NCT03391765

An Extension Study of an Active Drug in Progressive Supranuclear Palsy (PSP)

Brief summary

The purpose of this study is to assess the long-term safety and efficacy of an active drug in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.

Interventional study

Status:
Terminated
Conditions:
Progressive Supranuclear Palsy (PSP)
Enrollment:
142 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-563
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
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Eligibility criteria

Participant attributes:
Male and Female

Age:

40 Years and older.

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

All the cities where the clinical studies are located

Montreal - H3A 2B4
Montréal - H2X 0A9

Alberta

Ontario

Quebec