An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT03391765
• Date of registration: 02/01/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
• Scientific title: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
• Date of first enrolment: January 24, 2018
• Target sample size: 142
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03391765
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, France, Italy, Japan, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

- In the opinion of the investigator, the participant was compliant during participation
in Study M15-562 (NCT02985879)

- Participant has an identified, reliable, study partner (e.g., caregiver, family
member, social worker, or friend)

Exclusion Criteria:

- Participants who weigh less than 44 kg (97 lbs) at the time of study entry

- Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

- Participant 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

- More than 8 weeks have elapsed since the participant received his/her last dose of
study drug in Study M15-562 (NCT02985879)

- Participant is considered by the investigator, for any reason, to be an unsuitable
candidate to receive ABBV-8E12 or the participant is considered by the investigator to
be unable or unlikely to comply with the dosing schedule or study evaluations



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy (PSP)

Intervention(s)

Drug: Placebo solution for IV infusion on Day 15

Drug: ABBV-8E12

Primary Outcome(s)

Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [Time Frame: Baseline, Week 52]

Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) [Time Frame: Baseline, Week 52]

Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52 [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score [Time Frame: Baseline, Week 52]

Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 [Time Frame: From Baseline to Week 52]

Secondary ID(s)

2017-001590-16

M15-563

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03391765