Trial · NCT03608371
BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations
NCT03608371, Phase 2, Completed, BlackThorn Therapeutics, Inc.; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations. Trials, record NCT03608371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03608371
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations
- NCT number
- NCT03608371
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- BlackThorn Therapeutics, Inc.
- Conditions
- Parkinson Disease, Motor Disorder
- Interventions
- BTRX-246040, Placebo
- First posted
- 2018-07-31
- Last updated
- 2025-06-24
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | From pre-dose to 8 hours post-dose on Day 1 | UPDRS = Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). The score ranges from 0-56. |
| Secondary | Duration of ON Time on Day 1 | From dose to 8 hours post-dose on Day 1 | ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications. |
| Secondary | Percentage of Participants Who Turned ON on Day 1 | From dose to 8 hours post-dose on Day 1 | ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications. |
| Secondary | Time to ON on Day 1 | From dose to 8 hours post-dose on Day 1 | ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications. |
| Secondary | Area Under the Curve for UPDRS Part III During the 8 Hours of Assessment on Day 1 | From pre-dose to 8 hours post-dose on Day 1 | The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). UDPRS Part III was assessed pre-dose and every 30 minutes for 4 hours and then hourly for another 4 hours (i.e., 8 hours following study drug administration) on Day 1. |
| Secondary | Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment) | From pre-dose to 8 hours post-dose on Day 1 | The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). An additional single item to rate dyskinesia was added to the UDPRS and was rated from 0 (no dyskinesia) to 4 (severe dyskinesia: maximal amplitude and present during most of the examinations). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | From pre-dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. | score on a scale | MEAN |
| SECONDARY | Duration of ON Time on Day 1 | From dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. 21 participants reached an ON status on Day 1; however, only 12 participants had a time recorded for when they reached OFF status on Day 1. Therefore, Duration of ON Time on Day 1 is only available for 12 participants. | hours | MEAN |
| SECONDARY | Percentage of Participants Who Turned ON on Day 1 | From dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to ON on Day 1 | From dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. 21 participants reached an ON status on Day 1. | hours | MEAN |
| SECONDARY | Area Under the Curve for UPDRS Part III During the 8 Hours of Assessment on Day 1 | From pre-dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. | score on a scale*minutes | MEAN |
| SECONDARY | Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment) | From pre-dose to 8 hours post-dose on Day 1 | Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | BTRX-246040 Cohort 1 | -22.0 | Standard Deviation 7.01 | score on a scale | |
| Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | BTRX-246040 Cohort 2 | -12.5 | Standard Deviation 4.68 | score on a scale | |
| Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | BTRX-246040 Cohort 3 | -11.2 | Standard Deviation 3.92 | score on a scale | |
| Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | Combined BTRX-246040 | -15.2 | Standard Deviation 7.08 | score on a scale | |
| Maximal Change in UPDRS Part III From Predose to Postdose on Day 1 | Placebo | -17.0 | Standard Deviation 12.07 | score on a scale | |
| Duration of ON Time on Day 1 | BTRX-246040 Cohort 1 | 2.983 | Standard Deviation 1.8144 | hours | |
| Duration of ON Time on Day 1 | BTRX-246040 Cohort 2 | 3.750 | Standard Deviation 1.8484 | hours | |
| Duration of ON Time on Day 1 | BTRX-246040 Cohort 3 | 4.000 | hours | ||
| Duration of ON Time on Day 1 | Combined BTRX-246040 | 3.494 | Standard Deviation 1.6095 | hours | |
| Duration of ON Time on Day 1 | Placebo | 4.250 | Standard Deviation 1.5000 | hours |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BTRX-246040 Cohort 1 | 6 | |
| Overall Study | STARTED | BTRX-246040 Cohort 2 | 6 | |
| Overall Study | STARTED | BTRX-246040 Cohort 3 | 6 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | BTRX-246040 Cohort 1 | 6 | |
| Overall Study | COMPLETED | BTRX-246040 Cohort 2 | 6 | |
| Overall Study | COMPLETED | BTRX-246040 Cohort 3 | 6 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | BTRX-246040 Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | BTRX-246040 Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
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 | Dry mouth | Gastrointestinal disorders | BTRX-246040 Cohort 1 | 1 | 6 | |
| other | Dry mouth | Gastrointestinal disorders | BTRX-246040 Cohort 2 | 0 | 6 | |
| other | Dry mouth | Gastrointestinal disorders | BTRX-246040 Cohort 3 | 0 | 6 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 6 | |
| other | Nausea | Gastrointestinal disorders | BTRX-246040 Cohort 1 | 0 | 6 | |
| other | Nausea | Gastrointestinal disorders | BTRX-246040 Cohort 2 | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | BTRX-246040 Cohort 3 | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 6 | |
| other | Chest pain | General disorders | BTRX-246040 Cohort 1 | 0 | 6 | |
| other | Chest pain | General disorders | BTRX-246040 Cohort 2 | 0 | 6 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BTRX-246040 Cohort 1 | 0 | 6 |
| Total, all-cause mortality | BTRX-246040 Cohort 2 | 0 | 6 |
| Total, all-cause mortality | BTRX-246040 Cohort 3 | 0 | 6 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | BTRX-246040 Cohort 1 | 1 | 6 |
| Total, other adverse events | BTRX-246040 Cohort 2 | 2 | 6 |
| Total, other adverse events | BTRX-246040 Cohort 3 | 3 | 6 |
| Total, other adverse events | Placebo | 1 | 6 |
| Total, serious adverse events | BTRX-246040 Cohort 1 | 0 | 6 |
| Total, serious adverse events | BTRX-246040 Cohort 2 | 0 | 6 |
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/NCT03608371
GET https://conductscience.org/api/trials/v1/NCT03608371/results?page=2