A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

NCT00665223, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2023-08-29

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease	ClinicalTrials.gov
NCT number	NCT00665223	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Phase 3	ClinicalTrials.gov
Enrollment	437 participants, actual	ClinicalTrials.gov
Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.	ClinicalTrials.gov
Conditions	Huntington's Disease	ClinicalTrials.gov
Interventions	ACR16, Placebo	ClinicalTrials.gov
First posted	2008-04-23	ClinicalTrials.gov
Last updated	2023-08-29	ClinicalTrials.gov
Results first posted	2023-08-29	ClinicalTrials.gov

Registered outcomes 8

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 Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26	Baseline, Week 26	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 include 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 are rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranges from 0 to 52, with higher scores indicating more severe motor impairment.	ClinicalTrials.gov
Secondary	The UHDRS Functional Assessment at Week 26	Week 26	The UHDRS Functional Assessment considers 25 items associated with functional problems. The participant scores 1 point for every item to which they respond positively (zero points for negative responses). Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability.	ClinicalTrials.gov
Secondary	Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Week 26	Global improvement is 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 at Week 26	Baseline, Week 26	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 at Week 26	Baseline, Week 26	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 at Week 26	Baseline, Week 26	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 to 42. Lower change from baseline scores indicate improvement.	ClinicalTrials.gov
Secondary	Randomized Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Baseline up to Week 30	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 AEs that began after ACR16/placebo administration through week 26 or up to week 30 for participants not continuing in the open-label period. AEs included both serious adverse events (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
Secondary	Open-label Phase: Number of Participants With TEAEs	Week 26 up to Week 56	An 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 through Week 56. 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 8

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 Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26	Baseline, Week 26	Full Analysis Set (FAS) included 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	The UHDRS Functional Assessment at Week 26	Week 26	FAS included 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 Clinical Global Impression - Improvement (CGI-I) Score	Week 26	FAS included 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 at Week 26	Baseline, Week 26	FAS included 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 at Week 26	Baseline, Week 26	FAS included 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 at Week 26	Baseline, Week 26	FAS included 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	Randomized Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Baseline up to Week 30	Safety analysis set included all randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov
SECONDARY	Open-label Phase: Number of Participants With TEAEs	Week 26 up to Week 56	Open-label analysis set (OLAS) included the subset of participants who completed the randomized phase on study treatment and who consented to enter the open-label follow-up phase.	Participants	COUNT_OF_PARTICIPANTS	ClinicalTrials.gov

Results by group 45

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 Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26	Placebo/ACR16 90 mg		0.27	Standard Deviation 4.43	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 Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26	ACR16 45 mg/90 mg		-0.23	Standard Deviation 4.12	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 Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26	ACR16 90 mg/90 mg		-0.94	Standard Deviation 3.87	units on a scale	ClinicalTrials.gov
The UHDRS Functional Assessment at Week 26	Placebo/ACR16 90 mg		16.81	Standard Deviation 6.20	Units on a Scale	ClinicalTrials.gov
The UHDRS Functional Assessment at Week 26	ACR16 45 mg/90 mg		17.50	Standard Deviation 5.73	Units on a Scale	ClinicalTrials.gov
The UHDRS Functional Assessment at Week 26	ACR16 90 mg/90 mg		17.48	Standard Deviation 5.43	Units on a Scale	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Placebo/ACR16 90 mg	Very much improved	1		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 45 mg/90 mg	Very much improved	1		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 90 mg/90 mg	Very much improved	1		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Placebo/ACR16 90 mg	Much improved	8		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 45 mg/90 mg	Much improved	8		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 90 mg/90 mg	Much improved	7		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Placebo/ACR16 90 mg	Minimally improved	30		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 45 mg/90 mg	Minimally improved	32		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 90 mg/90 mg	Minimally improved	33		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Placebo/ACR16 90 mg	No change	55		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 45 mg/90 mg	No change	59		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 90 mg/90 mg	No change	50		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	Placebo/ACR16 90 mg	Minimally worse	38		Participants	ClinicalTrials.gov
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score	ACR16 45 mg/90 mg	Minimally worse	37		Participants	ClinicalTrials.gov

Participant flow 21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Randomized Phase (26 Weeks)	STARTED	Placebo/ACR16 90 mg	144	ClinicalTrials.gov
Randomized Phase (26 Weeks)	STARTED	ACR16 45 mg/90 mg	148	ClinicalTrials.gov
Randomized Phase (26 Weeks)	STARTED	ACR16 90 mg/90 mg	145	ClinicalTrials.gov
Randomized Phase (26 Weeks)	Received at Least 1 Dose of Study Drug	Placebo/ACR16 90 mg	144	ClinicalTrials.gov
Randomized Phase (26 Weeks)	Received at Least 1 Dose of Study Drug	ACR16 45 mg/90 mg	148	ClinicalTrials.gov
Randomized Phase (26 Weeks)	Received at Least 1 Dose of Study Drug	ACR16 90 mg/90 mg	145	ClinicalTrials.gov
Randomized Phase (26 Weeks)	COMPLETED	Placebo/ACR16 90 mg	126	ClinicalTrials.gov
Randomized Phase (26 Weeks)	COMPLETED	ACR16 45 mg/90 mg	136	ClinicalTrials.gov
Randomized Phase (26 Weeks)	COMPLETED	ACR16 90 mg/90 mg	124	ClinicalTrials.gov
Randomized Phase (26 Weeks)	NOT COMPLETED	Placebo/ACR16 90 mg	18	ClinicalTrials.gov
Randomized Phase (26 Weeks)	NOT COMPLETED	ACR16 45 mg/90 mg	12	ClinicalTrials.gov
Randomized Phase (26 Weeks)	NOT COMPLETED	ACR16 90 mg/90 mg	21	ClinicalTrials.gov
Open-Label Period (26 Weeks)	STARTED	Placebo/ACR16 90 mg	113	ClinicalTrials.gov
Open-Label Period (26 Weeks)	STARTED	ACR16 45 mg/90 mg	125	ClinicalTrials.gov
Open-Label Period (26 Weeks)	STARTED	ACR16 90 mg/90 mg	115	ClinicalTrials.gov
Open-Label Period (26 Weeks)	COMPLETED	Placebo/ACR16 90 mg	97	ClinicalTrials.gov
Open-Label Period (26 Weeks)	COMPLETED	ACR16 45 mg/90 mg	108	ClinicalTrials.gov
Open-Label Period (26 Weeks)	COMPLETED	ACR16 90 mg/90 mg	100	ClinicalTrials.gov
Open-Label Period (26 Weeks)	NOT COMPLETED	Placebo/ACR16 90 mg	16	ClinicalTrials.gov
Open-Label Period (26 Weeks)	NOT COMPLETED	ACR16 45 mg/90 mg	17	ClinicalTrials.gov

Adverse events 335

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	HUNTINGTON'S CHOREA	Congenital, familial and genetic disorders	Randomized Phase: Placebo	9	144	10	ClinicalTrials.gov
other	HUNTINGTON'S CHOREA	Congenital, familial and genetic disorders	Randomized Phase: ACR16 45 mg	7	148	7	ClinicalTrials.gov
other	HUNTINGTON'S CHOREA	Congenital, familial and genetic disorders	Randomized Phase: ACR16 90 mg	10	145	10	ClinicalTrials.gov
other	HUNTINGTON'S CHOREA	Congenital, familial and genetic disorders	Open Label Phase: Placebo	7	113	7	ClinicalTrials.gov
other	HUNTINGTON'S CHOREA	Congenital, familial and genetic disorders	Open Label Phase: ACR 16	29	240	32	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	Randomized Phase: Placebo	7	144	8	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	Randomized Phase: ACR16 45 mg	10	148	11	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	Randomized Phase: ACR16 90 mg	9	145	10	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	Open Label Phase: Placebo	3	113	3	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	Open Label Phase: ACR 16	8	240	9	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	Randomized Phase: Placebo	9	144	13	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	Randomized Phase: ACR16 45 mg	9	148	11	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	Randomized Phase: ACR16 90 mg	5	145	5	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	Open Label Phase: Placebo	2	113	2	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	Open Label Phase: ACR 16	5	240	5	ClinicalTrials.gov
other	FATIGUE	General disorders	Randomized Phase: Placebo	9	144	10	ClinicalTrials.gov
other	FATIGUE	General disorders	Randomized Phase: ACR16 45 mg	7	148	8	ClinicalTrials.gov
other	FATIGUE	General disorders	Randomized Phase: ACR16 90 mg	4	145	5	ClinicalTrials.gov
other	FATIGUE	General disorders	Open Label Phase: Placebo	4	113	4	ClinicalTrials.gov
other	FATIGUE	General disorders	Open Label Phase: ACR 16	6	240	6	ClinicalTrials.gov

Adverse event totals 15

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Randomized Phase: Placebo			ClinicalTrials.gov
Total, all-cause mortality	Randomized Phase: ACR16 45 mg			ClinicalTrials.gov
Total, all-cause mortality	Randomized Phase: ACR16 90 mg			ClinicalTrials.gov
Total, all-cause mortality	Open Label Phase: Placebo			ClinicalTrials.gov
Total, all-cause mortality	Open Label Phase: ACR 16			ClinicalTrials.gov
Total, other adverse events	Randomized Phase: Placebo	54	144	ClinicalTrials.gov
Total, other adverse events	Randomized Phase: ACR16 45 mg	49	148	ClinicalTrials.gov
Total, other adverse events	Randomized Phase: ACR16 90 mg	56	145	ClinicalTrials.gov
Total, other adverse events	Open Label Phase: Placebo	38	113	ClinicalTrials.gov
Total, other adverse events	Open Label Phase: ACR 16	88	240	ClinicalTrials.gov
Total, serious adverse events	Randomized Phase: Placebo	11	144	ClinicalTrials.gov
Total, serious adverse events	Randomized Phase: ACR16 45 mg	10	148	ClinicalTrials.gov
Total, serious adverse events	Randomized Phase: ACR16 90 mg	9	145	ClinicalTrials.gov
Total, serious adverse events	Open Label Phase: Placebo	6	113	ClinicalTrials.gov
Total, serious adverse events	Open Label Phase: ACR 16	15	240	ClinicalTrials.gov

Papers 2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22071279	DERIVED	PubMed
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

The same record as JSON

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)