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出境医 / 临床实验 / A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Pridopidine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
Actual Study Start Date : March 26, 2019
Actual Primary Completion Date : July 22, 2020
Actual Study Completion Date : July 22, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 4 week dosage regimen titration period
 Drug: Pridopidine
Oral capsule

Drug: Placebo
Oral capsule
Experimental: Pridopidine Dose 2
Dose 2 for (oral capsule) for 12 weeks following 4 week dosage regimen titration period
 Drug: Pridopidine
Oral capsule
Placebo Comparator: Placebo
Matching placebo (oral capsule) for 16 weeks
 Drug: Placebo
Oral capsule
Outcome Measures
Primary Outcome Measures :
  1. Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 16 ]
    Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides signed informed consent form.
  • Has clinical diagnosis of Parkinson's Disease (PD).
  • Has Levodopa-induced dyskinesia (LID).
  • Patient and/or study partner must demonstrate ability to keep accurate home diary of PD symptoms.
  • Has stable anti-PD treatments for at least 28 days prior to start of study treatment and kept constant throughout study.
  • All routine and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must be at stable dosage for at least 28 days prior to start of study treatment and maintained throughout study.

Exclusion Criteria:

  • Diagnosis of atypical Parkinsonism.
  • Treatment with dopamine blocking drugs.
  • History of surgical intervention related to PD, such as deep brain stimulation.
  • History of severe depression, psychosis or hallucinations within 6 months prior to screening; active suicidal ideation; or suicidal attempt within 5 years prior to screening.
  • History of certain cancers within 5 years prior to screening.
  • Significant cardiac event within 12 weeks prior to Baseline or history of certain cardiac arrhythmias.
  • History of epilepsy or seizures within 5 years prior to screening.
  • Females who are pregnant or breastfeeding.
  • Sexually active female patients who are not surgically sterile or at least 2 years postmenopausal prior to screening, and who do not agree to utilize a highly effective hormonal method of contraception in combination with a barrier method, from screening until at least 4 weeks after completion of study treatment.
  • Male patients not using highly effective contraception or not agreeing to continue highly effective contraception until at least 90 days after the completion of study treatment.
  • Treatment with any investigational product within 30 days of screening or plans to participate in another clinical study assessing any investigational product during the study.

Other protocol-defined inclusion/exclusion criteria could apply.

Contacts and Locations

Locations
Show Show 33 study locations
Sponsors and Collaborators
Prilenia
Investigators
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Study Director: Yael Cohen Prilenia
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE March 26, 2019
Actual Primary Completion Date July 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020) 		Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 16 ]
Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 14 ]
Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease
Official Title  ICMJE A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Pridopidine
    Oral capsule
  • Drug: Placebo
    Oral capsule
Study Arms  ICMJE
  • Experimental: Pridopidine Dose 1
    Dose 1 (oral capsule) for 12 weeks following 4 week dosage regimen titration period
    Interventions:
    • Drug: Pridopidine
    • Drug: Placebo
  • Experimental: Pridopidine Dose 2
    Dose 2 for (oral capsule) for 12 weeks following 4 week dosage regimen titration period
    Intervention: Drug: Pridopidine
  • Placebo Comparator: Placebo
    Matching placebo (oral capsule) for 16 weeks
    Intervention: Drug: Placebo
Publications * McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2020) 		23
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		135
Actual Study Completion Date  ICMJE July 22, 2020
Actual Primary Completion Date July 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provides signed informed consent form.
  • Has clinical diagnosis of Parkinson's Disease (PD).
  • Has Levodopa-induced dyskinesia (LID).
  • Patient and/or study partner must demonstrate ability to keep accurate home diary of PD symptoms.
  • Has stable anti-PD treatments for at least 28 days prior to start of study treatment and kept constant throughout study.
  • All routine and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must be at stable dosage for at least 28 days prior to start of study treatment and maintained throughout study.

Exclusion Criteria:

  • Diagnosis of atypical Parkinsonism.
  • Treatment with dopamine blocking drugs.
  • History of surgical intervention related to PD, such as deep brain stimulation.
  • History of severe depression, psychosis or hallucinations within 6 months prior to screening; active suicidal ideation; or suicidal attempt within 5 years prior to screening.
  • History of certain cancers within 5 years prior to screening.
  • Significant cardiac event within 12 weeks prior to Baseline or history of certain cardiac arrhythmias.
  • History of epilepsy or seizures within 5 years prior to screening.
  • Females who are pregnant or breastfeeding.
  • Sexually active female patients who are not surgically sterile or at least 2 years postmenopausal prior to screening, and who do not agree to utilize a highly effective hormonal method of contraception in combination with a barrier method, from screening until at least 4 weeks after completion of study treatment.
  • Male patients not using highly effective contraception or not agreeing to continue highly effective contraception until at least 90 days after the completion of study treatment.
  • Treatment with any investigational product within 30 days of screening or plans to participate in another clinical study assessing any investigational product during the study.

Other protocol-defined inclusion/exclusion criteria could apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922711
Other Study ID Numbers  ICMJE PL101-LID201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prilenia
Study Sponsor  ICMJE Prilenia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yael Cohen Prilenia
PRS Account Prilenia
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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