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An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00702754
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : September 23, 2009
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC ( Solstice Neurosciences )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Dystonia
Intervention Biological: Botulinum Toxin Type B
Enrollment 502
Recruitment Details Approximately 500 subjects were recruited from 36 centers in North America.
Pre-assignment Details 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
Hide 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 [1]
Not Completed 7
[1]
Approximately 70% of subjects completed at least 2 years of treatment.
Period Title: MYOBLOC Treatment Session 2 (App 12 Wks)
Started 495
Completed 475
Not Completed 20
Period Title: MYOBLOC Treatment Session 3 (App 24 Wks)
Started 475
Completed 450
Not Completed 25
Period Title: MYOBLOC Treatment Session 4 (App 36 Wks)
Started 450
Completed 428
Not Completed 22
Period Title: MYOBLOC Treatment Session 5 (App 48 Wks)
Started 428
Completed 396
Not Completed 32
Period Title: MYOBLOC Treatment Session 6 (App 60 Wks)
Started 396
Completed 377
Not Completed 19
Period Title: MYOBLOC Treatment Session 7 (App 72 Wks)
Started 377
Completed 353
Not Completed 24
Period Title: MYOBLOC Treatment Session 8 (App 84 Wks)
Started 353
Completed 329
Not Completed 24
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Baseline Participants 502
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 502 participants
<=18 years
0
   0.0%
Between 18 and 65 years
419
  83.5%
>=65 years
83
  16.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 502 participants
54  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 502 participants
Female
341
  67.9%
Male
161
  32.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 502 participants
502
1.Primary Outcome
Title Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 495
Mean (Standard Error)
Unit of Measure: points on a scale
0.9  (0.1)
2.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 475
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.3  (0.1)
3.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 450
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.5  (0.1)
4.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 428
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.4  (0.1)
5.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 396
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.5  (0.1)
6.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 377
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.4  (0.1)
7.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 353
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.5  (0.1)
8.Secondary Outcome
Title Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population/Intent to Treat
Arm/Group Title MYOBLOC Open Label Treatment
Hide Arm/Group Description:
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
Overall Number of Participants Analyzed 329
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.4  (0.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MYOBLOC Open Label Treatment
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MYOBLOC Open Label Treatment
Affected / at Risk (%) # Events
Total   133    
Cardiac disorders   
Acute Coronary Syndrome  1  8/502 (1.59%)  8
Acute Myocardial Infarction  1  1/502 (0.20%)  1
Angina  1  1/502 (0.20%)  1
Atrial Fibrillation  1  3/502 (0.60%)  3
AV Block 2nd Degree  1  1/502 (0.20%)  1
Coronary Artery Occlusion  1  1/502 (0.20%)  1
Bradycardia  1  1/502 (0.20%)  1
Myocardial infarction  1  2/502 (0.40%)  2
Palpitations  1  1/502 (0.20%)  1
Pericardial effusion  1  1/502 (0.20%)  1
sinus bradycardia  1  1/502 (0.20%)  1
tachycardia  1  1/502 (0.20%)  1
Ear and labyrinth disorders   
vertigo  1  1/502 (0.20%)  1
Endocrine disorders   
adrenal insufficiency  1  1/502 (0.20%)  1
Eye disorders   
eye haemorrhage  1  1/502 (0.20%)  1
Gastrointestinal disorders   
abdominal adhesions  1  1/502 (0.20%)  1
abdominal pain  1  2/502 (0.40%)  2
appendicitis  1  1/502 (0.20%)  1
celiac disease  1  1/502 (0.20%)  1
constipation  1  1/502 (0.20%)  1
diarrhea  1  1/502 (0.20%)  1
diverticulum  1  1/502 (0.20%)  1
dysphagia  1  1/502 (0.20%)  1
GI hemorrhage  1  3/502 (0.60%)  3
GI Reflux disease  1  1/502 (0.20%)  1
inguinal hernia  1  1/502 (0.20%)  1
inguinal hernia obsstructive  1  1/502 (0.20%)  1
nausea  1  1/502 (0.20%)  1
pancreatitis  1  1/502 (0.20%)  1
small intestine obstruction  1  1/502 (0.20%)  1
upper GI hemorrhage  1  1/502 (0.20%)  1
vomiting  1  2/502 (0.40%)  2
General disorders   
chest discomfort  1  1/502 (0.20%)  1
chest pain  1  4/502 (0.80%)  4
facial pain  1  1/502 (0.20%)  1
non cardiac chest pain  1  1/502 (0.20%)  1
pain  1  1/502 (0.20%)  1
Hepatobiliary disorders   
bile duct stone  1  1/502 (0.20%)  1
cholecystitis  1  1/502 (0.20%)  1
cholecystitis acute  1  1/502 (0.20%)  1
cholelithiasis  1  4/502 (0.80%)  4
hepatorenal syndrome  1  1/502 (0.20%)  1
jaundice  1  1/502 (0.20%)  1
Immune system disorders   
hypersensitivity  1  1/502 (0.20%)  1
Infections and infestations   
abdominal abscess  1  1/502 (0.20%)  1
appendicitis  1  1/502 (0.20%)  1
arthritis infective  1  1/502 (0.20%)  1
bartholin abscess  1  1/502 (0.20%)  1
GI norwalk virus  1  1/502 (0.20%)  1
GI viral  1  1/502 (0.20%)  1
haemophilis infection  1  1/502 (0.20%)  1
pelvic abscess  1  1/502 (0.20%)  1
pneumonia  1  2/502 (0.40%)  2
post operative abscess  1  1/502 (0.20%)  1
pyelonephritis  1  1/502 (0.20%)  1
sinusitis  1  1/502 (0.20%)  1
Upper Respiratory Infection (URI)  1  1/502 (0.20%)  1
Urinary Tract Infection (UTI)  1  1/502 (0.20%)  1
vaginal cellulitis  1  1/502 (0.20%)  1
drug toxicitiy  1  1/502 (0.20%)  1
Injury, poisoning and procedural complications   
accidental overdose  1  1/502 (0.20%)  1
brain contusion  1  1/502 (0.20%)  1
clavicle fracture  1  1/502 (0.20%)  1
fall  1  1/502 (0.20%)  1
hip fracture  1  3/502 (0.60%)  3
incisional hernia  1  2/502 (0.40%)  2
medication error  1  1/502 (0.20%)  1
multiple fractures  1  1/502 (0.20%)  1
overdose  1  20/502 (3.98%)  20
post procedural nausea  1  1/502 (0.20%)  1
post pocedural vomiting  1  1/502 (0.20%)  1
post operative ileus  1  1/502 (0.20%)  1
road traffic accident  1  4/502 (0.80%)  4
subdural hematoma  1  1/502 (0.20%)  1
upper limb fracture  1  1/502 (0.20%)  1
Investigations   
oxygen saturation decrease  1  1/502 (0.20%)  1
Metabolism and nutrition disorders   
dehydration  1  3/502 (0.60%)  3
hyperglycemia  1  1/502 (0.20%)  1
Musculoskeletal and connective tissue disorders   
arthralgia  1  1/502 (0.20%)  1
arthritis  1  1/502 (0.20%)  1
back disorder  1  1/502 (0.20%)  1
back pain  1  1/502 (0.20%)  1
intervebral disc degeneration  1  2/502 (0.40%)  2
intervebral disc protrusion  1  2/502 (0.40%)  2
muscle spasm  1  1/502 (0.20%)  1
musculoskeletal chest pain  1  1/502 (0.20%)  1
osteoarthritis  1  2/502 (0.40%)  2
rotator cuff syndrome  1  1/502 (0.20%)  1
spinal osteoarthritis  1  2/502 (0.40%)  2
torticollis  1  7/502 (1.39%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
basal cell carcinoma  1  4/502 (0.80%)  4
basosquamous carcinoma  1  1/502 (0.20%)  1
benign ovarian tumor  1  1/502 (0.20%)  1
bone neoplasm malignant  1  1/502 (0.20%)  1
brain neoplasm  1  1/502 (0.20%)  1
breast cancer  1  5/502 (1.00%)  5
keratocanthoma  1  1/502 (0.20%)  1
lung neoplasm malignant  1  1/502 (0.20%)  1
malignant neoplasm progression  1  1/502 (0.20%)  1
prostate cancer  1  2/502 (0.40%)  2
skin cancer  1  1/502 (0.20%)  1
squamous cell carcinoma  1  2/502 (0.40%)  2
squamous cell carcinoma of skin  1  1/502 (0.20%)  1
uterine leiomyoma  1  1/502 (0.20%)  1
vulval cancer  1  1/502 (0.20%)  1
Nervous system disorders   
Cerebrovascular Accident (CVA)  1  3/502 (0.60%)  3
cervical myelopathy  1  2/502 (0.40%)  2
convulsion  1  1/502 (0.20%)  1
Dementia  1  1/502 (0.20%)  1
Dizziness  1  2/502 (0.40%)  2
dystonia  1  1/502 (0.20%)  1
epilepsy  1  1/502 (0.20%)  1
intracranial aneurysm  1  1/502 (0.20%)  1
mutiple sclerosis  1  2/502 (0.40%)  2
syncope  1  1/502 (0.20%)  1
vertebrobasilar insufficiency  1  1/502 (0.20%)  1
Pregnancy, puerperium and perinatal conditions   
pregnancy  1  2/502 (0.40%)  2
Psychiatric disorders   
anxiety  1  1/502 (0.20%)  1
confusional state  1  1/502 (0.20%)  1
depression  1  3/502 (0.60%)  3
dissociative identity disorder  1  1/502 (0.20%)  1
major depression  1  1/502 (0.20%)  1
suicidal ideation  1  3/502 (0.60%)  3
Renal and urinary disorders   
bladder prolapse  1  1/502 (0.20%)  1
renal failure acute  1  1/502 (0.20%)  1
stress incontinence  1  1/502 (0.20%)  1
Reproductive system and breast disorders   
cystocele  1  1/502 (0.20%)  1
endometriosis  1  1/502 (0.20%)  1
menorrhagia  1  1/502 (0.20%)  1
ovarian cyst  1  1/502 (0.20%)  1
ovarian cyst rupture  1  1/502 (0.20%)  1
pelvic peritoneal adhesions  2  1/502 (0.20%)  1
rectocele  1  1/502 (0.20%)  1
atelectasis  1  2/502 (0.40%)  2
Respiratory, thoracic and mediastinal disorders   
choking  1  1/502 (0.20%)  1
Chronic Obstructive Pulmonary Disease  1  2/502 (0.40%)  2
dyspnea  1  2/502 (0.40%)  2
pulmonary embolism  1  2/502 (0.40%)  2
pulmonary edema  1  1/502 (0.20%)  1
sleep apnea syndrome  1  1/502 (0.20%)  1
Vascular disorders   
blood pressure fluctuation  1  1/502 (0.20%)  1
deep vein thrombosis  1  1/502 (0.20%)  1
haemotoma  1  1/502 (0.20%)  1
hypertension  1  3/502 (0.60%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MdDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
MYOBLOC Open Label Treatment
Affected / at Risk (%) # Events
Total   494    
Cardiac disorders   
Palpitations  1  11/502 (2.19%)  11
Ear and labyrinth disorders   
vertigo  1  18/502 (3.59%)  18
Endocrine disorders   
hypothyroidism  1  10/502 (1.99%)  10
Eye disorders   
cataract  1  10/502 (1.99%)  10
conjunctivitis  1  11/502 (2.19%)  11
dry eye  1  10/502 (1.99%)  10
vision blurred  1  12/502 (2.39%)  12
Gastrointestinal disorders   
abdominal pain  1  29/502 (5.78%)  29
abdominal pain upper  1  15/502 (2.99%)  15
constipation  1  43/502 (8.57%)  43
diarrhea  1  48/502 (9.56%)  48
dry mouth  1  348/502 (69.32%)  348
dyspepsia  1  48/502 (9.56%)  48
dysphagia  1  203/502 (40.44%)  203
GERD  1  42/502 (8.37%)  42
nausea  1  72/502 (14.34%)  72
toothache  2  10/502 (1.99%)  10
vomiting  1  30/502 (5.98%)  30
General disorders   
asthenia  1  12/502 (2.39%)  12
chest pain  1  28/502 (5.58%)  28
fatigue  1  51/502 (10.16%)  51
influenza like illness  1  25/502 (4.98%)  25
injection site pain  1  114/502 (22.71%)  114
injection site reaction  1  15/502 (2.99%)  15
edema peripheral  1  26/502 (5.18%)  26
pyrexia  1  12/502 (2.39%)  12
Infections and infestations   
bronchitis  1  50/502 (9.96%)  50
cystitis  1  18/502 (3.59%)  18
ear infection  1  10/502 (1.99%)  10
fungal infection  1  10/502 (1.99%)  10
GI viral  1  24/502 (4.78%)  24
herpes zoster  1  10/502 (1.99%)  10
influenza  1  84/502 (16.73%)  84
nasopharyngitis  1  110/502 (21.91%)  110
otitis media  1  18/502 (3.59%)  18
pneumonia  1  10/502 (1.99%)  10
sinusitis  1  68/502 (13.55%)  68
tooth abscess  1  14/502 (2.79%)  14
Upper Respiratory Infection  1  70/502 (13.94%)  70
Injury, poisoning and procedural complications   
joint sprain  1  15/502 (2.99%)  15
muscle sprain  1  10/502 (1.99%)  10
overdose  1  20/502 (3.98%)  20
procedural pain  1  25/502 (4.98%)  25
road traffic accident  1  16/502 (3.19%)  16
Investigations   
blood cholesterol increased  1  11/502 (2.19%)  11
Metabolism and nutrition disorders   
hypercholesterolemia  1  22/502 (4.38%)  22
Musculoskeletal and connective tissue disorders   
arthralgia  1  61/502 (12.15%)  61
arthritis  1  18/502 (3.59%)  18
back pain  1  77/502 (15.34%)  77
intervertebral disc degeneration  1  12/502 (2.39%)  12
interverterbral disc protrusion  1  11/502 (2.19%)  11
muscle spasm  1  77/502 (15.34%)  77
muscle tightness  1  13/502 (2.59%)  13
muscle weakness  1  41/502 (8.17%)  41
musculoskeletal weakness  1  20/502 (3.98%)  20
myalgia  1  25/502 (4.98%)  25
neck pain  1  32/502 (6.37%)  32
osteoarthritis  1  18/502 (3.59%)  18
pain in extremity  1  56/502 (11.16%)  56
rotator cuff syndrome  1  15/502 (2.99%)  15
shoulder pain  1  29/502 (5.78%)  29
tendonitis  1  15/502 (2.99%)  15
torticollis  1  170/502 (33.86%)  170
Nervous system disorders   
balance disorder  1  13/502 (2.59%)  13
carpal tunnel syndrome  1  11/502 (2.19%)  11
dizziness  1  68/502 (13.55%)  68
head titubation  1  29/502 (5.78%)  29
headache  1  117/502 (23.31%)  117
hypoaesthesia  1  46/502 (9.16%)  46
Migraine  1  22/502 (4.38%)  22
paraesthesia  1  31/502 (6.18%)  31
Somnolence  1  19/502 (3.78%)  19
syncope  1  12/502 (2.39%)  12
tremor  1  33/502 (6.57%)  33
Psychiatric disorders   
anxiety  1  36/502 (7.17%)  36
depression  1  67/502 (13.35%)  67
insomnia  1  46/502 (9.16%)  46
stress  1  12/502 (2.39%)  12
Respiratory, thoracic and mediastinal disorders   
choking  1  14/502 (2.79%)  14
cough  1  51/502 (10.16%)  51
dry throat  1  15/502 (2.99%)  15
dysphonia  1  10/502 (1.99%)  10
dyspnea  1  19/502 (3.78%)  19
nasal congestion  1  17/502 (3.39%)  17
pharangolaryngeal pain  1  36/502 (7.17%)  36
Skin and subcutaneous tissue disorders   
pruritis  1  10/502 (1.99%)  10
rash  1  31/502 (6.18%)  31
Vascular disorders   
hypertension  1  43/502 (8.57%)  43
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MdDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: US WorldMeds LLC ( Solstice Neurosciences )
ClinicalTrials.gov Identifier: NCT00702754     History of Changes
Other Study ID Numbers: 401CDNA
401CDNA
First Submitted: June 12, 2008
First Posted: June 20, 2008
Results First Submitted: May 12, 2009
Results First Posted: September 23, 2009
Last Update Posted: May 10, 2019