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Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

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ClinicalTrials.gov Identifier: NCT03413319
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy (PSP) Drug: ABBV-8E12 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : October 19, 2020


Arm Intervention/treatment
Experimental: ABBV-8E12
ABBV-8E12 administered by intravenous (IV) infusion.
Drug: ABBV-8E12
Solution for infusion




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months) ]
    Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed Study C2N-8E12-WW-104 (NCT02494024)
  • Subject was not eligible to enroll in Study M15-562 (NCT02985879)

Exclusion Criteria:

  • Subject weighs less than 35 kg at screening
  • Subject has any contraindication or inability to tolerate brain MRI
  • Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results

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): NCT03413319


Locations
United States, California
University of California, San /ID# 170113
La Jolla, California, United States, 92093
United States, Texas
Texas Health Physicians Group /ID# 170112
Dallas, Texas, United States, 75218
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03413319     History of Changes
Other Study ID Numbers: M16-948
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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.: No

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms