Trial · NCT03391765
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
NCT03391765, Phase 2, Terminated, AbbVie; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP). Trials, record NCT03391765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03391765
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
- NCT number
- NCT03391765
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Progressive Supranuclear Palsy (PSP)
- Interventions
- ABBV-8E12, Placebo solution for IV infusion on Day 15
- First posted
- 2018-01-05
- Last updated
- 2021-02-03
- Other registries' IDs
- eudract:2017-001590-16
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | Baseline, Week 52 | The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline. |
| Secondary | Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | Baseline, Week 52 | The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive values indicate worsening from baseline. |
| Secondary | Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 | Baseline, Week 52 | The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. |
| Secondary | Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) | Baseline, Week 52 | The Schwab and England Activities of Daily Living (SEADL) scale consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative values indicate worsening from baseline. |
| Secondary | Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score | Baseline, Week 52 | The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive values indicate worsening from baseline. |
| Secondary | Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52 | Baseline, Week 52 | The PGI-C is a participant's rating of the change in their PSP-related symptoms since initiation of study drug. Participants rated their change in status using the following 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. |
| Secondary | Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score | Baseline, Week 52 | The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive values indicate worsening from baseline. |
| Secondary | Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 | From Baseline to Week 52 | The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52 | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score | Baseline, Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | units on a scale | MEAN |
| SECONDARY | Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 | From Baseline to Week 52 | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data | days | MEDIAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 14.4 | Standard Deviation 7.73 | units on a scale | |
| Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 2.3 | Standard Deviation 11.99 | units on a scale | |
| Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 13.1 | Standard Deviation 6.87 | units on a scale | |
| Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 4.2 | Standard Deviation 6.40 | units on a scale | |
| Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 6.9 | Standard Deviation 4.37 | units on a scale | |
| Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 3.2 | Standard Deviation 5.27 | units on a scale | |
| Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 5.6 | Standard Deviation 5.68 | units on a scale | |
| Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 7.3 | Standard Deviation 6.28 | units on a scale | |
| Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | Baseline of M15-563 | 5.0 | Standard Deviation 0.89 | units on a scale |
| Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | Baseline of M15-563 | 4.8 | Standard Deviation 0.92 | units on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 51 | |
| Overall Study | STARTED | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 45 | |
| Overall Study | STARTED | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 23 | |
| Overall Study | STARTED | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 23 | |
| Overall Study | COMPLETED | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 0 | |
| Overall Study | COMPLETED | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 0 | |
| Overall Study | COMPLETED | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 0 | |
| Overall Study | COMPLETED | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 0 | |
| Overall Study | NOT COMPLETED | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 51 | |
| Overall Study | NOT COMPLETED | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CONSTIPATION | Gastrointestinal disorders | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 4 | 51 | 4 |
| other | CONSTIPATION | Gastrointestinal disorders | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 2 | 45 | 2 |
| other | CONSTIPATION | Gastrointestinal disorders | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 0 | 23 | 0 |
| other | CONSTIPATION | Gastrointestinal disorders | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 2 | 23 | 2 |
| other | DYSPHAGIA | Gastrointestinal disorders | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 2 | 51 | 2 |
| other | DYSPHAGIA | Gastrointestinal disorders | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 1 | 45 | 1 |
| other | DYSPHAGIA | Gastrointestinal disorders | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 0 | 23 | 0 |
| other | DYSPHAGIA | Gastrointestinal disorders | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 3 | 23 | 3 |
| other | ASTHENIA | General disorders | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 1 | 51 | 1 |
| other | ASTHENIA | General disorders | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 0 | 45 | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 5 | 51 |
| Total, all-cause mortality | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 5 | 45 |
| Total, all-cause mortality | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 1 | 23 |
| Total, all-cause mortality | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 2 | 23 |
| Total, other adverse events | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 18 | 51 |
| Total, other adverse events | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 16 | 45 |
| Total, other adverse events | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 6 | 23 |
| Total, other adverse events | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 16 | 23 |
| Total, serious adverse events | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 10 | 51 |
| Total, serious adverse events | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 10 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03391765
GET https://conductscience.org/api/trials/v1/NCT03391765/results?page=2