

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ClinicalTrials.gov Identifier: NCT04127695
Recruitment Status : Withdrawn (Strategic considerations)
First Posted : October 15, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ABBV-0805 Drug: Placebo ABBV-0805 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2020
Actual Primary Completion Date : June 16, 2020
Actual Study Completion Date : June 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABBV-0805 Dose 1 or Placebo
Participants will receive ABBV-0805 Dose 1 or Placebo.
Drug: ABBV-0805
ABBV-0805 administered by IV infusion.

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

Experimental: ABBV-0805 Dose 2 or Placebo
Participants will receive ABBV-0805 Dose 2 or Placebo.
Drug: ABBV-0805
ABBV-0805 administered by IV infusion.

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

Experimental: ABBV-0805 Dose 3 or Placebo
Participants will receive ABBV-0805 Dose 3 or Placebo.
Drug: ABBV-0805
ABBV-0805 administered by IV infusion.

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

Experimental: ABBV-0805 Dose 4 or Placebo
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.
Drug: ABBV-0805
ABBV-0805 administered by IV infusion.

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




Primary Outcome Measures :
  1. 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.

  2. Maximum Observed Serum Concentration (Cmax) [ Time Frame: Day 1 through Day 29 and Day 85 through Day 113 ]
    Maximum Serum Concentration of ABBV-0805.

  3. 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).

  4. 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.

  5. Apparent Terminal Phase Elimination Rate Constant (Beta) [ Time Frame: Day 1 through Day 176 ]
    Apparent terminal phase elimination rate constant (Beta) for ABBV-0805.

  6. Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF) [ Time Frame: Day 113 ]
    Concentration of ABBV-0805 in CSF.

  7. Terminal Phase Elimination half-life (t1/2) [ Time Frame: Day 1 through Day 176 ]
    Terminal phase elimination half-life (t1/2).

  8. Serum Concentration (Ctrough) [ Time Frame: Day 29, Day 57, Day 85, Day 113 ]
    Ctrough concentration of ABBV-0805.

  9. Total clearance (CL) [ Time Frame: Day 1 through Day 176 ]
    Clearance of ABBV-0805.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127695


Locations
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United States, California
University of California, San /ID# 212549
San Diego, California, United States, 92037
United States, Florida
University of Florida - Archer /ID# 212823
Gainesville, Florida, United States, 32610
University of South Florida /ID# 214286
Tampa, Florida, United States, 33612
United States, New York
Columbia Univ Medical Center /ID# 212826
New York, New York, United States, 10032-3725
United States, North Carolina
Duke University Medical Center /ID# 214435
Durham, North Carolina, United States, 27705-4410
United States, Texas
UT Health Science Ctr-Houston /ID# 213029
Houston, Texas, United States, 77030
United States, Washington
Evergreen Neuroscience Institute /ID# 212827
Kirkland, Washington, United States, 98034-3029
Inland Northwest Research /ID# 212119
Spokane, Washington, United States, 99202-1342
Puerto Rico
University of Puerto Rico, Medical Sciences Campus /ID# 215751
Rio Piedras, Puerto Rico, 00935
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04127695    
Other Study ID Numbers: M19-304
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases