A Study of Treatment With Pridopidine (ACR16) in Particip... | NCT00665223 | Trialant
NCT00665223
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Status
Completed
Last Update Posted
Aug 29, 2023Actual
Enrollment
437Actual
Phase
Phase 3
Conditions
Huntington's Disease
Interventions
ACR16
Placebo
Countries
Austria
Belgium
France
Germany
Italy
Portugal
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00665223
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACR16 C008
Secondary IDs
Not provided
Brief Title
A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease
Official Title
A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.
Detailed Description
The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder. To achieve this, participants are randomized to ACR16 45 mg once daily, ACR16 45 mg twice daily, or placebo treatment in equal proportions in a parallel design for a treatment duration of 26 weeks.
Conditions Module
Conditions
Huntington's Disease
Keywords
Huntington's Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
437Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses.
Drug: Placebo
ACR16 45 mg
Experimental
Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses.
Drug: ACR16
Drug: Placebo
ACR16 90 mg
Experimental
Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg)
Drug: ACR16
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACR16
Drug
Capsules will be swallowed whole with water.
ACR16 45 mg
ACR16 90 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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.
Baseline, Week 26
Secondary Outcomes
Measure
Description
Time Frame
The UHDRS Functional Assessment at 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.
Week 26
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able to provide written Informed Consent prior to any study related procedure.
Huntington's disease diagnosed with the aid of clinical features and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene.
Male or female age ≥ 30 years.
Willing and able to take oral medication and able to comply with the study specific procedures.
Ambulatory, being able to travel to the assessment centre, and judged by the Investigator as likely to be able to continue to travel for the duration of the study.
Availability of a caregiver or family member to accompany the participant.
A sum of ≥ 10 points on the mMS at the screening visit.
For participants taking allowed antipsychotic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization. The allowed antipsychotic medication is Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.
For participants taking allowed antidepressant or other psychotropic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization.
Willing to provide a blood sample for CAG analysis (where CAG result is not already available).
In France only, the participant must be affiliated to a social security system or be a beneficiary of such a system.
Exclusion Criteria:
Unable to give written informed consent.
Treatment with any non-allowed antipsychotic medication within 12 weeks of randomization. The non-allowed antipsychotic medication is any medication other than Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.
Treatment with the antidepressants Fluoxetine or Paroxetine within 6 weeks of randomization.
Use of Tetrabenazine within 12 weeks of randomization, or at any time during the study period.
Treatment with any investigational product within 4 weeks of randomization.
Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6 inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of randomization.
Participants previously included into this study.
A prolonged QTc interval at screen (defined as a QTc interval of > 450 milliseconds [msec] for males or > 470 msec for females), or other clinically significant heart conditions.
Creatinine clearance <40 milliliters (mL)/minute (min) as measured at the screening visit.
Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the participants' suitability for the study or puts the participant at risk if he/she enters the study.
Clinically significant hepatic or renal impairment.
Participants with a history of epilepsy or a history of seizure(s) of unknown cause.
Severe intercurrent illness, which, in the opinion of the Investigator, may put the participant at risk when participating in the trial or may influence the results of the trial or affect the participants' ability to take part in the trial.
Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual - Fourth Edition - Text Revision (DSM IV-TR) criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
Participants with suicidal ideation, defined as a positive score on criteria for major depressive episode, item A9 on the DSM-IV-TR criteria for a Major Depressive Episode.
Females who are pregnant or lactating.
Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
Known allergy to any ingredients of the trial medication or placebo.
Any previous participation in a clinical study with ACR16.
Participants currently receiving deep brain stimulation.
Participants with a history of surgical procedures aiming to improve the symptoms of Huntington's disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents or previous attempts of deep brain stimulation.
Darpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.
de Yebenes JG, Landwehrmeyer B, Squitieri F, Reilmann R, Rosser A, Barker RA, Saft C, Magnet MK, Sword A, Rembratt A, Tedroff J; MermaiHD study investigators. Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Dec;10(12):1049-57. doi: 10.1016/S1474-4422(11)70233-2. Epub 2011 Nov 7.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants that completed the randomized phase to week 26 on-treatment were given the option to continue treatment in the open-label phase.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 milligrams (mg) capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
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.
Week 26
Change From Baseline in Stroop Word Reading Test at 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.
Baseline, Week 26
Change From Baseline in Total UHDRS Behavioral Assessment Score at 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.
Baseline, Week 26
Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score at 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.
Baseline, Week 26
Randomized Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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'.
Baseline up to Week 30
Open-label Phase: Number of Participants With TEAEs
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'.
Week 26 up to Week 56
Innsbruck
Tyrol
A-6020
Austria
University Hospital Gasthuisberg
Leuven
Flemish Brabant
3000
Belgium
CHU Roger Salengro
Lille
Hauts-de-France
59037
France
Hôpital Purpan, Place Docteur-Baylac, Bâtiment F
Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria
Milan
Lombardy
20133
Italy
IRCCS Neuromed, Localita Camarelle
Pozzilli
Molise
86077
Italy
University Hospital of Coimbra, Av. Rissaya Barreto
Coimbra
Baixo Mondego
3000-075
Portugal
Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz
Lisbon
1649-028
Portugal
Hospital Mútua de Terrassa, C/ Castell
Terrassa
Catalonia
08225
Spain
Hospital Clinic of Barcelona, Calle Villarroel, 170
Barcelona
08036
Spain
Hospital Ramon y Cajal, Carretera Colemenar km 9.100
Madrid
28034
Spain
Hospital Universitario La Fe, Avda. Campanar 21,
Valencia
46009
Spain
R&D Headquarters, Barberry Centre, 25 Vincent Drive
Birmingham
England/West Midlands
B15 2SG
United Kingdom
Department of Clinical Genetics, St Mary's Hospital, Hathersage Road
Manchester
North West England
M13 9WL
United Kingdom
First Floor Argyll House, Fosterhill, Cornhill Road
Aberdeen
Scotland
AB25 2ZR
United Kingdom
SE Scotland Genetic Service, Western General Hospital, Crewe Road
Edinburgh
Scotland
EH4 2XU
United Kingdom
Churchill Hospital, Old Road, Headington
Oxford
South East England
OX3 7LJ
United Kingdom
Academic Neurology Unit, E Floor Medical School Beech Hill Road
Sheffield
South Yorkshire
S10 2RX
United Kingdom
Institute of Human Genetics, Centre for Life, Central Parkway
Newcastle upon Tyne
Tyne and Wear
NE1 3BZ
United Kingdom
Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park
Cardiff
Wales
CF14 4XN
United Kingdom
Cambridge Centre for Brain repair, Cambridge University
Cambridge
CB2 2PY
United Kingdom
FG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
FG002
ACR16 90 mg/90 mg
Randomized Phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
FG000144 subjects
FG001148 subjects
FG002145 subjects
Received at Least 1 Dose of Study Drug
FG000144 subjects
FG001148 subjects
FG002145 subjects
COMPLETED
FG000126 subjects
FG001136 subjects
FG002124 subjects
NOT COMPLETED
FG00018 subjects
FG00112 subjects
FG00221 subjects
Type
Comment
Reasons
Adverse Event
FG00013 subjects
FG0019 subjects
FG00215 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG0005 subjects
FG0012 subjects
FG0023 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0021 subjects
Other than specified
FG0000 subjects
FG0010 subjects
FG0021 subjects
Open-Label Period (26 Weeks)
Type
Comment
Milestone Data
STARTED
FG000113 subjects
FG001125 subjects
FG002115 subjects
COMPLETED
FG00097 subjects
FG001108 subjects
FG002100 subjects
NOT COMPLETED
FG00016 subjects
FG00117 subjects
FG00215 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG00111 subjects
FG0027 subjects
Death
FG000
Full analysis set included all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo/ACR16 90 mg
Randomized-phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
BG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
BG002
ACR16 90 mg/90 mg
Randomized Phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000144
BG001148
BG002145
BG003437
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.1± 9.6
BG00151.0± 10.7
BG00251.8± 11.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00076
BG00182
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG0000
BG0012
BG002
Unified Huntington's Disease Rating Scale (UHDRS) Modified Motor Score (mMS)
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.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00019.43± 8.28
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Units
Counts
Participants
OG000138
OG001146
OG002139
Title
Denominators
Categories
Title
Measurements
OG0000.27± 4.43
OG001-0.23± 4.12
OG002-0.94± 3.87
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.
ANCOVA
0.456
Mean Difference (Final Values)
-0.36
2-Sided
97.5
-1.44
0.72
Superiority
This analysis compared ACR16 45 mg vs. placebo during the randomization phase.
Secondary
The UHDRS Functional Assessment at 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.
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.
Posted
Mean
Standard Deviation
Units on a Scale
Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Secondary
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
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.
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.
Posted
Count of Participants
Participants
Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Secondary
Change From Baseline in Stroop Word Reading Test at 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.
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.
Posted
Mean
Standard Deviation
correct responses
Baseline, Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Secondary
Change From Baseline in Total UHDRS Behavioral Assessment Score at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG001
Secondary
Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 26
ID
Title
Description
OG000
Placebo/ACR16 90 mg
Randomized phase: Participants received a placebo capsule matched to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule was taken twice daily as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Secondary
Randomized Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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'.
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline up to Week 30
ID
Title
Description
OG000
Randomized Phase: Placebo
Participants received placebo matched to ACR16 in the randomized phase.
OG001
Randomized Phase: ACR16 45 mg
Participants received ACR16 45 mg in the randomized phase.
OG002
Randomized Phase: ACR16 90 mg
Participants received ACR16 90 mg in the randomized phase.
Secondary
Open-label Phase: Number of Participants With TEAEs
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'.
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.
Posted
Count of Participants
Participants
Week 26 up to Week 56
ID
Title
Description
OG000
Open-label Phase: Placebo/ACR16 90 mg
Participants who received placebo during the randomized phase received ACR16 90 mg in the open-label phase.
OG001
Open-label Phase: ACR16 45 mg/90 mg
Participants who received ACR16 45 mg during the randomized phase received ACR16 90 mg in the open-label phase.
OG002
Open-label Phase: ACR16 90 mg/90 mg
Participants who received ACR16 90 mg during the randomized phase continued to receive ACR16 90 mg in the open-label phase.
Time Frame
Baseline up to Week 56
Description
Safety set included all randomized participants who received at least 1 dose of study drug. The Open-label analysis set included participants who completed the randomized phase (RP) and entered the open-label phase (OLP). AEs were analyzed in the OLP for participants who received ACR16 in the RP and then received ACR16 90 mg in the OLP as one group combined per planned analysis. Participants who received placebo in the RP and received ACR16 90 mg in OLP were analyzed as a separate OL group.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Randomized Phase: Placebo
Participants received placebo matched to ACR16 in the randomized phase.
11
144
54
144
EG001
Randomized Phase: ACR16 45 mg
Participants received ACR16 45 mg in the randomized phase.
10
148
49
148
EG002
Randomized Phase: ACR16 90 mg
Participants received ACR16 90 mg in the randomized phase.
9
145
56
145
EG003
Open Label Phase: Placebo
Participants who received placebo during the randomized phase and received ACR16 90 mg in the open label phase.
6
113
38
113
EG004
Open Label Phase: ACR 16
Participants who received ACR16 45 mg or 90 mg in the randomized phase and received ACR16 90 mg in the open label phase.
15
240
88
240
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAL SPASM
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG0030 events0 affected113 at risk
EG0040 events0 affected240 at risk
CONSTIPATION
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ASTHENIA
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ABSCESS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ALCOHOL POISONING
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
RESPIRATORY FUME INHALATION DISORDER
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0022 events1 affected145 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
OVARIAN EPITHELIAL CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
AGGRESSION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
COMPLETED SUICIDE
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected144 at risk
EG0010 events0 affected148 at risk
EG0022 events2 affected145 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
CHOKING
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
PNEUMONIA ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected145 at risk
EG003
NEURODERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected145 at risk
EG003
HUNTINGTON'S CHOREA
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
CHEST PAIN
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
CHOLANGITIS
Hepatobiliary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
HELICOBACTER GASTRITIS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
INTENTIONAL OVERDOSE
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
LOWER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
OVERDOSE
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
GLASGOW COMA SCALE ABNORMAL
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
DUPUYTREN'S CONTRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
MALIGNANT MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ABNORMAL BEHAVIOUR
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
MAJOR DEPRESSION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
PSYCHOTIC DISORDER
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
ENTROPION
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected144 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected145 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HUNTINGTON'S CHOREA
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG00010 events9 affected144 at risk
EG0017 events7 affected148 at risk
EG00210 events10 affected145 at risk
EG0037 events7 affected113 at risk
EG004
DIARRHOEA
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0008 events7 affected144 at risk
EG00111 events10 affected148 at risk
EG00210 events9 affected145 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00013 events9 affected144 at risk
EG00111 events9 affected148 at risk
EG0025 events5 affected145 at risk
EG003
FATIGUE
General disorders
MedDRA 11.0
Systematic Assessment
EG00010 events9 affected144 at risk
EG0018 events7 affected148 at risk
EG0025 events4 affected145 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0006 events6 affected144 at risk
EG00111 events9 affected148 at risk
EG00210 events10 affected145 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00017 events12 affected144 at risk
EG00110 events7 affected148 at risk
EG00219 events15 affected145 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0006 events6 affected144 at risk
EG00110 events10 affected148 at risk
EG00218 events8 affected145 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0005 events4 affected144 at risk
EG0014 events4 affected148 at risk
EG0028 events8 affected145 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0008 events8 affected144 at risk
EG0016 events6 affected148 at risk
EG0026 events6 affected145 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0005 events5 affected144 at risk
EG0015 events5 affected148 at risk
EG00211 events9 affected145 at risk
EG003
IRRITABILITY
General disorders
MedDRA 11.0
Systematic Assessment
EG0006 events6 affected144 at risk
EG0013 events3 affected148 at risk
EG0026 events6 affected145 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor has the right 30 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Point of Contact
Title
Organization
Phone
Extension
Email
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
1-888-483-8279
USMedInfo@tevapharm.com
ID
Term
D006816
Huntington Disease
Ancestor Terms
ID
Term
D001480
Basal Ganglia Diseases
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D003704
Dementia
D002819
Chorea
D020820
Dyskinesias
D009069
Movement Disorders
D020271
Heredodegenerative Disorders, Nervous System
D019636
Neurodegenerative Diseases
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003072
Cognition Disorders
D019965
Neurocognitive Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C483720
pridopidine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0022 subjects
Withdrawal by Subject
FG0005 subjects
FG0013 subjects
FG0024 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
Other than specified
FG0000 subjects
FG0010 subjects
FG0022 subjects
50.6
± 10.5
64
BG003222
Male
BG00068
BG00166
BG00281
BG003215
0
BG0032
Other
BG0000
BG0011
BG0020
BG0031
Caucasian
BG000144
BG001145
BG002145
BG003434
18.38
± 6.76
BG00218.57± 6.90
BG00318.79± 7.34
OG000
OG002
The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.
ANCOVA
0.042
Mean Difference (Final Values)
-0.99
2-Sided
97.5
-2.08
0.10
Superiority
This analysis compared ACR16 90 mg vs. placebo during the randomization phase.
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Units
Counts
Participants
OG000139
OG001146
OG002139
Title
Denominators
Categories
Title
Measurements
OG00016.81± 6.20
OG00117.50± 5.73
OG00217.48± 5.43
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Units
Counts
Participants
OG000139
OG001146
OG002140
Title
Denominators
Categories
Title
Measurements
Very much improved
OG0001
OG0011
OG0021
Much improved
OG0008
OG0018
OG0027
Minimally improved
OG00030
OG00132
OG00233
No change
OG00055
OG00159
OG00250
Minimally worse
OG00038
OG00137
OG00246
Much worse
OG0007
OG0019
OG0022
Very much worse
OG0000
OG0010
OG0020
Missing
OG0000
OG0010
OG0021
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Units
Counts
Participants
OG000135
OG001140
OG002136
Title
Denominators
Categories
Title
Measurements
OG000-1.3± 11.9
OG001-1.1± 10.3
OG002-0.8± 11.7
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Units
Counts
Participants
OG000139
OG001146
OG002139
Title
Denominators
Categories
Title
Measurements
OG0000.12± 13.51
OG001-0.41± 16.78
OG002-2.22± 10.84
OG001
ACR16 45 mg/90 mg
Randomized phase: Participants received ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule were taken as 2 separate doses.
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
OG002
ACR16 90 mg/90 mg
Randomized phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).
Open-label phase: Participants received ACR16 45 mg capsule once daily for the first 4 weeks (Weeks 26 to 30). After 4 weeks (Weeks 31 to 52), ACR16 45 mg capsule was taken twice daily as 2 separate doses (total dose: 90 mg).