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 Phase 2 study testing Pridopidine in people with Parkinson Disease, run by Prilenia at 33 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 85 years
Conditions the study is for: Parkinson Disease
What is being tested?: Pridopidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 33 sitesUnited States
Study dates: 22 May 2019to 22 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

Prilenia Investigational Site (Site 128)
Amherst, New York, 14226
Prilenia Investigational Site (Site 138)
Atlanta, Georgia, 30329
Prilenia Investigational Site (Stie 123)
Augusta, Georgia, 30912
Prilenia Investigational Site (Site 136)
Aurora, Colorado, 80045
Prilenia Investigational Site (Site 117)
Birmingham, Alabama, 35233
Prilenia Investigational Site (Site 118)
Boca Raton, Florida, 33431
Prilenia Investigational Site (Site 149)
Dayton, Ohio, 45459
Prilenia Investigational Site (Site 135)
Englewood, Colorado, 80113
Prilenia Investigational Site (Site 106)
Fountain Valley, California, 92708
Prilenia Investigational Site (Site 120)
Houston, Texas, 77030
Prilenia Investigational Site (Site 121)
Houston, Texas, 77030
Prilenia Investigational Site (Site 107)
Iowa City, Iowa, 52242
Prilenia Investigational Site (Site 109)
Irvine, California, 92697
Prilenia Investigational Site (Site 102)
Kansas City, Kansas, 66160
Prilenia Investigational Site (Site 103)
Kirkland, Washington, 98034
Prilenia Investigational Site (Site 131)
Maitland, Florida, 32751
Prilenia Investigational Site (Site 141)
New Brunswick, New Jersey, 08901
Prilenia Investigational Site (Site 147)
New York, New York, 10029
Prilenia Investigational Site (Site 126)
Omaha, Nebraska, 68198
Prilenia Investigational Site (Site 105)
Pasadena, California, 91105
Prilenia Investigational Site (Site 114)
Philadelphia, Pennsylvania, 19107
Prilenia Investigational Site (Site 144)
Phoenix, Arizona, 85004
Prilenia Investigational Site (Site 111)
Phoenix, Arizona, 85013
Prilenia Investigational Site (Site 119)
Providence, Rhode Island, 02903
Prilenia Investigational Site (Site 101)
Raleigh, North Carolina, 27607
Prilenia Investigational Site (Site 127)
Raleigh, North Carolina, 27612
Prilenia Investigational Site (Site 129)
San Antonio, Texas, 78230
Prilenia Investigational Site (Site 115)
Scottsdale, Arizona, 85259
Prilenia Investigational Site (Site 122)
Sunrise, Florida, 33351
Prilenia Investigational Site (Site 116)
Tampa, Florida, 33612
Prilenia Investigational Site (Stie 142)
Torrance, California, 90502
Prilenia Investigational Site (Site 139)
Tulsa, Oklahoma, 74136
Prilenia Investigational Site (Site 146)
Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

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)

Conditions: Parkinson Disease
Being tested: Pridopidine, Placebo
Keywords: Levodopa, Dyskinesia
Medical subject headings: Parkinson Disease, Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PridopidineDrug
Oral capsule
PlaceboDrug
Oral capsule

Study groups in NCT03922711
Study group	Role	What they receive
Pridopidine Dose 1	Experimental	Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period Receives: Drug: Pridopidine; Drug: Placebo
Pridopidine Dose 2	Experimental	Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period Receives: Drug: Pridopidine
Placebo	Placebo comparator	Matching placebo (oral capsule) for 16 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201922 Jul 2020

First posted22 Apr 2019
Study start22 May 2019
Primary completion22 Jul 2020
Study completion22 Jul 2020

Why it stopped: COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03922711
Sponsor's protocol ID: PL101-LID201
Status last verified: Apr 2022
First submitted: 17 Apr 2019
Last updated: 1 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31356217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03922711
Acronym / sponsor ID: PL101-LID201
Conditions: Parkinson Disease
Keywords: Levodopa, Dyskinesia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19
Enrolment: 23 participants (actual)
Lead sponsor: PrileniaIndustry (pharma, biotech, devices)
Study start: 22 May 2019 (actual)
Primary completion: 22 Jul 2020 (actual)
Study completion: 22 Jul 2020 (actual)
First posted: 22 Apr 2019 (actual)
Results: Posted 1 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Pridopidine Dose 1	Experimental	Drug: Pridopidine, Drug: PlaceboDose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Pridopidine Dose 2	Experimental	Drug: PridopidineDose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Placebo	Placebo comparator	Drug: PlaceboMatching placebo (oral capsule) for 16 weeks

Who may qualify

Ages: 30 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PridopidineOral capsule	Drug	Pridopidine Dose 1, Pridopidine Dose 2
PlaceboOral capsule	Drug	Placebo, Pridopidine Dose 1

Primary outcome

Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
Time frame: 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.
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.

Results and safety

Results posted to the registry on 1 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pridopidine 100 mg BID	7	3
Pridopidine 150 mg BID	8	3
Placebo	8	4

Primary outcome: Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score

Time frame: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Pridopidine Total n = 3	Placebo n = 7
Baseline	32.0 (10.44)	35.9 (6.44)
Visit 5	14.7 (5.13)	26.1 (11.02)
Change from baseline at Visit 5	-17.3 (6.03)	-9.7 (9.43)

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pridopidine 100 mg BID	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Pridopidine 150 mg BID	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Placebo	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8

Limitations and caveats (from the sponsor): The study was terminated early due to the COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31356217McFarthing 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.
FDA Safety Alerts and RecallsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yael Cohen study director

Prilenia

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pridopidine in people with Parkinson Disease, run by Prilenia at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03922711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.