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COVID-19
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This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pridopidine Dose 1 | Experimental | Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period |
|
| Pridopidine Dose 2 | Experimental | Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period |
|
| Placebo | Placebo Comparator | Matching placebo (oral capsule) for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pridopidine | Drug | Oral capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score | Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical [Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)] and Objective [Part 3 (Impairment) and Part 4 (Disability)] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4. | Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Yael Cohen | Prilenia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prilenia Investigational Site (Site 117) | Birmingham | Alabama | 35233 | United States | ||
| Prilenia Investigational Site (Site 144) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31356217 | Derived | McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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A total of 23 patients were randomized to pridopidine 100 mg BID (n=7), pridopidine 150 mg BID (n=8), or placebo (n=8). Of these, 5 patients randomized to 150 mg BID discontinued study drug during the titration period prematurely (i.e. did not reach the maintenance dose) and were therefore analyzed in the 100 mg BID group.
The study was terminated early due to the COVID-19 pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pridopidine 100 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg 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 | Nov 19, 2019 | Apr 19, 2022 |
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| Placebo |
| Drug |
Oral capsule |
|
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Prilenia Investigational Site (Site 111) | Phoenix | Arizona | 85013 | United States |
| Prilenia Investigational Site (Site 115) | Scottsdale | Arizona | 85259 | United States |
| Prilenia Investigational Site (Site 106) | Fountain Valley | California | 92708 | United States |
| Prilenia Investigational Site (Site 109) | Irvine | California | 92697 | United States |
| Prilenia Investigational Site (Site 105) | Pasadena | California | 91105 | United States |
| Prilenia Investigational Site (Stie 142) | Torrance | California | 90502 | United States |
| Prilenia Investigational Site (Site 136) | Aurora | Colorado | 80045 | United States |
| Prilenia Investigational Site (Site 135) | Englewood | Colorado | 80113 | United States |
| Prilenia Investigational Site (Site 118) | Boca Raton | Florida | 33431 | United States |
| Prilenia Investigational Site (Site 131) | Maitland | Florida | 32751 | United States |
| Prilenia Investigational Site (Site 122) | Sunrise | Florida | 33351 | United States |
| Prilenia Investigational Site (Site 116) | Tampa | Florida | 33612 | United States |
| Prilenia Investigational Site (Site 138) | Atlanta | Georgia | 30329 | United States |
| Prilenia Investigational Site (Stie 123) | Augusta | Georgia | 30912 | United States |
| Prilenia Investigational Site (Site 107) | Iowa City | Iowa | 52242 | United States |
| Prilenia Investigational Site (Site 102) | Kansas City | Kansas | 66160 | United States |
| Prilenia Investigational Site (Site 126) | Omaha | Nebraska | 68198 | United States |
| Prilenia Investigational Site (Site 141) | New Brunswick | New Jersey | 08901 | United States |
| Prilenia Investigational Site (Site 128) | Amherst | New York | 14226 | United States |
| Prilenia Investigational Site (Site 147) | New York | New York | 10029 | United States |
| Prilenia Investigational Site (Site 101) | Raleigh | North Carolina | 27607 | United States |
| Prilenia Investigational Site (Site 127) | Raleigh | North Carolina | 27612 | United States |
| Prilenia Investigational Site (Site 149) | Dayton | Ohio | 45459 | United States |
| Prilenia Investigational Site (Site 139) | Tulsa | Oklahoma | 74136 | United States |
| Prilenia Investigational Site (Site 114) | Philadelphia | Pennsylvania | 19107 | United States |
| Prilenia Investigational Site (Site 146) | Willow Grove | Pennsylvania | 19090 | United States |
| Prilenia Investigational Site (Site 119) | Providence | Rhode Island | 02903 | United States |
| Prilenia Investigational Site (Site 120) | Houston | Texas | 77030 | United States |
| Prilenia Investigational Site (Site 121) | Houston | Texas | 77030 | United States |
| Prilenia Investigational Site (Site 129) | San Antonio | Texas | 78230 | United States |
| Prilenia Investigational Site (Site 103) | Kirkland | Washington | 98034 | United States |
| FG001 | Pridopidine 150 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID. |
| FG002 | Placebo | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo. |
| Treatment Group Based on Maximal Possible Highest Dose Received (Used for Analysis) | A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID. |
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| COMPLETED |
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| NOT COMPLETED |
|
|
A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pridopidine 100 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID. |
| BG001 | Pridopidine 150 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID. |
| BG002 | Placebo | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo. |
| BG003 | 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Levodopa-induced Dyskinesia as Measured by UDysRS Score | Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical [Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)] and Objective [Part 3 (Impairment) and Part 4 (Disability)] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4. | The primary endpoint was analyzed for the population of patients randomized and on study drug at Visit 5 (Week 8/10). Of the 3 pridopidine patients included, 1 and 2 patients, respectively, received pridopidine 100 and 150 mg. Analysis of these data, separately for each pridopidine dose, is not meaningful or conclusive. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit. |
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|
|
From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo.
A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
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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 100 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG001 | Pridopidine 150 mg BID | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Placebo | Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo. | 0 | 8 | 1 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug effect decreased | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Freezing phenomenon | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Vaginal odour | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
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The study was terminated early due to the COVID-19 pandemic.
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2020 | Apr 19, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| C483720 | pridopidine |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change from baseline at Visit 5 |
|