OPEN-HART: Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
Sponsor
Prilenia (Industry)
Overall Status
Completed
CT.gov ID
NCT01306929
Collaborator
(none)
134
1
81.4
Study Details
Study Description
Brief Summary
Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
134 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).
Actual Study Start Date
:
Mar 24, 2011
Actual Primary Completion Date
:
Jan 5, 2018
Actual Study Completion Date
:
Jan 5, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: pridopidine 45mg bid |
Drug: pridopidine
45mg bid
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With at Least One Adverse Event [From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years]
Secondary Outcome Measures
- Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) [Baseline and at Month 12, 24, 36, 48, 60, and 72]
TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is able to, and has provided written Informed Consent prior to any study related procedure.
-
Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
-
Willing and able to take oral medication and able to comply with the study specific procedures.
-
Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.
-
Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.
-
Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
-
Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
-
Newly instigated or changed treatment with neuroleptics/antipsychotics
-
Use of tricyclic antidepressants or class I & III antiarrhythmics at any time during the study period.
-
Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
-
Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
-
Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
-
Females who are pregnant or lactating.
-
Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
-
Known allergy to any ingredients of the trial medication.
-
Additional criteria apply, please contact the investigator for more information
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prilenia
Investigators
- Principal Investigator: See Central Contact section for questions about, study officials
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Prilenia
ClinicalTrials.gov Identifier:
NCT01306929
Other Study ID Numbers:
- ACR16C015
First Posted:
Mar 2, 2011
Last Update Posted:
Feb 9, 2022
Last Verified:
Jan 1, 2022
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study recruited adult patients with Huntington's Disease (HD) who had completed studies ACR16C009 (NCT00724048) or TV7820-CNS-20002 (NCT02006472). The first patient was recruited on 24 Mar 2011, and the last patient completed the trial on 5 Jan 2018. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pridopidine |
|---|---|
| Arm/Group Description | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Period Title: Overall Study | |
| STARTED | 134 |
| COMPLETED | 40 |
| NOT COMPLETED | 94 |
Baseline Characteristics
| Arm/Group Title | Pridopidine |
|---|---|
| Arm/Group Description | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Overall Participants | 134 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.4
(9.98)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
67
50%
|
| Male |
67
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
2.2%
|
| White |
129
96.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
1.5%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
50
37.3%
|
| United States |
84
62.7%
|
| Weight (kg) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg] |
74.7
(18.6)
|
Outcome Measures
| Title | Number of Patients With at Least One Adverse Event |
|---|---|
| Description | |
| Time Frame | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set, including all enrolled patients who received at least 1 dose of study drug. |
| Arm/Group Title | Pridopidine |
|---|---|
| Arm/Group Description | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
119
88.8%
|
| Title | Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) |
|---|---|
| Description | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. |
| Time Frame | Baseline and at Month 12, 24, 36, 48, 60, and 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set, comprising all enrolled patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline UHDRS-TMS assessment. |
| Arm/Group Title | Pridopidine |
|---|---|
| Arm/Group Description | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Measure Participants | 123 |
| Baseline |
38.3
(15.2)
|
| Month 12 |
41.5
(18.7)
|
| Month 24 |
41.7
(20.7)
|
| Month 36 |
44.7
(19.8)
|
| Month 48 |
45.3
(19.7)
|
| Month 60 |
45.7
(20.6)
|
| Month 72 |
50.0
(23.2)
|
Adverse Events
| Time Frame | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pridopidine | |
| Arm/Group Description | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. | |
All Cause Mortality |
||
| Pridopidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/134 (6%) | |
Serious Adverse Events |
||
| Pridopidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 31/134 (23.1%) | |
| Cardiac disorders | ||
| Arteriosclerosis cornonary artery | 1/134 (0.7%) | 1 |
| Bungle branch block right | 1/134 (0.7%) | 1 |
| Cardiac failure congestive | 1/134 (0.7%) | 1 |
| Myocardial infarction | 1/134 (0.7%) | 1 |
| Eye disorders | ||
| Retinal detachment | 1/134 (0.7%) | 1 |
| Gastrointestinal disorders | ||
| Dysphagia | 2/134 (1.5%) | 2 |
| Alcoholic pancreatitis | 1/134 (0.7%) | 1 |
| Intestinal obstruction | 1/134 (0.7%) | 1 |
| Oesophageal spasm | 1/134 (0.7%) | 1 |
| Hepatobiliary disorders | ||
| Cholecystitis | 1/134 (0.7%) | 1 |
| Infections and infestations | ||
| Cellulitis | 1/134 (0.7%) | 1 |
| Clostridium difficile colitis | 1/134 (0.7%) | 1 |
| Device related infection | 1/134 (0.7%) | 1 |
| Endocarditis | 1/134 (0.7%) | 1 |
| Gastroenteritis | 1/134 (0.7%) | 1 |
| Periorbital cellulitis | 1/134 (0.7%) | 1 |
| Pneumonia | 1/134 (0.7%) | 1 |
| Urinary tract infection | 1/134 (0.7%) | 1 |
| Injury, poisoning and procedural complications | ||
| Fall | 4/134 (3%) | 5 |
| Subdural haematoma | 4/134 (3%) | 5 |
| Skull fracture | 2/134 (1.5%) | 2 |
| Brain contusion | 1/134 (0.7%) | 1 |
| Facial bones fracture | 1/134 (0.7%) | 1 |
| Laceration | 1/134 (0.7%) | 1 |
| Rib fracture | 1/134 (0.7%) | 1 |
| Skull fractured base | 1/134 (0.7%) | 1 |
| Tooth fracture | 1/134 (0.7%) | 1 |
| Metabolism and nutrition disorders | ||
| Failure to thrive | 1/134 (0.7%) | 1 |
| Starvation | 1/134 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Spinal column stenosis | 1/134 (0.7%) | 1 |
| Synovial cyst | 1/134 (0.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Colon cancer | 1/134 (0.7%) | 1 |
| Liposarcoma | 1/134 (0.7%) | 1 |
| Multiple myeloma | 1/134 (0.7%) | 2 |
| Nervous system disorders | ||
| Convulsion | 2/134 (1.5%) | 3 |
| Loss of consciousness | 2/134 (1.5%) | 2 |
| Subarachnoid haemorrhage | 2/134 (1.5%) | 2 |
| Balance disorder | 1/134 (0.7%) | 1 |
| Cerebral haemorrhage | 1/134 (0.7%) | 1 |
| Cognitive disorder | 1/134 (0.7%) | 1 |
| Encephalitis | 1/134 (0.7%) | 1 |
| Status migrainosus | 1/134 (0.7%) | 1 |
| Syncope | 1/134 (0.7%) | 1 |
| Psychiatric disorders | ||
| Agitation | 2/134 (1.5%) | 2 |
| Depression | 2/134 (1.5%) | 2 |
| Intentional self-injury | 2/134 (1.5%) | 2 |
| Abnormal behaviour | 1/134 (0.7%) | 1 |
| Aggression | 1/134 (0.7%) | 1 |
| Anxiety | 1/134 (0.7%) | 1 |
| Completed suicide | 1/134 (0.7%) | 1 |
| Delirium | 1/134 (0.7%) | 1 |
| Psychotic disorder | 1/134 (0.7%) | 1 |
| Suicide attempt | 1/134 (0.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumonia aspiration | 3/134 (2.2%) | 3 |
| Respiratory failure | 2/134 (1.5%) | 2 |
| Haemothorax | 1/134 (0.7%) | 1 |
| Vascular disorders | ||
| Haematoma | 1/134 (0.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Pridopidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 119/134 (88.8%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 6/134 (4.5%) | 6 |
| Iron deficiency anaemia | 1/134 (0.7%) | 1 |
| Lymphadenopathy | 1/134 (0.7%) | 1 |
| Cardiac disorders | ||
| Palpitations | 2/134 (1.5%) | 2 |
| Tachycardia | 2/134 (1.5%) | 2 |
| Aortic valve incompetence | 1/134 (0.7%) | 1 |
| Atrioventricular block first degree | 1/134 (0.7%) | 2 |
| Bradycardia | 1/134 (0.7%) | 1 |
| Bundle branch block right | 1/134 (0.7%) | 1 |
| Cardiac failure congestive | 1/134 (0.7%) | 1 |
| Mitral valve incompetence | 1/134 (0.7%) | 1 |
| Myocardial infarction | 1/134 (0.7%) | 1 |
| Tricuspid valve incompetence | 1/134 (0.7%) | 1 |
| Ventricular arrhythmia | 1/134 (0.7%) | 1 |
| Ear and labyrinth disorders | ||
| Ear pain | 2/134 (1.5%) | 3 |
| Cerumen impaction | 1/134 (0.7%) | 1 |
| Ear discomfort | 1/134 (0.7%) | 1 |
| Hypoacusis | 1/134 (0.7%) | 1 |
| Eye disorders | ||
| Asthenopia | 1/134 (0.7%) | 1 |
| Cataract | 1/134 (0.7%) | 2 |
| Conjunctival haemorrhage | 1/134 (0.7%) | 1 |
| Conjunctivitis | 1/134 (0.7%) | 1 |
| Dry eye | 1/134 (0.7%) | 1 |
| Macular degeneration | 1/134 (0.7%) | 1 |
| Photopsia | 1/134 (0.7%) | 1 |
| Retinal tear | 1/134 (0.7%) | 1 |
| Vision blurred | 1/134 (0.7%) | 1 |
| Vitreous floaters | 1/134 (0.7%) | 1 |
| Gastrointestinal disorders | ||
| Diarrhoea | 16/134 (11.9%) | 19 |
| Nausea | 11/134 (8.2%) | 15 |
| Vomiting | 10/134 (7.5%) | 17 |
| Constipation | 7/134 (5.2%) | 7 |
| Dysphagia | 7/134 (5.2%) | 8 |
| Dry mouth | 5/134 (3.7%) | 5 |
| Dental caries | 4/134 (3%) | 4 |
| Dyspepsia | 4/134 (3%) | 4 |
| Faecal incontinence | 4/134 (3%) | 4 |
| Abdominal discomfort | 2/134 (1.5%) | 2 |
| Abdominal pain upper | 2/134 (1.5%) | 2 |
| Colitis ulcerative | 2/134 (1.5%) | 3 |
| Gastroesophageal reflux disease | 2/134 (1.5%) | 2 |
| Haemorrhoids | 2/134 (1.5%) | 3 |
| Abdominal pain | 1/134 (0.7%) | 1 |
| Abdominal tenderness | 1/134 (0.7%) | 1 |
| Diverticulum | 1/134 (0.7%) | 3 |
| Gastritis | 1/134 (0.7%) | 1 |
| Gingival disorder | 1/134 (0.7%) | 1 |
| Hiatus hernia | 1/134 (0.7%) | 1 |
| Hypoaesthesia oral | 1/134 (0.7%) | 1 |
| Inguinal hernia | 1/134 (0.7%) | 1 |
| Oesophagitis | 1/134 (0.7%) | 1 |
| Periodontitis | 1/134 (0.7%) | 1 |
| Salivary hypersecretion | 1/134 (0.7%) | 1 |
| Stomatitis | 1/134 (0.7%) | 1 |
| Tongue disorder | 1/134 (0.7%) | 1 |
| Tooth impacted | 1/134 (0.7%) | 1 |
| Gingivitis | 1/134 (0.7%) | 1 |
| General disorders | ||
| Irritability | 13/134 (9.7%) | 17 |
| Gait disturbance | 8/134 (6%) | 9 |
| Fatigue | 4/134 (3%) | 4 |
| Pyrexia | 4/134 (3%) | 4 |
| Asthenia | 3/134 (2.2%) | 3 |
| Cyst | 3/134 (2.2%) | 3 |
| Oedema peripheral | 2/134 (1.5%) | 4 |
| Chest pain | 1/134 (0.7%) | 1 |
| Facial pain | 1/134 (0.7%) | 1 |
| Influenza like illness | 1/134 (0.7%) | 1 |
| Non-cardiac chest pain | 1/134 (0.7%) | 1 |
| Pain | 1/134 (0.7%) | 1 |
| Hepatobiliary disorders | ||
| Hepatitis | 1/134 (0.7%) | 1 |
| Immune system disorders | ||
| Seasonal allergy | 2/134 (1.5%) | 2 |
| Infections and infestations | ||
| Nasopharyngitis | 16/134 (11.9%) | 22 |
| Upper respiratory tract infection | 9/134 (6.7%) | 17 |
| Sinusitis | 8/134 (6%) | 11 |
| Urinary tract infection | 8/134 (6%) | 19 |
| Bronchitis | 7/134 (5.2%) | 7 |
| Influenza | 6/134 (4.5%) | 9 |
| Gastroenteritis | 4/134 (3%) | 4 |
| Ear infection | 3/134 (2.2%) | 3 |
| Tooth abscess | 3/134 (2.2%) | 3 |
| Clostridium difficile colitis | 2/134 (1.5%) | 3 |
| Fungal skin infection | 2/134 (1.5%) | 2 |
| Furuncle | 2/134 (1.5%) | 2 |
| Herpes zoster | 2/134 (1.5%) | 2 |
| Hordeolum | 2/134 (1.5%) | 2 |
| Onychomycosis | 2/134 (1.5%) | 2 |
| Skin infection | 2/134 (1.5%) | 2 |
| Cellulitis | 1/134 (0.7%) | 1 |
| Cystitis | 1/134 (0.7%) | 4 |
| Diverticulitis | 1/134 (0.7%) | 1 |
| Enterococcal infection | 1/134 (0.7%) | 1 |
| Eye infection | 1/134 (0.7%) | 1 |
| Gingival infection | 1/134 (0.7%) | 1 |
| Infected dermal cyst | 1/134 (0.7%) | 1 |
| Laryngitis | 1/134 (0.7%) | 1 |
| Localised infection | 1/134 (0.7%) | 1 |
| Lower respiratory tract infection | 1/134 (0.7%) | 1 |
| Oral fungal infection | 1/134 (0.7%) | 1 |
| Otitis media | 1/134 (0.7%) | 1 |
| Pharyngitis streptococcal | 1/134 (0.7%) | 1 |
| Pneumonia | 1/134 (0.7%) | 1 |
| Pneumonia bacterial | 1/134 (0.7%) | 1 |
| Rhinitis | 1/134 (0.7%) | 1 |
| Tinea pedis | 1/134 (0.7%) | 1 |
| Viral infection | 1/134 (0.7%) | 1 |
| Vulvovaginal candidiasis | 1/134 (0.7%) | 1 |
| Wound infection | 1/134 (0.7%) | 1 |
| Tooth infection | 4/134 (3%) | 4 |
| Injury, poisoning and procedural complications | ||
| Fall | 46/134 (34.3%) | 148 |
| Contusion | 18/134 (13.4%) | 28 |
| Laceration | 18/134 (13.4%) | 32 |
| Excoriation | 11/134 (8.2%) | 15 |
| Accidental overdose | 3/134 (2.2%) | 3 |
| Head injury | 3/134 (2.2%) | 4 |
| Ligament sprain | 3/134 (2.2%) | 3 |
| Muscle strain | 3/134 (2.2%) | 3 |
| Procedural pain | 3/134 (2.2%) | 3 |
| Rib fracture | 3/134 (2.2%) | 3 |
| Arthropod sting | 2/134 (1.5%) | 2 |
| Clavicle fracture | 2/134 (1.5%) | 3 |
| Facial bones fracture | 2/134 (1.5%) | 2 |
| Lip injury | 2/134 (1.5%) | 3 |
| Overdose | 2/134 (1.5%) | 2 |
| Pelvic fracture | 2/134 (1.5%) | 2 |
| Thermal burn | 2/134 (1.5%) | 4 |
| Tooth fracture | 2/134 (1.5%) | 2 |
| Upper limb fracture | 2/134 (1.5%) | 2 |
| Wrist fracture | 2/134 (1.5%) | 2 |
| Ankle fracture | 1/134 (0.7%) | 1 |
| Compression fracture | 1/134 (0.7%) | 1 |
| Corneal abrasion | 1/134 (0.7%) | 1 |
| Eye injury | 1/134 (0.7%) | 1 |
| Face injury | 1/134 (0.7%) | 1 |
| Foot fracture | 1/134 (0.7%) | 1 |
| Heat exhaustion | 1/134 (0.7%) | 1 |
| Joint injury | 1/134 (0.7%) | 1 |
| Ligament rupture | 1/134 (0.7%) | 1 |
| Limb injury | 1/134 (0.7%) | 1 |
| Lumbar vertebral fracture | 1/134 (0.7%) | 2 |
| Periorbital haematoma | 1/134 (0.7%) | 1 |
| Scratch | 1/134 (0.7%) | 1 |
| Skeletal injury | 1/134 (0.7%) | 1 |
| Soft tissue injury | 1/134 (0.7%) | 1 |
| Spinal column injury | 1/134 (0.7%) | 1 |
| Spinal compression fracture | 1/134 (0.7%) | 1 |
| Subdural haematoma | 1/134 (0.7%) | 2 |
| Thoracic vertebral fracture | 1/134 (0.7%) | 1 |
| Tooth injury | 1/134 (0.7%) | 1 |
| Wound | 1/134 (0.7%) | 1 |
| Investigations | ||
| Weight decreased | 30/134 (22.4%) | 32 |
| Electrocardiogram abnormal | 6/134 (4.5%) | 6 |
| Blood cholesterol increased | 3/134 (2.2%) | 3 |
| Weight increased | 3/134 (2.2%) | 3 |
| Blood potassium increased | 2/134 (1.5%) | 3 |
| Creatinine renal clearance decreased | 2/134 (1.5%) | 2 |
| Prostatic specific antigen increased | 2/134 (1.5%) | 2 |
| Albumin globulin ratio increased | 1/134 (0.7%) | 1 |
| Antibiotic resistant Staphylococcus test positive | 1/134 (0.7%) | 1 |
| Blood calcium decreased | 1/134 (0.7%) | 1 |
| Blood creatinine decreased | 1/134 (0.7%) | 1 |
| Blood creatinine increased | 1/134 (0.7%) | 1 |
| Blood potassium decreased | 1/134 (0.7%) | 1 |
| Blood pressure increased | 1/134 (0.7%) | 1 |
| Body temperature increased | 1/134 (0.7%) | 1 |
| Creatinine renal clearance abnormal | 1/134 (0.7%) | 1 |
| Electrocardiogram ST-T change | 1/134 (0.7%) | 1 |
| Electrocardiogram T wave abnormal | 1/134 (0.7%) | 1 |
| Globulins increased | 1/134 (0.7%) | 1 |
| Glycosylated haemoglobin increased | 1/134 (0.7%) | 1 |
| Heart rate abnormal | 1/134 (0.7%) | 1 |
| Occult blood positive | 1/134 (0.7%) | 1 |
| Protein total increased | 1/134 (0.7%) | 1 |
| Smear cervix abnormal | 1/134 (0.7%) | 1 |
| White blood cell count increased | 1/134 (0.7%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypokalaemia | 5/134 (3.7%) | 12 |
| Dehydration | 3/134 (2.2%) | 4 |
| Hypercholesterolaemia | 3/134 (2.2%) | 3 |
| Decreased appetite | 2/134 (1.5%) | 2 |
| Iron deficiency | 2/134 (1.5%) | 2 |
| Diabetes mellitus | 1/134 (0.7%) | 1 |
| Failure to thrive | 1/134 (0.7%) | 1 |
| Hyperglycaemia | 1/134 (0.7%) | 1 |
| Hyperkalaemia | 1/134 (0.7%) | 1 |
| Hypernatraemia | 1/134 (0.7%) | 1 |
| Hypertriglyceridaemia | 1/134 (0.7%) | 1 |
| Hypovolaemia | 1/134 (0.7%) | 1 |
| Magnesium deficiency | 1/134 (0.7%) | 1 |
| Polydipsia | 1/134 (0.7%) | 1 |
| Type 2 diabetes mellitus | 1/134 (0.7%) | 1 |
| Vitamin B12 deficiency | 1/134 (0.7%) | 1 |
| Vitamin D deficiency | 1/134 (0.7%) | 1 |
| Water intoxication | 1/134 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 7/134 (5.2%) | 10 |
| Pain in extremity | 4/134 (3%) | 4 |
| Arthraglia | 3/134 (2.2%) | 4 |
| Joint swelling | 3/134 (2.2%) | 3 |
| Muscle spasms | 3/134 (2.2%) | 3 |
| Intervertebral disc degeneration | 2/134 (1.5%) | 2 |
| Musculoskeletal pain | 2/134 (1.5%) | 2 |
| Myalgia | 2/134 (1.5%) | 2 |
| Neck pain | 2/134 (1.5%) | 2 |
| Spinal column stenosis | 2/134 (1.5%) | 2 |
| Spinal osteoarthritis | 2/134 (1.5%) | 2 |
| Tendonitis | 2/134 (1.5%) | 2 |
| Joint effusion | 1/134 (0.7%) | 1 |
| Muscular weakness | 1/134 (0.7%) | 2 |
| Ostenopenia | 1/134 (0.7%) | 1 |
| Osteoporosis | 1/134 (0.7%) | 1 |
| Rotator cuff syndrome | 1/134 (0.7%) | 1 |
| Torticollis | 1/134 (0.7%) | 1 |
| Trigger finger | 1/134 (0.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lipoma | 3/134 (2.2%) | 3 |
| Seborrhoeic keratosis | 3/134 (2.2%) | 4 |
| Basal cell carcinoma | 1/134 (0.7%) | 1 |
| Chronic lymphocytic leukaemia | 1/134 (0.7%) | 1 |
| Liposarcoma | 1/134 (0.7%) | 1 |
| Skin cancer | 1/134 (0.7%) | 1 |
| Squamous cell carcinoma | 1/134 (0.7%) | 1 |
| Squamous cell carcinoma of skin | 1/134 (0.7%) | 1 |
| Uterine leiomyoma | 1/134 (0.7%) | 1 |
| Nervous system disorders | ||
| Chorea | 18/134 (13.4%) | 18 |
| Headache | 12/134 (9%) | 20 |
| Dizziness | 7/134 (5.2%) | 8 |
| Amnesia | 4/134 (3%) | 4 |
| Somnolence | 4/134 (3%) | 6 |
| Balance disorder | 3/134 (2.2%) | 3 |
| Dysarthria | 3/134 (2.2%) | 3 |
| Syncope | 3/134 (2.2%) | 4 |
| Speech disorder | 2/134 (1.5%) | 2 |
| Tongue biting | 2/134 (1.5%) | 2 |
| Bradykinesia | 1/134 (0.7%) | 1 |
| Carpal tunnel syndrome | 1/134 (0.7%) | 1 |
| Cervicobrachial syndrome | 1/134 (0.7%) | 1 |
| Cognitive disorder | 1/134 (0.7%) | 1 |
| Convulsion | 1/134 (0.7%) | 2 |
| Dizziness postural | 1/134 (0.7%) | 1 |
| Dystonia | 1/134 (0.7%) | 1 |
| Hemiparesis | 1/134 (0.7%) | 1 |
| Hypoaesthesia | 1/134 (0.7%) | 1 |
| Loss of consciousness | 1/134 (0.7%) | 1 |
| Migraine | 1/134 (0.7%) | 8 |
| Paraesthesia | 1/134 (0.7%) | 1 |
| Presyncope | 1/134 (0.7%) | 1 |
| Restless legs syndrome | 1/134 (0.7%) | 1 |
| Sciatica | 1/134 (0.7%) | 1 |
| Sensory loss | 1/134 (0.7%) | 1 |
| Psychiatric disorders | ||
| Anxiety | 27/134 (20.1%) | 29 |
| Insomnia | 24/134 (17.9%) | 28 |
| Depression | 20/134 (14.9%) | 27 |
| Suicidal ideation | 6/134 (4.5%) | 6 |
| Apathy | 5/134 (3.7%) | 5 |
| Agitation | 4/134 (3%) | 4 |
| Anger | 3/134 (2.2%) | 3 |
| Panic attack | 3/134 (2.2%) | 3 |
| Adjustment disorder | 2/134 (1.5%) | 2 |
| Bruxism | 2/134 (1.5%) | 4 |
| Delusion | 2/134 (1.5%) | 2 |
| Depressed mood | 2/134 (1.5%) | 3 |
| Obsessive-compulsive disorder | 2/134 (1.5%) | 2 |
| Paranoia | 2/134 (1.5%) | 2 |
| Alcohol abuse | 1/134 (0.7%) | 1 |
| Alcohol withdrawal syndrome | 1/134 (0.7%) | 1 |
| Anhedonia | 1/134 (0.7%) | 1 |
| Bradyphrenia | 1/134 (0.7%) | 1 |
| Confusional state | 1/134 (0.7%) | 1 |
| Depressive symptom | 1/134 (0.7%) | 1 |
| Hallucination | 1/134 (0.7%) | 1 |
| Hypomania | 1/134 (0.7%) | 1 |
| Inappropriate affect | 1/134 (0.7%) | 2 |
| Initial insomnia | 1/134 (0.7%) | 1 |
| Nightmare | 1/134 (0.7%) | 1 |
| Obsessive thoughts | 1/134 (0.7%) | 1 |
| Perseveration | 1/134 (0.7%) | 1 |
| Pressure of speech | 1/134 (0.7%) | 1 |
| Rapid eye movements sleep abnormal | 1/134 (0.7%) | 1 |
| Sleep disorder | 1/134 (0.7%) | 1 |
| Tachyphrenia | 1/134 (0.7%) | 1 |
| Renal and urinary disorders | ||
| Urinary incontinence | 9/134 (6.7%) | 10 |
| Hypertonic bladder | 7/134 (5.2%) | 7 |
| Pollakiuria | 4/134 (3%) | 4 |
| Dysuria | 3/134 (2.2%) | 3 |
| Nephrolithiasis | 3/134 (2.2%) | 3 |
| Michurition urgency | 2/134 (1.5%) | 2 |
| Incontinence | 1/134 (0.7%) | 1 |
| Renal cyst | 1/134 (0.7%) | 1 |
| Renal failure acute | 1/134 (0.7%) | 1 |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 2/134 (1.5%) | 2 |
| Genital rash | 1/134 (0.7%) | 1 |
| Gynaecomastia | 1/134 (0.7%) | 1 |
| Menorrhagia | 1/134 (0.7%) | 1 |
| Menstruation irregular | 1/134 (0.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Choking | 5/134 (3.7%) | 5 |
| Cough | 5/134 (3.7%) | 6 |
| Nasal congestion | 3/134 (2.2%) | 3 |
| Pneumonia aspiration | 3/134 (2.2%) | 3 |
| Rhinorrhoea | 3/134 (2.2%) | 4 |
| Sleep apnoea syndrome | 3/134 (2.2%) | 3 |
| Dyspnoea | 2/134 (1.5%) | 2 |
| Oropharyngeal pain | 2/134 (1.5%) | 2 |
| Aspiration | 1/134 (0.7%) | 1 |
| Epistaxis | 1/134 (0.7%) | 1 |
| Grunting | 1/134 (0.7%) | 1 |
| Lung disorder | 1/134 (0.7%) | 1 |
| Upper respiroatry tract congestion | 1/134 (0.7%) | 1 |
| Upper-airway cough syndrome | 1/134 (0.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 10/134 (7.5%) | 13 |
| Skin lesion | 4/134 (3%) | 5 |
| Acne | 2/134 (1.5%) | 2 |
| Alopecia | 2/134 (1.5%) | 2 |
| Dry skin | 2/134 (1.5%) | 2 |
| Eczema | 2/134 (1.5%) | 2 |
| Livedo reticularis | 2/134 (1.5%) | 2 |
| Rash macular | 2/134 (1.5%) | 2 |
| Actinic keratosis | 1/134 (0.7%) | 1 |
| Dermal cyst | 1/134 (0.7%) | 1 |
| Dermatitis contact | 1/134 (0.7%) | 1 |
| Erythema | 1/134 (0.7%) | 1 |
| Generalised erythema | 1/134 (0.7%) | 1 |
| Papule | 1/134 (0.7%) | 1 |
| Pruritis | 1/134 (0.7%) | 1 |
| Rash erythematous | 1/134 (0.7%) | 1 |
| Scar | 1/134 (0.7%) | 1 |
| Seborrhoeic dermatitis | 1/134 (0.7%) | 1 |
| Skin exfoliation | 1/134 (0.7%) | 1 |
| Social circumstances | ||
| Immobilisation prolonged | 1/134 (0.7%) | 1 |
| Vascular disorders | ||
| Hypertension | 4/134 (3%) | 4 |
| Hot flush | 3/134 (2.2%) | 3 |
| Hypotension | 2/134 (1.5%) | 2 |
| Deep vein thrombosis | 1/134 (0.7%) | 1 |
| Haematoma | 1/134 (0.7%) | 1 |
| Lymphoedema | 1/134 (0.7%) | 1 |
| Orthostatic hypotension | 1/134 (0.7%) | 1 |
| Peripheral coldness | 1/134 (0.7%) | 1 |
Limitations/Caveats
The study was stopped at Sponsor discretion/request; last patient last visit was 5 Jan 2018.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Data and results owned by Sponsor. Results can be used by institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
Results Point of Contact
| Name/Title | Prilenia |
|---|---|
| Organization | Prilenia |
| Phone | +972 775558 ext 482 |
| info@prilenia.com |
Responsible Party:
Prilenia
ClinicalTrials.gov Identifier:
NCT01306929
Other Study ID Numbers:
- ACR16C015
First Posted:
Mar 2, 2011
Last Update Posted:
Feb 9, 2022
Last Verified:
Jan 1, 2022