Huntington's DiseasePhase 2Open PRIDE-HDNCT02494778

A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease

A Phase 2 study testing Pridopidine in people with Huntington's Disease, run by Prilenia at 46 sites in 11 countries.

Terminated

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

Trial summary

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). Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Huntington's Disease
What is being tested?: Pridopidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 46 sitesin 11 countries
Study dates: 24 Sep 2015to 12 Jan 2018
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
other criteria apply, please contact the investigator for more information

Who cannot join

Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
Similar concomitant medication restrictions to PRIDE HD.
other criteria apply, please contact the investigator for more information

Trial locations and contacts

46 sites in 11 countries.

Country

City, postcode or hospital

46 sites in 11 countries

United States11 sites

Teva Investigational Site 12206
Baltimore, Maryland, 21287
Teva Investigational Site 12201
Englewood, Colorado, 80113
Teva Investigational Site 12204
Los Angeles, California, 90095
Teva Investigational Site 12200
Manhasset, New York, 11030
Teva Investigational Site 12203
New York, New York, 10032
Teva Investigational Site 12209
Pittsburgh, Pennsylvania, 15213
Teva Investigational Site 12210
Richmond, Virginia, 23230
Teva Investigational Site 12198
Rochester, New York, 14618
Teva Investigational Site 12208
Salt Lake City, Utah, 84108
Teva Investigational Site 12196
Washington D.C., District of Columbia, 20007
Teva Investigational Site 12211
Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom7 sites

Teva Investigational Site 34058
Birmingham, B15 2SG
Teva Investigational Site 34054
Cambridge, CB2 2PY
Teva Investigational Site 34059
Cardiff, CF14 4XN
Teva Investigational Site 34055
Manchester, M13 9WL
Teva Investigational Site 34061
Newcastle upon Tyne, NE6 4QD
Teva Investigational Site 34056
Oxford, OX3 9DU
Teva Investigational Site 34057
Sheffield, S10 2JF

Other trials in United Kingdom

France6 sites

Teva Investigational Site 35123
Angers, 49933
Teva Investigational Site 35122
Créteil, 94010
Teva Investigational Site 35125
Lille, 59037
Teva Investigational Site 35124
Marseille, 13385
Teva Investigational Site 35121
Salouël, 80054
Teva Investigational Site 35165
Toulouse, 31059

Other trials in France

Germany4 sites

Teva Investigational Site 32408
Berlin, 10117
Teva Investigational Site 32410
Bochum, 44791
Teva Investigational Site 32409
Münster, 48149
Teva Investigational Site 32407
Ulm, 89081

Other trials in Germany

Italy4 sites

Teva Investigational Site 30083
Florence, 50134
Teva Investigational Site 30080
Milan, 20133
Teva Investigational Site 30082
Naples, 80131
Teva Investigational Site 30081
San Giovanni Rotondo, 71013

Other trials in Italy

Poland4 sites

Teva Investigational Site 53150
Gdansk, 80-462
Teva Investigational Site 53149
Krakow, 31-505
Teva Investigational Site 53148
Poznan, 60-529
Teva Investigational Site 53151
Warsaw, 02-957

Other trials in Poland

Australia3 sites

Teva Investigational Site 78055
Caulfield South, 3162
Teva Investigational Site 78058
West Perth, 6005
Teva Investigational Site 78057
Westmead, 2145

Other trials in Australia

Russia3 sites

Teva Investigational Site 50215
Kazan', 420101
Teva Investigational Site 50213
Moscow, 125367
Teva Investigational Site 50214
Nyznij Novgorod, 603126

Other trials in Russia

Austria2 sites

Teva Investigational Site 33021
Innsbruck, A-6020
Teva Investigational Site 33027
Vienna, 1010

Other trials in Austria

Canada1 site

Teva Investigational Site 11036
Toronto, Ontario, M3B 2S7

Other trials in Canada

Netherlands1 site

Teva Investigational Site 38059
Leiden, 2333 ZA

Other trials in Netherlands

About this study

Official title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

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).

Conditions: Huntington's Disease
Being tested: Pridopidine
Keywords: Huntington's disease, pridopidine
Medical subject headings: Huntington Disease

What participants receive

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

PridopidineDrug
Also called TV7820
45 mg BID

Study groups in NCT02494778
Study group	Role	What they receive
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. Receives: Drug: Pridopidine

What is being measured

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

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
Measured: 106 weeks

Secondary outcomes (2)

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.
Measured: Week 52; end of treatment (EOT) which was planned to occur at Week 104
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.
Measured: Week 52; end of treatment (EOT) which was planned to occur at Week 104

Timeline

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

24 Sep 201512 Jan 2018

First posted10 Jul 2015 (estimated)
Study start24 Sep 2015
Primary completion12 Jan 2018
Study completion12 Jan 2018

Why it stopped: This study served its purpose in providing considerable safety data.

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 Huntington's 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02494778
Sponsor's protocol ID: TV7820-CNS-20016
Other IDs: 2015-000904-24, 2015
Acronym: Open PRIDE-HD
Status last verified: Aug 2021
First submitted: 7 Jul 2015
Last updated: 17 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30572891

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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All Huntington's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
ClinicalTrials.gov ID: NCT02494778
Acronym / sponsor ID: Open PRIDE-HD / TV7820-CNS-20016
Conditions: Huntington's Disease
Keywords: Huntington's disease, pridopidine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study served its purpose in providing considerable safety data.
Enrolment: 248 participants (actual)
Lead sponsor: PrileniaIndustry (pharma, biotech, devices)
Study start: 24 Sep 2015 (actual)
Primary completion: 12 Jan 2018 (actual)
Study completion: 12 Jan 2018 (actual)
First posted: 10 Jul 2015 (estimated)
Results: Posted 17 Sep 2021

Clinical summary

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

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).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pridopidine	Experimental	Drug: PridopidineThe 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
Similar concomitant medication restrictions to PRIDE HD.

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
PridopidineAlso: TV782045 mg BID	Drug	Pridopidine

Primary outcome

Percentage of Participants With Adverse Events
Time frame: 106 weeks
From signature of the informed consent form through the end of the study, which was defined as Week 106

2 secondary outcomes

Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
Time frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
Time frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104

Results and safety

Results posted to the registry on 17 Sep 2021, 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 45 mg BID	248	27

Primary outcome: Percentage of Participants With Adverse Events

Time frame: 106 weeks. Count of participants. Unit: Participants

Measure	Pridopidine 45 mg BID n = 248
Value	193

Population analysed: All patients enrolled who received at least one dose of study drug

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signature of the informed consent form through the end of the study, which was defined as Week 106. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pridopidine 45 mg BID	31 of 248 (12.5%)	191 of 248 (77%)	3 of 248

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30572891Cohen 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.
Individual participant dataSharing planned: No

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RecruitingObservational study
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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.

Teva Medical Expert, MD study director

Teva Pharmaceuticals USA

46 sites in 11 countries: 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 Huntington's Disease, run by Prilenia at 46 sites in 11 countries.

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 4 inclusion and 3 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, United Kingdom, France, Germany, Italy and 6 more countries. 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. 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 17 Sep 2021). 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?

Percentage of Participants With Adverse Events (time frame: 106 weeks). 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 NCT02494778, 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 17 Sep 2021.