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

• Sponsor: Prilenia (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02494778
• Collaborator: (none)
• Enrollment: 248
• Locations: 46
• Arm: 1
• Actual Duration (Months): 27.6
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Huntington's Disease	Drug: Pridopidine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 248 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Sep 24, 2015
• Actual Primary Completion Date: Jan 12, 2018
• Actual Study Completion Date: Jan 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pridopidine 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.	Drug: Pridopidine; 45 mg BID; Other Names: TV7820

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Adverse Events [106 weeks]

   From signature of the informed consent form through the end of the study, which was defined as Week 106

Secondary Outcome Measures

1. Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand [Week 52; end of treatment (EOT) which was planned to occur at Week 104]

   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.

2. Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand [Week 52; end of treatment (EOT) which was planned to occur at Week 104]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 12204	Los Angeles	California	United States	90095
2	Teva Investigational Site 12201	Englewood	Colorado	United States	80113
3	Teva Investigational Site 12196	Washington	District of Columbia	United States	20007
4	Teva Investigational Site 12206	Baltimore	Maryland	United States	21287
5	Teva Investigational Site 12200	Manhasset	New York	United States	11030
6	Teva Investigational Site 12203	New York	New York	United States	10032
7	Teva Investigational Site 12198	Rochester	New York	United States	14618
8	Teva Investigational Site 12211	Winston-Salem	North Carolina	United States	27157
9	Teva Investigational Site 12209	Pittsburgh	Pennsylvania	United States	15213
10	Teva Investigational Site 12208	Salt Lake City	Utah	United States	84108
11	Teva Investigational Site 12210	Richmond	Virginia	United States	23230
12	Teva Investigational Site 78055	Caulfield South		Australia	3162
13	Teva Investigational Site 78058	West Perth		Australia	6005
14	Teva Investigational Site 78057	Westmead		Australia	2145
15	Teva Investigational Site 33021	Innsbruck		Austria	A-6020
16	Teva Investigational Site 33027	Wien		Austria	1010
17	Teva Investigational Site 11036	Toronto	Ontario	Canada	M3B 2S7
18	Teva Investigational Site 35123	Angers cedex 9		France	49933
19	Teva Investigational Site 35122	Creteil		France	94010
20	Teva Investigational Site 35125	Lille Cedex		France	59037
21	Teva Investigational Site 35124	Marseille Cedex 5		France	13385
22	Teva Investigational Site 35121	Salouel		France	80054
23	Teva Investigational Site 35165	Toulouse		France	31059
24	Teva Investigational Site 32408	Berlin		Germany	10117
25	Teva Investigational Site 32410	Bochum		Germany	44791
26	Teva Investigational Site 32409	Munster		Germany	48149
27	Teva Investigational Site 32407	Ulm		Germany	89081
28	Teva Investigational Site 30083	Firenze		Italy	50134
29	Teva Investigational Site 30080	Milano		Italy	20133
30	Teva Investigational Site 30082	Napoli		Italy	80131
31	Teva Investigational Site 30081	San Giovanni Rotondo		Italy	71013
32	Teva Investigational Site 38059	Leiden		Netherlands	2333 ZA
33	Teva Investigational Site 53150	Gdansk		Poland	80-462
34	Teva Investigational Site 53149	Krakow		Poland	31-505
35	Teva Investigational Site 53148	Poznan		Poland	60-529
36	Teva Investigational Site 53151	Warsaw		Poland	02-957
37	Teva Investigational Site 50215	Kazan		Russian Federation	420101
38	Teva Investigational Site 50213	Moscow		Russian Federation	125367
39	Teva Investigational Site 50214	Nyznij Novgorod		Russian Federation	603126
40	Teva Investigational Site 34058	Birmingham		United Kingdom	B15 2SG
41	Teva Investigational Site 34054	Cambridge		United Kingdom	CB2 2PY
42	Teva Investigational Site 34059	Cardiff		United Kingdom	CF14 4XN
43	Teva Investigational Site 34055	Manchester		United Kingdom	M13 9WL
44	Teva Investigational Site 34061	Newcastle-Upon-Tyne		United Kingdom	NE6 4QD
45	Teva Investigational Site 34056	Oxford		United Kingdom	OX3 9DU
46	Teva Investigational Site 34057	Sheffield		United Kingdom	S10 2JF

Sponsors and Collaborators

• Prilenia

Investigators

• Study Director: Teva Medical Expert, MD, Teva Pharmaceuticals USA

Study Documents (Full-Text)

• Study Protocol - Mar 31, 2016
• Statistical Analysis Plan - Jan 11, 2018

More Information

Publications

None provided.

• Responsible Party: Prilenia
• ClinicalTrials.gov Identifier: NCT02494778
• Other Study ID Numbers: TV7820-CNS-20016; 2015-000904-24
• First Posted: Jul 10, 2015
• Last Update Posted: Sep 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prilenia: Huntington's disease, pridopidine
• Additional relevant MeSH terms: Huntington Disease

Study Results

Participant Flow

Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Period Title: Overall Study
STARTED	248
COMPLETED	27
NOT COMPLETED	221

Baseline Characteristics

Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Overall Participants	248
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (11.61)
Sex: Female, Male (Count of Participants)
Female	129 52%
Male	119 48%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 0.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	227 91.5%
More than one race	0 0%
Unknown or Not Reported	19 7.7%
Region of Enrollment (participants) [Number]
Canada	4 1.6%
Austria	18 7.3%
Netherlands	9 3.6%
United States	34 13.7%
Poland	28 11.3%
Italy	34 13.7%
United Kingdom	28 11.3%
France	18 7.3%
Australia	9 3.6%
Germany	32 12.9%
Russia	34 13.7%
CYP2D6 metaboliser genotype (Count of Participants)
Poor metaboliser	8 3.2%
Extensive metaboliser	214 86.3%
Intermediate metaboliser	25 10.1%
Ultra-rapid metaboliser	1 0.4%
Neuroleptic use (Count of Participants)
Yes	94 37.9%
No	154 62.1%
Number of CAG repeats (CAG repeats) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [CAG repeats]	44.8 (4.01)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Measure Participants	248
Count of Participants [Participants]	193 77.8%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled who received at least 1 dose of study drug and had at least 1 post-baseline UHDRS-TMS assessment.

Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Measure Participants	146
Change from baseline to Week 52	0.0 (0.05)
Change from baseline to EOT	-0.1 (0.01)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled who received at least 1 dose of study drug and had at least 1 post-baseline UHDRS-TMS assessment.

Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Measure Participants	146
Change from baseline to Week 52	-2.9 (9.31)
Change from baseline to EOT	-5.9 (8.05)

Adverse Events

Time Frame	From signature of the informed consent form through the end of the study, which was defined as Week 106
Arm/Group Title	Pridopidine 45 mg BID
Arm/Group Description	Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
All Cause Mortality
	Pridopidine 45 mg BID
	Affected / at Risk (%)	# Events
Total	3/248 (1.2%)
Serious Adverse Events
	Pridopidine 45 mg BID
	Affected / at Risk (%)	# Events
Total	31/248 (12.5%)
Blood and lymphatic system disorders
Anaemia	1/248 (0.4%)	1
Congenital, familial and genetic disorders
Huntington's disease	1/248 (0.4%)	1
Gastrointestinal disorders
Dysphagia	1/248 (0.4%)	1
Gastrointestinal polyp haemorrhage	1/248 (0.4%)	1
General disorders
Death	1/248 (0.4%)	1
Gait disturbance	1/248 (0.4%)	1
Hepatobiliary disorders
Drug-induced liver injury	1/248 (0.4%)	1
Infections and infestations
Pneumonia	2/248 (0.8%)	2
Diverticulitis	1/248 (0.4%)	1
Urinary tract infection	1/248 (0.4%)	1
Urosepsis	1/248 (0.4%)	1
Injury, poisoning and procedural complications
Fall	4/248 (1.6%)	4
Subdural haematoma	2/248 (0.8%)	2
Ankle fracture	1/248 (0.4%)	1
Brain contusion	1/248 (0.4%)	1
Contusion	1/248 (0.4%)	1
Craniocerebral injury	1/248 (0.4%)	1
Extradural haematoma	1/248 (0.4%)	1
Facial bones fracture	1/248 (0.4%)	1
Head injury	1/248 (0.4%)	1
Skull fracture	1/248 (0.4%)	1
Skull fractured base	1/248 (0.4%)	1
Tibia fracture	1/248 (0.4%)	1
Toxicity to varios agents	1/248 (0.4%)	1
Investigations
Weight decreased	1/248 (0.4%)	1
Metabolism and nutrition disorders
Cachexia	1/248 (0.4%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/248 (0.4%)	1
Pain in extremity	1/248 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/248 (0.4%)	1
Malignant melanoma in situ	1/248 (0.4%)	1
Prostate cancer	1/248 (0.4%)	1
Squamous cell carcinoma	1/248 (0.4%)	1
Nervous system disorders
Chorea	3/248 (1.2%)	3
Dystonia	1/248 (0.4%)	1
Haemorrhage intracranial	1/248 (0.4%)	1
Peripheral nerve palsy	1/248 (0.4%)	1
Subarachnoid haemorrhage	1/248 (0.4%)	1
Syncope	1/248 (0.4%)	1
Transient ischaemic attack	1/248 (0.4%)	1
Psychiatric disorders
Suicidal ideation	3/248 (1.2%)	3
Depression	1/248 (0.4%)	1
Hallucination, auditory	1/248 (0.4%)	1
Paranoia	1/248 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/248 (0.4%)	1
Pulmonary embolism	1/248 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Pridopidine 45 mg BID
	Affected / at Risk (%)	# Events
Total	191/248 (77%)
Infections and infestations
Nasopharyngitis	29/248 (11.7%)	36
Injury, poisoning and procedural complications
Fall	74/248 (29.8%)	163
Contusion	13/248 (5.2%)	20
Investigations
Weight decreased	13/248 (5.2%)	13
Musculoskeletal and connective tissue disorders
Back pain	14/248 (5.6%)	15
Nervous system disorders
Chorea	23/248 (9.3%)	30
Headache	14/248 (5.6%)	19
Psychiatric disorders
Insomnia	20/248 (8.1%)	27
Anxiety	16/248 (6.5%)	17

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Data and results are owned by the sponsor. Results can be used by the institution for internal noncommercial research, education and patient care, and as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.