An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Sponsor
Solstice Neurosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00702754
Collaborator
(none)
502
87
Study Details
Study Description
Brief Summary
Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study patients will receive repeat injections of MYOBLOC when deemed appropriate by the Investigator. However, it will be recommended that injections occur not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
502 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Study Start Date
:
Jun 1, 2001
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
Sep 1, 2008
Outcome Measures
Primary Outcome Measures
- Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms [Session 1 - Time 0, 4 weeks post-injection compared to baseline]
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Secondary Outcome Measures
- Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 2 (12 wks) - 4 weeks post-injection compared to baseline]
7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 3 (24 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 4 (36 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 5 (48 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 6 (60 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 7 (72 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
- Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms [Session 8 (84 Wks) - 4 weeks post-injection compared to baseline]
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 years of age or older
-
body weight of at least 46 kilograms
-
History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Exclusion Criteria:
-
Inability to give informed consent
-
Patient who has been previously treated with botulinum Toxin Type B
-
Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
-
History of phenol injections involving the neck or shoulder region in the last 12 months.
-
Patients with neck contractures or cervical spine disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Solstice Neurosciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Solstice Neurosciences
ClinicalTrials.gov Identifier:
NCT00702754
Other Study ID Numbers:
- 401CDNA
- 401CDNA
First Posted:
Jun 20, 2008
Last Update Posted:
May 10, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Approximately 500 subjects were recruited from 36 centers in North America. |
|---|---|
| Pre-assignment Detail | Subjects had to be Botulinum Toxin Type B naive and could not have received a Botulinum Toxin Type A treatment within 12 weeks of enrollment. |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 502 |
| COMPLETED | 495 |
| NOT COMPLETED | 7 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 495 |
| COMPLETED | 475 |
| NOT COMPLETED | 20 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 475 |
| COMPLETED | 450 |
| NOT COMPLETED | 25 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 450 |
| COMPLETED | 428 |
| NOT COMPLETED | 22 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 428 |
| COMPLETED | 396 |
| NOT COMPLETED | 32 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 396 |
| COMPLETED | 377 |
| NOT COMPLETED | 19 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 377 |
| COMPLETED | 353 |
| NOT COMPLETED | 24 |
| Period Title: MYOBLOC Treatment Session 1 (Time 0) | |
| STARTED | 353 |
| COMPLETED | 329 |
| NOT COMPLETED | 24 |
Baseline Characteristics
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Overall Participants | 502 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
419
83.5%
|
| >=65 years |
83
16.5%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54
(11)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
341
67.9%
|
| Male |
161
32.1%
|
| Region of Enrollment (participants) [Number] | |
| North America |
502
100%
|
Outcome Measures
| Title | Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 1 - Time 0, 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 495 |
| Mean (Standard Error) [points on a scale] |
0.9
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 2 (12 wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 475 |
| Mean (Standard Deviation) [points on a scale] |
1.3
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 3 (24 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 450 |
| Mean (Standard Deviation) [points on a scale] |
1.5
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 4 (36 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 428 |
| Mean (Standard Deviation) [points on a scale] |
1.4
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 5 (48 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 396 |
| Mean (Standard Deviation) [points on a scale] |
1.5
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 6 (60 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 377 |
| Mean (Standard Deviation) [points on a scale] |
1.4
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 7 (72 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 353 |
| Mean (Standard Deviation) [points on a scale] |
1.5
(0.1)
|
| Title | Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms |
|---|---|
| Description | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Time Frame | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population/Intent to Treat |
| Arm/Group Title | MYOBLOC Open Label Treatment |
|---|---|
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. |
| Measure Participants | 329 |
| Mean (Standard Deviation) [points on a scale] |
1.4
(0.1)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | MYOBLOC Open Label Treatment | |
| Arm/Group Description | All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks. | |
All Cause Mortality |
||
| MYOBLOC Open Label Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| MYOBLOC Open Label Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 133/ (NaN) | |
| Cardiac disorders | ||
| Acute Coronary Syndrome | 8/502 (1.6%) | 8 |
| Acute Myocardial Infarction | 1/502 (0.2%) | 1 |
| Angina | 1/502 (0.2%) | 1 |
| Atrial Fibrillation | 3/502 (0.6%) | 3 |
| AV Block 2nd Degree | 1/502 (0.2%) | 1 |
| Coronary Artery Occlusion | 1/502 (0.2%) | 1 |
| Bradycardia | 1/502 (0.2%) | 1 |
| Myocardial infarction | 2/502 (0.4%) | 2 |
| Palpitations | 1/502 (0.2%) | 1 |
| Pericardial effusion | 1/502 (0.2%) | 1 |
| sinus bradycardia | 1/502 (0.2%) | 1 |
| tachycardia | 1/502 (0.2%) | 1 |
| Ear and labyrinth disorders | ||
| vertigo | 1/502 (0.2%) | 1 |
| Endocrine disorders | ||
| adrenal insufficiency | 1/502 (0.2%) | 1 |
| Eye disorders | ||
| eye haemorrhage | 1/502 (0.2%) | 1 |
| Gastrointestinal disorders | ||
| abdominal adhesions | 1/502 (0.2%) | 1 |
| abdominal pain | 2/502 (0.4%) | 2 |
| appendicitis | 1/502 (0.2%) | 1 |
| celiac disease | 1/502 (0.2%) | 1 |
| constipation | 1/502 (0.2%) | 1 |
| diarrhea | 1/502 (0.2%) | 1 |
| diverticulum | 1/502 (0.2%) | 1 |
| dysphagia | 1/502 (0.2%) | 1 |
| GI hemorrhage | 3/502 (0.6%) | 3 |
| GI Reflux disease | 1/502 (0.2%) | 1 |
| inguinal hernia | 1/502 (0.2%) | 1 |
| inguinal hernia obsstructive | 1/502 (0.2%) | 1 |
| nausea | 1/502 (0.2%) | 1 |
| pancreatitis | 1/502 (0.2%) | 1 |
| small intestine obstruction | 1/502 (0.2%) | 1 |
| upper GI hemorrhage | 1/502 (0.2%) | 1 |
| vomiting | 2/502 (0.4%) | 2 |
| General disorders | ||
| chest discomfort | 1/502 (0.2%) | 1 |
| chest pain | 4/502 (0.8%) | 4 |
| facial pain | 1/502 (0.2%) | 1 |
| non cardiac chest pain | 1/502 (0.2%) | 1 |
| pain | 1/502 (0.2%) | 1 |
| Hepatobiliary disorders | ||
| bile duct stone | 1/502 (0.2%) | 1 |
| cholecystitis | 1/502 (0.2%) | 1 |
| cholecystitis acute | 1/502 (0.2%) | 1 |
| cholelithiasis | 4/502 (0.8%) | 4 |
| hepatorenal syndrome | 1/502 (0.2%) | 1 |
| jaundice | 1/502 (0.2%) | 1 |
| Immune system disorders | ||
| hypersensitivity | 1/502 (0.2%) | 1 |
| Infections and infestations | ||
| abdominal abscess | 1/502 (0.2%) | 1 |
| appendicitis | 1/502 (0.2%) | 1 |
| arthritis infective | 1/502 (0.2%) | 1 |
| bartholin abscess | 1/502 (0.2%) | 1 |
| GI norwalk virus | 1/502 (0.2%) | 1 |
| GI viral | 1/502 (0.2%) | 1 |
| haemophilis infection | 1/502 (0.2%) | 1 |
| pelvic abscess | 1/502 (0.2%) | 1 |
| pneumonia | 2/502 (0.4%) | 2 |
| post operative abscess | 1/502 (0.2%) | 1 |
| pyelonephritis | 1/502 (0.2%) | 1 |
| sinusitis | 1/502 (0.2%) | 1 |
| Upper Respiratory Infection (URI) | 1/502 (0.2%) | 1 |
| Urinary Tract Infection (UTI) | 1/502 (0.2%) | 1 |
| vaginal cellulitis | 1/502 (0.2%) | 1 |
| drug toxicitiy | 1/502 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||
| accidental overdose | 1/502 (0.2%) | 1 |
| brain contusion | 1/502 (0.2%) | 1 |
| clavicle fracture | 1/502 (0.2%) | 1 |
| fall | 1/502 (0.2%) | 1 |
| hip fracture | 3/502 (0.6%) | 3 |
| incisional hernia | 2/502 (0.4%) | 2 |
| medication error | 1/502 (0.2%) | 1 |
| multiple fractures | 1/502 (0.2%) | 1 |
| overdose | 20/502 (4%) | 20 |
| post procedural nausea | 1/502 (0.2%) | 1 |
| post pocedural vomiting | 1/502 (0.2%) | 1 |
| post operative ileus | 1/502 (0.2%) | 1 |
| road traffic accident | 4/502 (0.8%) | 4 |
| subdural hematoma | 1/502 (0.2%) | 1 |
| upper limb fracture | 1/502 (0.2%) | 1 |
| Investigations | ||
| oxygen saturation decrease | 1/502 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||
| dehydration | 3/502 (0.6%) | 3 |
| hyperglycemia | 1/502 (0.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| arthralgia | 1/502 (0.2%) | 1 |
| arthritis | 1/502 (0.2%) | 1 |
| back disorder | 1/502 (0.2%) | 1 |
| back pain | 1/502 (0.2%) | 1 |
| intervebral disc degeneration | 2/502 (0.4%) | 2 |
| intervebral disc protrusion | 2/502 (0.4%) | 2 |
| muscle spasm | 1/502 (0.2%) | 1 |
| musculoskeletal chest pain | 1/502 (0.2%) | 1 |
| osteoarthritis | 2/502 (0.4%) | 2 |
| rotator cuff syndrome | 1/502 (0.2%) | 1 |
| spinal osteoarthritis | 2/502 (0.4%) | 2 |
| torticollis | 7/502 (1.4%) | 7 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| basal cell carcinoma | 4/502 (0.8%) | 4 |
| basosquamous carcinoma | 1/502 (0.2%) | 1 |
| benign ovarian tumor | 1/502 (0.2%) | 1 |
| bone neoplasm malignant | 1/502 (0.2%) | 1 |
| brain neoplasm | 1/502 (0.2%) | 1 |
| breast cancer | 5/502 (1%) | 5 |
| keratocanthoma | 1/502 (0.2%) | 1 |
| lung neoplasm malignant | 1/502 (0.2%) | 1 |
| malignant neoplasm progression | 1/502 (0.2%) | 1 |
| prostate cancer | 2/502 (0.4%) | 2 |
| skin cancer | 1/502 (0.2%) | 1 |
| squamous cell carcinoma | 2/502 (0.4%) | 2 |
| squamous cell carcinoma of skin | 1/502 (0.2%) | 1 |
| uterine leiomyoma | 1/502 (0.2%) | 1 |
| vulval cancer | 1/502 (0.2%) | 1 |
| Nervous system disorders | ||
| Cerebrovascular Accident (CVA) | 3/502 (0.6%) | 3 |
| cervical myelopathy | 2/502 (0.4%) | 2 |
| convulsion | 1/502 (0.2%) | 1 |
| Dementia | 1/502 (0.2%) | 1 |
| Dizziness | 2/502 (0.4%) | 2 |
| dystonia | 1/502 (0.2%) | 1 |
| epilepsy | 1/502 (0.2%) | 1 |
| intracranial aneurysm | 1/502 (0.2%) | 1 |
| mutiple sclerosis | 2/502 (0.4%) | 2 |
| syncope | 1/502 (0.2%) | 1 |
| vertebrobasilar insufficiency | 1/502 (0.2%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||
| pregnancy | 2/502 (0.4%) | 2 |
| Psychiatric disorders | ||
| anxiety | 1/502 (0.2%) | 1 |
| confusional state | 1/502 (0.2%) | 1 |
| depression | 3/502 (0.6%) | 3 |
| dissociative identity disorder | 1/502 (0.2%) | 1 |
| major depression | 1/502 (0.2%) | 1 |
| suicidal ideation | 3/502 (0.6%) | 3 |
| Renal and urinary disorders | ||
| bladder prolapse | 1/502 (0.2%) | 1 |
| renal failure acute | 1/502 (0.2%) | 1 |
| stress incontinence | 1/502 (0.2%) | 1 |
| Reproductive system and breast disorders | ||
| cystocele | 1/502 (0.2%) | 1 |
| endometriosis | 1/502 (0.2%) | 1 |
| menorrhagia | 1/502 (0.2%) | 1 |
| ovarian cyst | 1/502 (0.2%) | 1 |
| ovarian cyst rupture | 1/502 (0.2%) | 1 |
| pelvic peritoneal adhesions | 1/502 (0.2%) | 1 |
| rectocele | 1/502 (0.2%) | 1 |
| atelectasis | 2/502 (0.4%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| choking | 1/502 (0.2%) | 1 |
| Chronic Obstructive Pulmonary Disease | 2/502 (0.4%) | 2 |
| dyspnea | 2/502 (0.4%) | 2 |
| pulmonary embolism | 2/502 (0.4%) | 2 |
| pulmonary edema | 1/502 (0.2%) | 1 |
| sleep apnea syndrome | 1/502 (0.2%) | 1 |
| Vascular disorders | ||
| blood pressure fluctuation | 1/502 (0.2%) | 1 |
| deep vein thrombosis | 1/502 (0.2%) | 1 |
| haemotoma | 1/502 (0.2%) | 1 |
| hypertension | 3/502 (0.6%) | 3 |
Other (Not Including Serious) Adverse Events |
||
| MYOBLOC Open Label Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 494/ (NaN) | |
| Cardiac disorders | ||
| Palpitations | 11/502 (2.2%) | 11 |
| Ear and labyrinth disorders | ||
| vertigo | 18/502 (3.6%) | 18 |
| Endocrine disorders | ||
| hypothyroidism | 10/502 (2%) | 10 |
| Eye disorders | ||
| cataract | 10/502 (2%) | 10 |
| conjunctivitis | 11/502 (2.2%) | 11 |
| dry eye | 10/502 (2%) | 10 |
| vision blurred | 12/502 (2.4%) | 12 |
| Gastrointestinal disorders | ||
| abdominal pain | 29/502 (5.8%) | 29 |
| abdominal pain upper | 15/502 (3%) | 15 |
| constipation | 43/502 (8.6%) | 43 |
| diarrhea | 48/502 (9.6%) | 48 |
| dry mouth | 348/502 (69.3%) | 348 |
| dyspepsia | 48/502 (9.6%) | 48 |
| dysphagia | 203/502 (40.4%) | 203 |
| GERD | 42/502 (8.4%) | 42 |
| nausea | 72/502 (14.3%) | 72 |
| toothache | 10/502 (2%) | 10 |
| vomiting | 30/502 (6%) | 30 |
| General disorders | ||
| asthenia | 12/502 (2.4%) | 12 |
| chest pain | 28/502 (5.6%) | 28 |
| fatigue | 51/502 (10.2%) | 51 |
| influenza like illness | 25/502 (5%) | 25 |
| injection site pain | 114/502 (22.7%) | 114 |
| injection site reaction | 15/502 (3%) | 15 |
| edema peripheral | 26/502 (5.2%) | 26 |
| pyrexia | 12/502 (2.4%) | 12 |
| Infections and infestations | ||
| bronchitis | 50/502 (10%) | 50 |
| cystitis | 18/502 (3.6%) | 18 |
| ear infection | 10/502 (2%) | 10 |
| fungal infection | 10/502 (2%) | 10 |
| GI viral | 24/502 (4.8%) | 24 |
| herpes zoster | 10/502 (2%) | 10 |
| influenza | 84/502 (16.7%) | 84 |
| nasopharyngitis | 110/502 (21.9%) | 110 |
| otitis media | 18/502 (3.6%) | 18 |
| pneumonia | 10/502 (2%) | 10 |
| sinusitis | 68/502 (13.5%) | 68 |
| tooth abscess | 14/502 (2.8%) | 14 |
| Upper Respiratory Infection | 70/502 (13.9%) | 70 |
| Injury, poisoning and procedural complications | ||
| joint sprain | 15/502 (3%) | 15 |
| muscle sprain | 10/502 (2%) | 10 |
| overdose | 20/502 (4%) | 20 |
| procedural pain | 25/502 (5%) | 25 |
| road traffic accident | 16/502 (3.2%) | 16 |
| Investigations | ||
| blood cholesterol increased | 11/502 (2.2%) | 11 |
| Metabolism and nutrition disorders | ||
| hypercholesterolemia | 22/502 (4.4%) | 22 |
| Musculoskeletal and connective tissue disorders | ||
| arthralgia | 61/502 (12.2%) | 61 |
| arthritis | 18/502 (3.6%) | 18 |
| back pain | 77/502 (15.3%) | 77 |
| intervertebral disc degeneration | 12/502 (2.4%) | 12 |
| interverterbral disc protrusion | 11/502 (2.2%) | 11 |
| muscle spasm | 77/502 (15.3%) | 77 |
| muscle tightness | 13/502 (2.6%) | 13 |
| muscle weakness | 41/502 (8.2%) | 41 |
| musculoskeletal weakness | 20/502 (4%) | 20 |
| myalgia | 25/502 (5%) | 25 |
| neck pain | 32/502 (6.4%) | 32 |
| osteoarthritis | 18/502 (3.6%) | 18 |
| pain in extremity | 56/502 (11.2%) | 56 |
| rotator cuff syndrome | 15/502 (3%) | 15 |
| shoulder pain | 29/502 (5.8%) | 29 |
| tendonitis | 15/502 (3%) | 15 |
| torticollis | 170/502 (33.9%) | 170 |
| Nervous system disorders | ||
| balance disorder | 13/502 (2.6%) | 13 |
| carpal tunnel syndrome | 11/502 (2.2%) | 11 |
| dizziness | 68/502 (13.5%) | 68 |
| head titubation | 29/502 (5.8%) | 29 |
| headache | 117/502 (23.3%) | 117 |
| hypoaesthesia | 46/502 (9.2%) | 46 |
| Migraine | 22/502 (4.4%) | 22 |
| paraesthesia | 31/502 (6.2%) | 31 |
| Somnolence | 19/502 (3.8%) | 19 |
| syncope | 12/502 (2.4%) | 12 |
| tremor | 33/502 (6.6%) | 33 |
| Psychiatric disorders | ||
| anxiety | 36/502 (7.2%) | 36 |
| depression | 67/502 (13.3%) | 67 |
| insomnia | 46/502 (9.2%) | 46 |
| stress | 12/502 (2.4%) | 12 |
| Respiratory, thoracic and mediastinal disorders | ||
| choking | 14/502 (2.8%) | 14 |
| cough | 51/502 (10.2%) | 51 |
| dry throat | 15/502 (3%) | 15 |
| dysphonia | 10/502 (2%) | 10 |
| dyspnea | 19/502 (3.8%) | 19 |
| nasal congestion | 17/502 (3.4%) | 17 |
| pharangolaryngeal pain | 36/502 (7.2%) | 36 |
| Skin and subcutaneous tissue disorders | ||
| pruritis | 10/502 (2%) | 10 |
| rash | 31/502 (6.2%) | 31 |
| Vascular disorders | ||
| hypertension | 43/502 (8.6%) | 43 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
No individual PI can disclose results until after a group manuscript is published.
Results Point of Contact
| Name/Title | Regulatory Affairs Specialist |
|---|---|
| Organization | Solstice Neurosciences, Inc |
| Phone | |
| regulatoryaffairs@usworldmeds.com |
Responsible Party:
Solstice Neurosciences
ClinicalTrials.gov Identifier:
NCT00702754
Other Study ID Numbers:
- 401CDNA
- 401CDNA
First Posted:
Jun 20, 2008
Last Update Posted:
May 10, 2019
Last Verified:
Apr 1, 2019