Clinical trial NCT02494778: A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Huntington's Disease
Keywords: Huntington's disease, pridopidine
Lead sponsor: Prilenia
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 248
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: 106 weeks
Secondary outcomes:
measure: Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
timeFrame: Week 52; end of treatment (EOT) which was planned to occur at Week 104
measure: Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
timeFrame: Week 52; end of treatment (EOT) which was planned to occur at Week 104
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Teva Investigational Site 12204
state: California
city: Englewood
country: United States
facility: Teva Investigational Site 12201
state: Colorado
city: Washington
country: United States
facility: Teva Investigational Site 12196
state: District of Columbia
city: Baltimore
country: United States
facility: Teva Investigational Site 12206
state: Maryland
city: Manhasset
country: United States
facility: Teva Investigational Site 12200
state: New York
city: New York
country: United States
facility: Teva Investigational Site 12203
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 12198
state: New York
city: Winston-Salem
country: United States
facility: Teva Investigational Site 12211
state: North Carolina
city: Pittsburgh
country: United States
facility: Teva Investigational Site 12209
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Teva Investigational Site 12208
state: Utah
city: Richmond
country: United States
facility: Teva Investigational Site 12210
state: Virginia
city: Caulfield South
country: Australia
facility: Teva Investigational Site 78055
city: West Perth
country: Australia
facility: Teva Investigational Site 78058
city: Westmead
country: Australia
facility: Teva Investigational Site 78057
city: Innsbruck
country: Austria
facility: Teva Investigational Site 33021
city: Wien
country: Austria
facility: Teva Investigational Site 33027
city: Toronto
country: Canada
facility: Teva Investigational Site 11036
state: Ontario
city: Angers cedex 9
country: France
facility: Teva Investigational Site 35123
city: Creteil
country: France
facility: Teva Investigational Site 35122
city: Lille Cedex
country: France
facility: Teva Investigational Site 35125
city: Marseille Cedex 5
country: France
facility: Teva Investigational Site 35124
city: Salouel
country: France
facility: Teva Investigational Site 35121
city: Toulouse
country: France
facility: Teva Investigational Site 35165
city: Berlin
country: Germany
facility: Teva Investigational Site 32408
city: Bochum
country: Germany
facility: Teva Investigational Site 32410
city: Munster
country: Germany
facility: Teva Investigational Site 32409
city: Ulm
country: Germany
facility: Teva Investigational Site 32407
city: Firenze
country: Italy
facility: Teva Investigational Site 30083
city: Milano
country: Italy
facility: Teva Investigational Site 30080
city: Napoli
country: Italy
facility: Teva Investigational Site 30082
city: San Giovanni Rotondo
country: Italy
facility: Teva Investigational Site 30081
city: Leiden
country: Netherlands
facility: Teva Investigational Site 38059
city: Gdansk
country: Poland
facility: Teva Investigational Site 53150
city: Krakow
country: Poland
facility: Teva Investigational Site 53149
city: Poznan
country: Poland
facility: Teva Investigational Site 53148
city: Warsaw
country: Poland
facility: Teva Investigational Site 53151
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50215
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50213
city: Nyznij Novgorod
country: Russian Federation
facility: Teva Investigational Site 50214
city: Birmingham
country: United Kingdom
facility: Teva Investigational Site 34058
city: Cambridge
country: United Kingdom
facility: Teva Investigational Site 34054
city: Cardiff
country: United Kingdom
facility: Teva Investigational Site 34059
city: Manchester
country: United Kingdom
facility: Teva Investigational Site 34055
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Teva Investigational Site 34061
city: Oxford
country: United Kingdom
facility: Teva Investigational Site 34056
city: Sheffield
country: United Kingdom
facility: Teva Investigational Site 34057
Study officials:
affiliation: Teva Pharmaceuticals USA
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.