Trial · NCT02006472
A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
NCT02006472, Phase 2, Completed, Prilenia; results first posted 2021-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease. Trials, record NCT02006472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
- NCT number
- NCT02006472
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 408 participants, actual
- Lead sponsor
- Prilenia
- Conditions
- Huntington's Disease
- Interventions
- Pridopidine, Placebo
- First posted
- 2013-12-10
- Last updated
- 2021-07-19
- Other registries' IDs
- eudract:2013-001888-23
- Results first posted
- 2021-07-19
- Limitations and caveats
- Analyses for Early HD population were conducted as additional analyses
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | 26 weeks | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement. |
| Secondary | Number of Patients With Adverse Events | 52 weeks | |
| Other | Change From Baseline in Total Functional Capacity (TFC) at Week 52 | 52 weeks | The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening. |
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 | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | 26 weeks | Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | Number of Patients With Adverse Events | 52 weeks | Safety Analysis set, i.e. patients who received at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline in Total Functional Capacity (TFC) at Week 52 | 52 weeks | Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | score on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Change in Total Functional Capacity (TFC) From Baseline in Patients With Early HD (Defined as Patients With TFC>=7) | 52 weeks | FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7.~The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | score on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Total Functional Capacity Responder Rate in Early HD | 52 weeks | FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7 who completed 52 weeks.~The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Tap-interval-MN-Hand, Early HD | 26 and 52 weeks | FAS i.e. pts receiving \>=1 dose of study drug and with \>=1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7.~The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | seconds | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | Placebo | -4.79 | Standard Error 0.99 | score on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | Pridopidine 45 mg BID | -3.37 | Standard Error 1.05 | score on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | Pridopidine 67.5 mg BID | -3.09 | Standard Error 1.02 | score on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | Pridopidine 90 mg BID | -4.13 | Standard Error 1.00 | score on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | Pridopidine 112.5 mg BID | -2.74 | Standard Error 1.01 | score on a scale | |
| Number of Patients With Adverse Events | Placebo | 62 | Participants | ||
| Number of Patients With Adverse Events | Pridopidine 45 mg BID | 63 | Participants | ||
| Number of Patients With Adverse Events | Pridopidine 67.5 mg BID | 69 | Participants | ||
| Number of Patients With Adverse Events | Pridopidine 90 mg BID | 71 | Participants | ||
| Number of Patients With Adverse Events | Pridopidine 112.5 mg BID | 67 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Through Week 26) | STARTED | Placebo | 82 | |
| Period 1 (Through Week 26) | STARTED | Pridopidine 45 mg BID | 81 | |
| Period 1 (Through Week 26) | STARTED | Pridopidine 67.5 mg BID | 82 | |
| Period 1 (Through Week 26) | STARTED | Pridopidine 90 mg BID | 81 | |
| Period 1 (Through Week 26) | STARTED | Pridopidine 112.5 mg BID | 82 | |
| Period 1 (Through Week 26) | ITT | Placebo | 82 | |
| Period 1 (Through Week 26) | ITT | Pridopidine 45 mg BID | 81 | |
| Period 1 (Through Week 26) | ITT | Pridopidine 67.5 mg BID | 82 | |
| Period 1 (Through Week 26) | ITT | Pridopidine 90 mg BID | 81 | |
| Period 1 (Through Week 26) | ITT | Pridopidine 112.5 mg BID | 82 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events310
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 | Hypertension | Vascular disorders | Placebo | 1 | 82 | 1 |
| other | Hypertension | Vascular disorders | Pridopidine 45 mg BID | 0 | 81 | 0 |
| other | Hypertension | Vascular disorders | Pridopidine 67.5 mg BID | 1 | 82 | 1 |
| other | Hypertension | Vascular disorders | Pridopidine 90 mg BID | 5 | 81 | 6 |
| other | Hypertension | Vascular disorders | Pridopidine 112.5 mg BID | 2 | 82 | 2 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 17 | 82 | 31 |
| other | Fall | Injury, poisoning and procedural complications | Pridopidine 45 mg BID | 16 | 81 | 44 |
| other | Fall | Injury, poisoning and procedural complications | Pridopidine 67.5 mg BID | 21 | 82 | 31 |
| other | Fall | Injury, poisoning and procedural complications | Pridopidine 90 mg BID | 13 | 81 | 19 |
| other | Fall | Injury, poisoning and procedural complications | Pridopidine 112.5 mg BID | 16 | 82 | 42 |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 82 |
| Total, all-cause mortality | Pridopidine 45 mg BID | 0 | 81 |
| Total, all-cause mortality | Pridopidine 67.5 mg BID | 0 | 82 |
| Total, all-cause mortality | Pridopidine 90 mg BID | 1 | 81 |
| Total, all-cause mortality | Pridopidine 112.5 mg BID | 1 | 82 |
| Total, other adverse events | Placebo | 45 | 82 |
| Total, other adverse events | Pridopidine 45 mg BID | 49 | 81 |
| Total, other adverse events | Pridopidine 67.5 mg BID | 63 | 82 |
| Total, other adverse events | Pridopidine 90 mg BID | 57 | 81 |
| Total, other adverse events | Pridopidine 112.5 mg BID | 53 | 82 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pridopidine 45 mg BID vs Placebo: Total Functional Capacity Responder Rate in Early HD |
Source 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/NCT02006472
GET https://conductscience.org/api/trials/v1/NCT02006472/results?page=2