Trial · NCT04431713
Exenatide Once-weekly as a Treatment for Multiple System Atrophy
NCT04431713, Phase 2, Completed, University College, London; results first posted 2025-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exenatide Once-weekly as a Treatment for Multiple System Atrophy. Trials, record NCT04431713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04431713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exenatide Once-weekly as a Treatment for Multiple System Atrophy
- NCT number
- NCT04431713
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University College, London
- Conditions
- Multiple System Atrophy
- Interventions
- Exenatide Pen Injector [Bydureon]
- First posted
- 2020-06-16
- Last updated
- 2025-06-27
- Other registries' IDs
- eudract:2020-000122-26
- Results first posted
- 2025-06-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in UMSARS Score (Parts I+II) From Baseline | Baseline and 48 weeks | The primary endpoint is the total Unified Multiple System Atrophy Rating Scale (UMSARS) score (Parts I and II), exploring the change from baseline overtime (evaluated at 48-weeks). Part I is a 12-item historical interview (max score 48) and Part II is a 14-item clinical examination (max score 56). Part I and II are added together to give a total score, which can range from 0 to 104. Higher scores indicate worse disease severity. |
| Secondary | Loss of Independent Ambulation | 48 weeks | Proportion of participants with loss of independent ambulation, defined by a score of 4 on the UMSARS-I Item 7 (walking) at 48 weeks. |
| Secondary | Multiple System Atrophy Quality of Life (MSA-QoL) Scale | 48 weeks | The Multiple System Atrophy Quality of Life (MSA-QoL) scale measured health-related quality of life across three subscales (motor, nonmotor, and emotional/social functioning). Each item (40 in total) has five increasing levels of impairment (0 to 4), with 0 representing no impairment and 4 representing extreme impairment. Scores for the three subscales were generated by summing items and transformed to a range of 0 to 100 (100 × \[(observed score minus min possible score)/(max possible score minus min possible score)\]). |
| Secondary | Number of Falls | 48 weeks | Number of falls reported by the participant at 48-weeks. |
| Secondary | Milestones on UMSARS Part 1 (Speech, Swallow and Falling) | 48 weeks | The UMSARS Part 1 is 12-item sub-scale which comprises a historic review of disease-related impairments. A single score using a 0 (no impairment) to 4 (severe impairment) was generated for each item (max score 48 points). We examined the proportion of participants reaching a score of ≥ 3 on UMSARS item 1 (speech), item 2 (swallowing) and item 8 (falling) by 48 weeks. |
| Secondary | Clinical Global Impression (CGI) Scale | 48 weeks | The CGI evaluates the change from the initiation of treatment on a seven-point scale (1 = =very much improved to 7 = very much worse since the initiation of treatment). A single score at 48 weeks was recorded. |
| Secondary | Montreal Cognitive Assessment (MoCA) | 48 weeks | The MoCA is a brief cognitive scale (scored out of 0-30 points). A score of 26 or more reflects normal cognitive abilities, whereas lower scores indicate cognitive impairment. The difference between groups (total score out of 30) was explored at 48 weeks. |
| Secondary | UMSARS Part IV | Score at 48 Weeks | The UMSARS Part 4 measures global disability (1 item) scored from 1 (completely independent) to 5 (totally dependent and helpless. Bedridden). |
| Secondary | Beck Depression Inventory II (BDI-II) | 48 weeks | The BDI-II is a self-report questionnaire designed to measure the severity of depression symptomatology (scored out of 0-63 points). A score of 13 or less indicated minimal, 14-19 indicated mild, 20-28 indicated moderate and 29-63 indicated severe depression. The difference between groups was explored at 48 weeks. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in UMSARS Score (Parts I+II) From Baseline | Baseline and 48 weeks | score on a scale | MEAN | |
| SECONDARY | Loss of Independent Ambulation | 48 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Multiple System Atrophy Quality of Life (MSA-QoL) Scale | 48 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Falls | 48 weeks | Number of falls | MEAN | |
| SECONDARY | Milestones on UMSARS Part 1 (Speech, Swallow and Falling) | 48 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Global Impression (CGI) Scale | 48 weeks | score on a scale | MEAN | |
| SECONDARY | Montreal Cognitive Assessment (MoCA) | 48 weeks | score on a scale | MEAN | |
| SECONDARY | UMSARS Part IV | Score at 48 Weeks | Score on a scale | MEAN | |
| SECONDARY | Beck Depression Inventory II (BDI-II) | 48 weeks | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in UMSARS Score (Parts I+II) From Baseline | Exenatide | 6.1 | 95% Confidence Interval 3.0 to 9.3 | score on a scale | |
| Change in UMSARS Score (Parts I+II) From Baseline | Standard of Care | 13.3 | 95% Confidence Interval 9.2 to 17.3 | score on a scale | |
| Loss of Independent Ambulation | Exenatide | 2 | Participants | ||
| Loss of Independent Ambulation | Standard of Care | 2 | Participants | ||
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Exenatide | MSA QoL (Motor Domain) | 53.1 | Standard Deviation 19.8 | score on a scale |
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Standard of Care | MSA QoL (Motor Domain) | 53.7 | Standard Deviation 23.7 | score on a scale |
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Exenatide | MSA QoL (Non-motor Domain) | 37.4 | Standard Deviation 17.8 | score on a scale |
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Standard of Care | MSA QoL (Non-motor Domain) | 39.3 | Standard Deviation 15.4 | score on a scale |
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Exenatide | MSA QoL (Emotional/Social Functioning Domain) | 33.3 | Standard Deviation 22.8 | score on a scale |
| Multiple System Atrophy Quality of Life (MSA-QoL) Scale | Standard of Care | MSA QoL (Emotional/Social Functioning Domain) | 43.1 | Standard Deviation 23.9 | score on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exenatide | 25 | |
| Overall Study | STARTED | Standard of Care | 25 | |
| Overall Study | COMPLETED | Exenatide | 21 | |
| Overall Study | COMPLETED | Standard of Care | 23 | |
| Overall Study | NOT COMPLETED | Exenatide | 4 | |
| Overall Study | NOT COMPLETED | Standard of Care | 2 |
Source ClinicalTrials.gov
Adverse events46
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 | Nausea | Gastrointestinal disorders | Exenatide | 6 | 25 | 9 |
| other | Nausea | Gastrointestinal disorders | Standard of Care | 1 | 25 | 1 |
| serious | Anxiety | Psychiatric disorders | Exenatide | 1 | 25 | |
| serious | Anxiety | Psychiatric disorders | Standard of Care | 0 | 25 | |
| serious | Aspiration | Respiratory, thoracic and mediastinal disorders | Exenatide | 2 | 25 | |
| serious | Aspiration | Respiratory, thoracic and mediastinal disorders | Standard of Care | 1 | 25 | |
| serious | Constipation | Gastrointestinal disorders | Exenatide | 1 | 25 | |
| serious | Constipation | Gastrointestinal disorders | Standard of Care | 0 | 25 | |
| serious | Dehydration | Metabolism and nutrition disorders | Exenatide | 0 | 25 | |
| serious | Dehydration | Metabolism and nutrition disorders | Standard of Care | 1 | 25 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exenatide | 2 | 25 |
| Total, all-cause mortality | Standard of Care | 2 | 25 |
| Total, other adverse events | Exenatide | 6 | 25 |
| Total, other adverse events | Standard of Care | 1 | 25 |
| Total, serious adverse events | Exenatide | 10 | 25 |
| Total, serious adverse events | Standard of Care | 10 | 25 |
Source ClinicalTrials.gov
Papers32
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exenatide vs Standard of Care: Loss of Independent Ambulation | Trial comparisons |
| Exenatide vs Standard of Care: deaths from any cause | Trial comparisons |
| Exenatide vs Standard of Care: serious adverse events | Trial comparisons |
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/NCT04431713
GET https://conductscience.org/api/trials/v1/NCT04431713/results?page=2