Trial · NCT01306929
Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
NCT01306929, Phase 2, Completed, Prilenia; results first posted 2022-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease. Trials, record NCT01306929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
- NCT number
- NCT01306929
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- Prilenia
- Conditions
- Huntington Disease
- Interventions
- pridopidine
- First posted
- 2011-03-02
- Last updated
- 2022-02-09
- Results first posted
- 2022-02-09
- Limitations and caveats
- The study was stopped at Sponsor discretion/request; last patient last visit was 5 Jan 2018.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With at Least One Adverse Event | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years | |
| Secondary | Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Baseline and at Month 12, 24, 36, 48, 60, and 72 | 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 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With at Least One Adverse Event | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years | Safety analysis set, including all enrolled patients who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Baseline and at Month 12, 24, 36, 48, 60, and 72 | Full analysis set, comprising all enrolled patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline UHDRS-TMS assessment. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With at Least One Adverse Event | Pridopidine | 119 | Participants | ||
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Baseline | 38.3 | Standard Deviation 15.2 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 12 | 41.5 | Standard Deviation 18.7 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 24 | 41.7 | Standard Deviation 20.7 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 36 | 44.7 | Standard Deviation 19.8 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 48 | 45.3 | Standard Deviation 19.7 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 60 | 45.7 | Standard Deviation 20.6 | score on a scale |
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | Pridopidine | Month 72 | 50.0 | Standard Deviation 23.2 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pridopidine | 134 | |
| Overall Study | COMPLETED | Pridopidine | 40 | |
| Overall Study | NOT COMPLETED | Pridopidine | 94 |
Source ClinicalTrials.gov
Adverse events390
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 | Anaemia | Blood and lymphatic system disorders | Pridopidine | 6 | 134 | 6 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Pridopidine | 1 | 134 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Pridopidine | 1 | 134 | 1 |
| other | Palpitations | Cardiac disorders | Pridopidine | 2 | 134 | 2 |
| other | Tachycardia | Cardiac disorders | Pridopidine | 2 | 134 | 2 |
| other | Aortic valve incompetence | Cardiac disorders | Pridopidine | 1 | 134 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Pridopidine | 1 | 134 | 2 |
| other | Bradycardia | Cardiac disorders | Pridopidine | 1 | 134 | 1 |
| other | Bundle branch block right | Cardiac disorders | Pridopidine | 1 | 134 | 1 |
| other | Cardiac failure congestive | Cardiac disorders | Pridopidine | 1 | 134 | 1 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pridopidine | 8 | 134 |
| Total, other adverse events | Pridopidine | 119 | 134 |
| Total, serious adverse events | Pridopidine | 31 | 134 |
Source ClinicalTrials.gov
Papers2
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 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/NCT01306929
GET https://conductscience.org/api/trials/v1/NCT01306929/events?page=2