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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000904-24 | EudraCT Number |
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This study served its purpose in providing considerable safety data.
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The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pridopidine | Experimental | The mode of administration is oral. Capsules will be swallowed whole with water. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose. Study drug can be taken irrespective of meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pridopidine | Drug | 45 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | From signature of the informed consent form through the end of the study, which was defined as Week 106 | 106 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening. | Week 52; end of treatment (EOT) which was planned to occur at Week 104 |
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Inclusion Criteria:
Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
Women of child bearing potential or male participants: Adequate contraception and birth control
Good general health
Exclusion Criteria:
Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
Similar concomitant medication restrictions to PRIDE HD.
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Pharmaceuticals USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 12204 | Los Angeles | California | 90095 | United States | ||
| Teva Investigational Site 12201 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30572891 | Derived | Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pridopidine 45 mg BID | Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2016 | Jul 27, 2021 |
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| Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening. | Week 52; end of treatment (EOT) which was planned to occur at Week 104 |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Teva Investigational Site 12196 | Washington D.C. | District of Columbia | 20007 | United States |
| Teva Investigational Site 12206 | Baltimore | Maryland | 21287 | United States |
| Teva Investigational Site 12200 | Manhasset | New York | 11030 | United States |
| Teva Investigational Site 12203 | New York | New York | 10032 | United States |
| Teva Investigational Site 12198 | Rochester | New York | 14618 | United States |
| Teva Investigational Site 12211 | Winston-Salem | North Carolina | 27157 | United States |
| Teva Investigational Site 12209 | Pittsburgh | Pennsylvania | 15213 | United States |
| Teva Investigational Site 12208 | Salt Lake City | Utah | 84108 | United States |
| Teva Investigational Site 12210 | Richmond | Virginia | 23230 | United States |
| Teva Investigational Site 78055 | Caulfield South | 3162 | Australia |
| Teva Investigational Site 78058 | West Perth | 6005 | Australia |
| Teva Investigational Site 78057 | Westmead | 2145 | Australia |
| Teva Investigational Site 33021 | Innsbruck | A-6020 | Austria |
| Teva Investigational Site 33027 | Vienna | 1010 | Austria |
| Teva Investigational Site 11036 | Toronto | Ontario | M3B 2S7 | Canada |
| Teva Investigational Site 35123 | Angers | 49933 | France |
| Teva Investigational Site 35122 | Créteil | 94010 | France |
| Teva Investigational Site 35125 | Lille | 59037 | France |
| Teva Investigational Site 35124 | Marseille | 13385 | France |
| Teva Investigational Site 35121 | Salouël | 80054 | France |
| Teva Investigational Site 35165 | Toulouse | 31059 | France |
| Teva Investigational Site 32408 | Berlin | 10117 | Germany |
| Teva Investigational Site 32410 | Bochum | 44791 | Germany |
| Teva Investigational Site 32409 | Münster | 48149 | Germany |
| Teva Investigational Site 32407 | Ulm | 89081 | Germany |
| Teva Investigational Site 30083 | Florence | 50134 | Italy |
| Teva Investigational Site 30080 | Milan | 20133 | Italy |
| Teva Investigational Site 30082 | Naples | 80131 | Italy |
| Teva Investigational Site 30081 | San Giovanni Rotondo | 71013 | Italy |
| Teva Investigational Site 38059 | Leiden | 2333 ZA | Netherlands |
| Teva Investigational Site 53150 | Gdansk | 80-462 | Poland |
| Teva Investigational Site 53149 | Krakow | 31-505 | Poland |
| Teva Investigational Site 53148 | Poznan | 60-529 | Poland |
| Teva Investigational Site 53151 | Warsaw | 02-957 | Poland |
| Teva Investigational Site 50215 | Kazan' | 420101 | Russia |
| Teva Investigational Site 50213 | Moscow | 125367 | Russia |
| Teva Investigational Site 50214 | Nyznij Novgorod | 603126 | Russia |
| Teva Investigational Site 34058 | Birmingham | B15 2SG | United Kingdom |
| Teva Investigational Site 34054 | Cambridge | CB2 2PY | United Kingdom |
| Teva Investigational Site 34059 | Cardiff | CF14 4XN | United Kingdom |
| Teva Investigational Site 34055 | Manchester | M13 9WL | United Kingdom |
| Teva Investigational Site 34061 | Newcastle upon Tyne | NE6 4QD | United Kingdom |
| Teva Investigational Site 34056 | Oxford | OX3 9DU | United Kingdom |
| Teva Investigational Site 34057 | Sheffield | S10 2JF | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Pridopidine 45 mg BID | Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid) |
| 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 (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| CYP2D6 metaboliser genotype | Count of Participants | Participants |
| |||||||||||||||||||||||
| Neuroleptic use | Count of Participants | Participants |
| |||||||||||||||||||||||
| Number of CAG repeats | Mean | Standard Deviation | 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 | Percentage of Participants With Adverse Events | From signature of the informed consent form through the end of the study, which was defined as Week 106 | All patients enrolled who received at least one dose of study drug | Posted | Count of Participants | Participants | 106 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening. | All patients enrolled who received at least 1 dose of study drug and had at least 1 post-baseline UHDRS-TMS assessment. | Posted | Mean | Standard Deviation | second | Week 52; end of treatment (EOT) which was planned to occur at Week 104 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening. | All patients enrolled who received at least 1 dose of study drug and had at least 1 post-baseline UHDRS-TMS assessment. | Posted | Mean | Standard Deviation | percentage | Week 52; end of treatment (EOT) which was planned to occur at Week 104 |
|
|
From signature of the informed consent form through the end of the study, which was defined as Week 106
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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 | Pridopidine 45 mg BID | Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid) | 3 | 248 | 31 | 248 | 191 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Toxicity to varios agents | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Huntington's disease | Congenital, familial and genetic disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chorea | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Peripheral nerve palsy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal polyp haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 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 |
| |
| Chorea | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
This was an open-label extension of study TV7820-CNS-20002. It was terminated on 10 Nov 2017, as it was considered by the sponsor to have served its purpose in providing long-term safety data. Study termination was not based on safety concerns.
Data and results are owned by the sponsor. Results can be used by the institution for internal noncommercial research, education and patient care, and 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2018 | Jul 27, 2021 | SAP_001.pdf |
| 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
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| ID | Term |
|---|---|
| C483720 | pridopidine |
Not provided
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Netherlands |
|
| United States |
|
| Poland |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Australia |
|
| Germany |
|
| Russia |
|
| Intermediate metaboliser |
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| Ultra-rapid metaboliser |
|
|
|