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A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease (Open PRIDE-HD)

Primary Purpose

Huntington's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pridopidine
Sponsored by
Prilenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease focused on measuring Huntington's disease, pridopidine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teva Investigational Site 12204
  • Teva Investigational Site 12201
  • Teva Investigational Site 12196
  • Teva Investigational Site 12206
  • Teva Investigational Site 12200
  • Teva Investigational Site 12203
  • Teva Investigational Site 12198
  • Teva Investigational Site 12211
  • Teva Investigational Site 12209
  • Teva Investigational Site 12208
  • Teva Investigational Site 12210
  • Teva Investigational Site 78055
  • Teva Investigational Site 78058
  • Teva Investigational Site 78057
  • Teva Investigational Site 33021
  • Teva Investigational Site 33027
  • Teva Investigational Site 11036
  • Teva Investigational Site 35123
  • Teva Investigational Site 35122
  • Teva Investigational Site 35125
  • Teva Investigational Site 35124
  • Teva Investigational Site 35121
  • Teva Investigational Site 35165
  • Teva Investigational Site 32408
  • Teva Investigational Site 32410
  • Teva Investigational Site 32409
  • Teva Investigational Site 32407
  • Teva Investigational Site 30083
  • Teva Investigational Site 30080
  • Teva Investigational Site 30082
  • Teva Investigational Site 30081
  • Teva Investigational Site 38059
  • Teva Investigational Site 53150
  • Teva Investigational Site 53149
  • Teva Investigational Site 53148
  • Teva Investigational Site 53151
  • Teva Investigational Site 50215
  • Teva Investigational Site 50213
  • Teva Investigational Site 50214
  • Teva Investigational Site 34058
  • Teva Investigational Site 34054
  • Teva Investigational Site 34059
  • Teva Investigational Site 34055
  • Teva Investigational Site 34061
  • Teva Investigational Site 34056
  • Teva Investigational Site 34057

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pridopidine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 7, 2015
Last Updated
August 23, 2021
Sponsor
Prilenia
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1. Study Identification

Unique Protocol Identification Number
NCT02494778
Brief Title
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Acronym
Open PRIDE-HD
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
This study served its purpose in providing considerable safety data.
Study Start Date
September 24, 2015 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prilenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Huntington's disease, pridopidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pridopidine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pridopidine
Other Intervention Name(s)
TV7820
Intervention Description
45 mg BID
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
From signature of the informed consent form through the end of the study, which was defined as Week 106
Time Frame
106 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
Description
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.
Time Frame
Week 52; end of treatment (EOT) which was planned to occur at Week 104
Title
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
Description
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.
Time Frame
Week 52; end of treatment (EOT) which was planned to occur at Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Pharmaceuticals USA
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 12204
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Teva Investigational Site 12201
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Teva Investigational Site 12196
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Teva Investigational Site 12206
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Teva Investigational Site 12200
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Teva Investigational Site 12203
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Teva Investigational Site 12198
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Teva Investigational Site 12211
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Teva Investigational Site 12209
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Teva Investigational Site 12208
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Teva Investigational Site 12210
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Teva Investigational Site 78055
City
Caulfield South
ZIP/Postal Code
3162
Country
Australia
Facility Name
Teva Investigational Site 78058
City
West Perth
ZIP/Postal Code
6005
Country
Australia
Facility Name
Teva Investigational Site 78057
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Teva Investigational Site 33021
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Teva Investigational Site 33027
City
Wien
ZIP/Postal Code
1010
Country
Austria
Facility Name
Teva Investigational Site 11036
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Teva Investigational Site 35123
City
Angers cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Teva Investigational Site 35122
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Teva Investigational Site 35125
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Teva Investigational Site 35124
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Teva Investigational Site 35121
City
Salouel
ZIP/Postal Code
80054
Country
France
Facility Name
Teva Investigational Site 35165
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Teva Investigational Site 32408
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Teva Investigational Site 32410
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Teva Investigational Site 32409
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Teva Investigational Site 32407
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Teva Investigational Site 30083
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Teva Investigational Site 30080
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Teva Investigational Site 30082
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Teva Investigational Site 30081
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Teva Investigational Site 38059
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Teva Investigational Site 53150
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Teva Investigational Site 53149
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Teva Investigational Site 53148
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Teva Investigational Site 53151
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Teva Investigational Site 50215
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Teva Investigational Site 50213
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Teva Investigational Site 50214
City
Nyznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Teva Investigational Site 34058
City
Birmingham
ZIP/Postal Code
B15 2SG
Country
United Kingdom
Facility Name
Teva Investigational Site 34054
City
Cambridge
ZIP/Postal Code
CB2 2PY
Country
United Kingdom
Facility Name
Teva Investigational Site 34059
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Teva Investigational Site 34055
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Teva Investigational Site 34061
City
Newcastle-Upon-Tyne
ZIP/Postal Code
NE6 4QD
Country
United Kingdom
Facility Name
Teva Investigational Site 34056
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Teva Investigational Site 34057
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30572891
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.
Results Reference
derived

Learn more about this trial

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

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