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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03922711
• Date of registration: 17/04/2019
• Prospective Registration: No
• Primary sponsor: Prilenia
• Public title: 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
• Scientific 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)
• Date of first enrolment: March 26, 2019
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03922711
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Yael Cohen
• Affiliation: Prilenia

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: Pridopidine

Primary Outcome(s)

Change in levodopa-induced dyskinesia [Time Frame: Baseline and Week 16]

Secondary ID(s)

PL101-LID201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors