A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease
NCT00724048, Phase 2, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2023-08-31
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease | ClinicalTrials.gov |
| NCT number | NCT00724048 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 227 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. | ClinicalTrials.gov |
| Conditions | Huntington Disease | ClinicalTrials.gov |
| Interventions | ACR16, Placebo | ClinicalTrials.gov |
| First posted | 2008-07-29 | ClinicalTrials.gov |
| Last updated | 2023-08-31 | ClinicalTrials.gov |
| Results first posted | 2023-08-31 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | Baseline, Week 12 | The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS included dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items were rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranged from 0 to 52, with higher scores indicating more severe motor impairment. The last observation carried forward (LOCF) method was used to generate an mMS score for each participant for Week 12 assessment. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Total Motor Score (TMS) | Basline, Week 12 | The UHDRS Motor Assessment comprises 31 responses from the 15 items, where each response is rated on a 5-point scale from 0 (normal) to 4 (maximally abnormal). The Total Motor Score (TMS) is the sum of all the 31 responses with higher scores indicating more severe motor impairment than lower scores. | ClinicalTrials.gov |
| Secondary | Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | Week 12 | The CGI-C was rated by the investigator on a 7-point scale as: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Stroop Word Reading Test | Baseline, Week 12 | The Stroop test measures the ability to concentrate and ward off distractions. The test consists of three items: (i) colour naming; (ii) word reading; (iii) interference. The word reading test requires participants to read colour words written in black and each response is scored as the number of correct answers made in 45 seconds. Higher scores indicate less severe disease, and an increase in score represents an improvement. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Total UHDRS Behavioral Assessment Score | Baseline, Week 12 | The total behavioral assessment score is the sum of the 11 products (depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations) of frequency and severity symptom scores and excluded the 3 yes/no questions relating to confusion, dementia, and depression. Frequency is rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity is rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment), with higher scores indicating greater behavioral impairments. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 12 | HADS is a self-administered instrument reliable for detecting states of depression and anxiety. It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale is comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale where higher scores indicate greater severity of anxiety and depression symptoms. The total HADS score was a composite score summed of all 14 items for a total range of 0-42. Lower change from baseline scores indicate improvement. | ClinicalTrials.gov |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 14 | An adverse event (AE) was defined as any change from the participant's baseline (pre-treatment) condition, other than improvement, that did not necessarily have causal relationship with the study drug. TEAEs were defined as adverse events that began after ACR16/placebo administration. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | ClinicalTrials.gov |
Outcomes 7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | Baseline, Week 12 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Total Motor Score (TMS) | Basline, Week 12 | The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | Week 12 | The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Stroop Word Reading Test | Baseline, Week 12 | The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Total UHDRS Behavioral Assessment Score | Baseline, Week 12 | The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score | Baseline, Week 12 | The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | Placebo | -1.40 | Standard Deviation 3.72 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | ACR16 10 mg BID | -1.30 | Standard Deviation 3.33 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | ACR16 22.5 mg BID | -2.49 | Standard Deviation 3.37 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12 | ACR16 45 mg BID | -2.32 | Standard Deviation 3.72 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Total Motor Score (TMS) | Placebo | -2.09 | Standard Deviation 8.31 | Units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Total Motor Score (TMS) | ACR16 10 mg BID | -1.92 | Standard Deviation 6.07 | Units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Total Motor Score (TMS) | ACR16 22.5 mg BID | -3.30 | Standard Deviation 6.91 | Units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Total Motor Score (TMS) | ACR16 45 mg BID | -4.61 | Standard Deviation 7.21 | Units on a scale | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | Placebo | Not assessed | 0 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 10 mg BID | Not assessed | 1 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 22.5 mg BID | Not assessed | 1 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 45 mg BID | Not assessed | 2 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | Placebo | Very much improved | 0 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 10 mg BID | Very much improved | 1 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 22.5 mg BID | Very much improved | 2 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 45 mg BID | Very much improved | 4 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | Placebo | Much improved | 8 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 10 mg BID | Much improved | 3 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 22.5 mg BID | Much improved | 8 | Participants | ClinicalTrials.gov | |
| Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale | ACR16 45 mg BID | Much improved | 4 | Participants | ClinicalTrials.gov |
Participant flow 20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 58 | ClinicalTrials.gov | |
| Overall Study | STARTED | ACR16 10 mg BID | 56 | ClinicalTrials.gov | |
| Overall Study | STARTED | ACR16 22.5 mg BID | 55 | ClinicalTrials.gov | |
| Overall Study | STARTED | ACR16 45 mg BID | 58 | ClinicalTrials.gov | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 58 | ClinicalTrials.gov | |
| Overall Study | Received at Least 1 Dose of Study Drug | ACR16 10 mg BID | 56 | ClinicalTrials.gov | |
| Overall Study | Received at Least 1 Dose of Study Drug | ACR16 22.5 mg BID | 55 | ClinicalTrials.gov | |
| Overall Study | Received at Least 1 Dose of Study Drug | ACR16 45 mg BID | 58 | ClinicalTrials.gov | |
| Overall Study | Full Analysis Set | Placebo | 58 | ClinicalTrials.gov | |
| Overall Study | Full Analysis Set | ACR16 10 mg BID | 55 | ClinicalTrials.gov | |
| Overall Study | Full Analysis Set | ACR16 22.5 mg BID | 55 | ClinicalTrials.gov | |
| Overall Study | Full Analysis Set | ACR16 45 mg BID | 58 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 55 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | ACR16 10 mg BID | 51 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | ACR16 22.5 mg BID | 52 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | ACR16 45 mg BID | 55 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 3 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | ACR16 10 mg BID | 5 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | ACR16 22.5 mg BID | 3 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | ACR16 45 mg BID | 3 | ClinicalTrials.gov |
Adverse events 80
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 | Source |
|---|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 58 | 3 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | ACR16 10mg BID | 3 | 56 | 4 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | ACR16 22.5 mg BID | 4 | 55 | 6 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | ACR16 45 mg BID | 2 | 58 | 2 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 58 | 0 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | ACR16 10mg BID | 1 | 56 | 1 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | ACR16 22.5 mg BID | 2 | 55 | 2 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | ACR16 45 mg BID | 3 | 58 | 3 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 58 | 5 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | ACR16 10mg BID | 2 | 56 | 2 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | ACR16 22.5 mg BID | 1 | 55 | 1 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | ACR16 45 mg BID | 5 | 58 | 5 | ClinicalTrials.gov |
| other | Fatigue | General disorders | Placebo | 5 | 58 | 6 | ClinicalTrials.gov |
| other | Fatigue | General disorders | ACR16 10mg BID | 1 | 56 | 1 | ClinicalTrials.gov |
| other | Fatigue | General disorders | ACR16 22.5 mg BID | 2 | 55 | 2 | ClinicalTrials.gov |
| other | Fatigue | General disorders | ACR16 45 mg BID | 2 | 58 | 2 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 58 | 1 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | ACR16 10mg BID | 2 | 56 | 2 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | ACR16 22.5 mg BID | 2 | 55 | 2 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | ACR16 45 mg BID | 3 | 58 | 3 | ClinicalTrials.gov |
Adverse event totals 12
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, all-cause mortality | ACR16 10mg BID | ClinicalTrials.gov | ||
| Total, all-cause mortality | ACR16 22.5 mg BID | ClinicalTrials.gov | ||
| Total, all-cause mortality | ACR16 45 mg BID | ClinicalTrials.gov | ||
| Total, other adverse events | Placebo | 22 | 58 | ClinicalTrials.gov |
| Total, other adverse events | ACR16 10mg BID | 18 | 56 | ClinicalTrials.gov |
| Total, other adverse events | ACR16 22.5 mg BID | 16 | 55 | ClinicalTrials.gov |
| Total, other adverse events | ACR16 45 mg BID | 30 | 58 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 1 | 58 | ClinicalTrials.gov |
| Total, serious adverse events | ACR16 10mg BID | 0 | 56 | ClinicalTrials.gov |
| Total, serious adverse events | ACR16 22.5 mg BID | 2 | 55 | ClinicalTrials.gov |
| Total, serious adverse events | ACR16 45 mg BID | 3 | 58 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 36811812 | DERIVED | PubMed |
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)