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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001888-23 | EudraCT Number |
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| Name | Class |
|---|---|
| European Huntington's Disease Network | NETWORK |
| Huntington Study Group | NETWORK |
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This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).
Originally, the study was designed to assess the effect of pridopidine on motor function at 26 weeks. Due to the recognition that the primary target of pridopidine is the Sigma-1 receptor, the trial was extended from 26 to 52 weeks to evaluate the effect of pridopidine on Total Functional Capacity (TFC). A minimum of 52 weeks are needed for the placebo group to decline and allow a window to assess an effect on TFC (a prespecified endpoint). Approximately 20% of patients completed 26 weeks of the study before IRB approvals for this extension, and did not continue into the 2nd treatment period up to 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pridopidine 45 mg | Experimental | Twice daily |
|
| Pridopidine 67.5 mg | Experimental | Twice daily |
|
| Pridopidine 90 mg | Experimental | Twice daily |
|
| Pridopidine 112.5 mg | Experimental | Twice daily |
|
| Placebo | Placebo Comparator | Twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pridopidine | Drug | 22.5 mg and 45 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Functional Capacity (TFC) at Week 52 | The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening. |
Inclusion Criteria:
Diagnosis of HD based on the presence of >/= 36 CAG repeats
Male or female age ≥21 years, with an onset of HD after 18 years' old.
Females of childbearing potential must be compliant in using adequate birth control throughout the duration of the study
Body weight ≥50 kg
Sum of >= 25 points on the UHDRS-TMS and UHDRS Independence Score <=90%
Able and willing to provide written informed consent prior to any study related procedure.
Willing to provide a blood sample for genetic analyses
Willing and able to take oral medication and able to comply with the study specific procedures.
Ambulatory, being able to travel to the study center, and judged by the investigator as likely to be able to continue to travel for the duration of the study.
Availability and willingness of a caregiver, informant or family member to accompany the patient to the clinic at study, and the suitability of the caregiver should be judged by the Investigator.
Exclusion Criteria:
Patients with clinically significant heart disease at the screening visit
Treatment with tetrabenazine within 6 weeks of study screening
Patients with a history of epilepsy or of seizures within the last 5 years
Have other serious medical illnesses in the opinion of the investigator may put the patient at risk when participating in the study or may influence the results of the study or affect the patient's ability to take part in the study
Patients receiving medications (within the last 6 weeks prior to screening) that have been proven to prolong QT interval or who may require such medications during the course of the study such as but not limited to non allowed anti psychotic medications, tricyclic antidepressants and/or Class I antiarrhythmics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 12199 | La Jolla | California | United States | |||
| Investigational Site 12204 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33164941 | Background | McGarry A, Leinonen M, Kieburtz K, Geva M, Olanow CW, Hayden M. Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study. J Huntingtons Dis. 2020;9(4):371-380. doi: 10.3233/JHD-200440. | |
| 36811812 | Derived | 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. |
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A total of 492 patients were screened; of these, 408 were randomized. The main reason for not randomizing patients was noncompliance with the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Pridopidine matching placebo (hard capsules) Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to the randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Through Week 26) |
|
Not provided
Not provided
Not provided
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Not provided
|
| Placebo | Other | Capsules matching drug |
|
| 52 weeks |
| Los Angeles |
| California |
| United States |
| Investigational Site 12201 | Englewood | Colorado | United States |
| Investigational Site 12196 | Washington D.C. | District of Columbia | United States |
| Investigational Site 12207 | Chicago | Illinois | United States |
| Investigational Site 12202 | Baltimore | Maryland | United States |
| Investigational Site 12206 | Baltimore | Maryland | United States |
| Investigational Site 12200 | Manhasset | New York | United States |
| Investigational Site 12203 | New York | New York | United States |
| Investigational Site 12198 | Rochester | New York | United States |
| Investigational Site 12211 | Winston-Salem | North Carolina | United States |
| Investigational Site 12205 | Cincinnati | Ohio | United States |
| Investigational Site 12209 | Pittsburgh | Pennsylvania | United States |
| Investigational Site 12208 | Salt Lake City | Utah | United States |
| Investigational Site 12210 | Richmond | Virginia | United States |
| Investigational Site 12197 | Kirkland | Washington | United States |
| Investigational Site 78055 | Caulfield South | Australia |
| Investigational Site 78056 | Kew | Australia |
| Investigational Site 78058 | Subiaco | Australia |
| Investigational Site 78057 | Westmead | Australia |
| Investigational Site 33021 | Innsbruck | Austria |
| Investigational Site 33027 | Vienna | Austria |
| Investigational Site 11035 | Vancouver | British Columbia | Canada |
| Investigational Site 11037 | Ottawa | Ontario | Canada |
| Investigational Site 11036 | Toronto | Ontario | Canada |
| Investigational Site 39028 | Aarhus | Denmark |
| Investigational Site 39027 | Copenhagen | Denmark |
| Investigational Site 35123 | Angers | France |
| Investigational Site 35122 | Créteil | France |
| Investigational Site 35125 | Lille | France |
| Investigational Site 35124 | Marseille | France |
| Investigational Site 35121 | Salouël | France |
| Investigational Site 35165 | Toulouse | France |
| Investigational Site 32408 | Berlin | Germany |
| Investigational Site 32410 | Bochum | Germany |
| Investigational Site 32409 | Münster | Germany |
| Investigational Site 32407 | Ulm | Germany |
| Investigational Site 30083 | Florence | Italy |
| Investigational Site 30080 | Milan | Italy |
| Investigational Site 30082 | Naples | Italy |
| Investigational Site 30081 | Pozzilli | Italy |
| Investigational Site 30084 | San Giovanni Rotondo | Italy |
| Investigational Site 38059 | Leiden | Netherlands |
| Investigational Site 53150 | Gdansk | Poland |
| Investigational Site 53149 | Krakow | Poland |
| Investigational Site 53148 | Poznan | Poland |
| Investigational Site 53151 | Warsaw | Poland |
| Investigational Site 50215 | Kazan' | Russia |
| Investigational Site 50213 | Moscow | Russia |
| Investigational Site 50214 | Nizhny Novgorod | Russia |
| Investigational Site 34058 | Birmingham | United Kingdom |
| Investigational Site 34054 | Cambridge | United Kingdom |
| Investigational Site 34059 | Cardiff | United Kingdom |
| Investigational Site 34056 | Headington | United Kingdom |
| Investigational Site 34060 | London | United Kingdom |
| Investigational Site 34055 | Manchester | United Kingdom |
| Investigational Site 34061 | Newcastle upon Tyne | United Kingdom |
| Investigational Site 34057 | Sheffield | United Kingdom |
| 30776019 | Derived | Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001. |
| 30563778 | Derived | Reilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15. |
| Pridopidine 45 mg BID |
Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| FG002 | Pridopidine 67.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| FG003 | Pridopidine 90 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| FG004 | Pridopidine 112.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| ITT | Intention-to-treat: patients randomised into the study and dispensed study drug. |
|
| FAS | Full analysis set: patients from the ITT who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. The FAS included efficacy observations measured up to Week 52. |
|
| Safety Set | Including all patients who took at least 1 dose of study drug. The analysis set included safety observations measured up to Week 52. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 (Through Week 52) |
|
|
Intent-to-treat: all patients randomized into the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Pridopidine matching placebo (hard capsules) Patients received a starting dose of placebo matching pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| BG001 | Pridopidine 45 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| BG002 | Pridopidine 67.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| BG003 | Pridopidine 90 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| BG004 | Pridopidine 112.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Use of neuroleptics | Count of Participants | Participants |
| ||||||||||||||||
| CYP2D6 genotype | Count of Participants | Participants |
| ||||||||||||||||
| Number of Cytosine-Adenosine-Guanine (CAG) Repeats | Mean | Standard Deviation | Number of CAG repeats |
|
| 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 Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement. | Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Error | score on a scale | 26 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events | Safety Analysis set, i.e. patients who received at least one dose of study drug | Posted | Count of Participants | Participants | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Total Functional Capacity (TFC) at Week 52 | The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening. | Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Least Squares Mean | Standard Error | score on a scale | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change in Total Functional Capacity (TFC) From Baseline in Patients With Early HD (Defined as Patients With TFC>=7) | The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening. | FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | Posted | Least Squares Mean | Standard Error | score on a scale | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Total Functional Capacity Responder Rate in Early HD | The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Responder was defined as a TFC change to Week 52 of TFC>=0. | FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7 who completed 52 weeks. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | Posted | Count of Participants | Participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Tap-interval-MN-Hand, Early HD | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Tap-interval-MN-Hand, measured in seconds. Positive change from baseline indicates worsening. | FAS i.e. pts receiving >=1 dose of study drug and with >=1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3. | Posted | Least Squares Mean | Standard Error | seconds | 26 and 52 weeks |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Pridopidine matching placebo (hard capsules) Patients received a starting dose of pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26. | 0 | 82 | 0 | 82 | 45 | 82 |
| EG001 | Pridopidine 45 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26. | 0 | 81 | 8 | 81 | 49 | 81 |
| EG002 | Pridopidine 67.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26. | 0 | 82 | 9 | 82 | 63 | 82 |
| EG003 | Pridopidine 90 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26. | 1 | 81 | 9 | 81 | 57 | 81 |
| EG004 | Pridopidine 112.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26. | 1 | 82 | 9 | 82 | 53 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Adenocarcinoma of the colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mood disorder due to a general medical condition | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tetention | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chorea | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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Analyses for Early HD population were conducted as additional analyses
Data and results are owned by the sponsor. Results can be used by the institution for (a) internal noncommercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prilenia | Prilenia | +972 775558 | 482 | info@prilenia.com |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C483720 | pridopidine |
Not provided
Not provided
Not provided
| Noncompliance |
|
| Adverse Event |
|
| Other |
|
| Not treated |
|
| Withdrawal by Subject |
|
| Sponsor decision |
|
| Male |
|
| Black |
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| Asian |
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| Other |
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| Missing |
|
| No |
|
| Extensive metaboliser |
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| Intermediate metaboliser |
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| Ultra-rapid metaboliser |
|
| LSM difference |
| 1.7 |
| 2-Sided |
| 95 |
| -1.06 |
| 4.46 |
| Superiority |
| Mixed Models Analysis | 0.6348 | LSM difference | 0.66 | 2-Sided | 95 | -2.07 | 3.39 | Superiority |
| Mixed Models Analysis | 0.1447 | LSM difference | 2.04 | 2-Sided | 95 | -0.71 | 4.8 | Superiority |
| OG003 | Pridopidine 90 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| OG004 | Pridopidine 112.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 52. |
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| OG002 | Pridopidine 67.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| OG003 | Pridopidine 90 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
| OG004 | Pridopidine 112.5 mg BID | Pridopidine given as hard capsules, twice daily Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52. |
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Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
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