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Trial record 1 of 1 for:    NCT01797185
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Safety Study of SPARC1104

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ClinicalTrials.gov Identifier: NCT01797185
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : March 12, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Spasticity
Interventions Drug: SPARC1104 modified dose regimen I
Drug: SPARC1104 modified dose regimen II
Drug: SPARC1104 modified dose regimen III
Enrollment 375
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Hide Arm/Group Description Subjects who completed Part 3 of Study CLR_09_21 Dose: One or two capsules once daily Subjects who are on Dose regimen I of SPARC0921 at entry. Dose: One or two capsules once daily Subjects Entering the Trial with no Prior Treatment with SPARC0921 Dose: One or two capsules once daily
Period Title: Overall Study
Started 162 163 50
Completed 134 125 38
Not Completed 28 38 12
Reason Not Completed
Adverse Event             5             15             6
Withdrawal by Subject             6             9             5
Site terminated             8             4             0
Lost to Follow-up             2             6             1
Withdrawn per sponsor             5             0             0
Physician Decision             1             3             0
Protocol Violation             1             1             0
Arm/Group Title SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3 Total
Hide Arm/Group Description Subjects who completed Study CLR_09_21 Subjects who are on Dose regimen I of SPARC0921 at entry Subjects Entering the Trial with no Prior Treatment with SPARC0921 Total of all reporting groups
Overall Number of Baseline Participants 162 163 50 375
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 163 participants 50 participants 375 participants
51.7  (9.56) 52.9  (9.77) 51.3  (11.55) 52.2  (9.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 163 participants 50 participants 375 participants
Female
119
  73.5%
116
  71.2%
29
  58.0%
264
  70.4%
Male
43
  26.5%
47
  28.8%
21
  42.0%
111
  29.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 163 participants 50 participants 375 participants
Hispanic or Latino
7
   4.3%
5
   3.1%
3
   6.0%
15
   4.0%
Not Hispanic or Latino
155
  95.7%
158
  96.9%
47
  94.0%
360
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 163 participants 50 participants 375 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.3%
Asian
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
28
  17.3%
19
  11.7%
5
  10.0%
52
  13.9%
White
132
  81.5%
139
  85.3%
44
  88.0%
315
  84.0%
More than one race
1
   0.6%
4
   2.5%
1
   2.0%
6
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Adverse Events
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Subject who received at least one dose of study treatment
Arm/Group Title SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Hide Arm/Group Description:
Subjects who completed Study CLR_09_21
Subjects who are on Dose regimen I of SPARC0921 at entry
Subjects Entering the Trial with no Prior Treatment with SPARC0921
Overall Number of Participants Analyzed 162 163 50
Measure Type: Number
Unit of Measure: Count of participants
129 150 44
Time Frame Week 26
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Hide Arm/Group Description Subjects who completed Study CLR_09_21 Subjects who are on Dose regimen I of SPARC0921 at entry Subjects Entering the Trial with no Prior Treatment with SPARC0921
All-Cause Mortality
SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)   0/163 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/162 (18.52%)   40/163 (24.54%)   6/50 (12.00%) 
Cardiac disorders       
Acute coronary syndrome   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Angina pectoris   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Atrial fibrillation   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Atrial flutter   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Myocardial infarction   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Stress cardiomyopathy   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Endocrine disorders       
Goitre   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Gastrointestinal disorders       
Abdominal hernia   1/162 (0.62%)  1/163 (0.61%)  0/50 (0.00%) 
Abdominal pain   0/162 (0.00%)  1/163 (0.61%)  1/50 (2.00%) 
Acquired oesophageal web   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Constipation   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Gastrooesophageal reflux disease   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Nausea   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Pancreatitis   0/162 (0.00%)  0/163 (0.00%)  1/50 (2.00%) 
Vomiting   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
General disorders       
Asthenia   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Chest pain   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Pyrexia   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis   2/162 (1.23%)  1/163 (0.61%)  0/50 (0.00%) 
Cholecystitis acute   0/162 (0.00%)  2/163 (1.23%)  0/50 (0.00%) 
Biliary dyskinesia   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Ankle fracture   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Femur fracture   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Fibula fracture   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Hip fracture   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Rib fracture   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Investigations       
Liver function test abnormal   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Metabolism and nutrition disorders       
Dehydration   2/162 (1.23%)  1/163 (0.61%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis   2/162 (1.23%)  1/163 (0.61%)  2/50 (4.00%) 
Arthralgia   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Arthritis   0/162 (0.00%)  0/163 (0.00%)  1/50 (2.00%) 
Intervertebral disc degeneration   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Intervertebral disc protrusion   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Muscular weakness   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Pain in extremity   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Nervous system disorders       
Multiple sclerosis relapse   4/162 (2.47%)  5/163 (3.07%)  0/50 (0.00%) 
Syncope   1/162 (0.62%)  2/163 (1.23%)  0/50 (0.00%) 
Partial seizures   1/162 (0.62%)  1/163 (0.61%)  0/50 (0.00%) 
Aphasia   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Complex partial seizures   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Convulsion   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Encephalopathy   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Lumbar radiculopathy   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Migraine   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Transient ischaemic attack   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Trigeminal neuralgia   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Psychiatric disorders       
Mental status changes   3/162 (1.85%)  5/163 (3.07%)  0/50 (0.00%) 
Delirium   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Psychotic disorder   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Stress   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Suicide attempt   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis   1/162 (0.62%)  0/163 (0.00%)  1/50 (2.00%) 
Renal failure acute   2/162 (1.23%)  0/163 (0.00%)  0/50 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Rectocele   1/162 (0.62%)  0/163 (0.00%)  0/50 (0.00%) 
Testicular torsion   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism   2/162 (1.23%)  0/163 (0.00%)  0/50 (0.00%) 
Asthma   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Respiratory failure   0/162 (0.00%)  1/163 (0.61%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders       
Stasis dermatitis   0/162 (0.00%)  0/163 (0.00%)  1/50 (2.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPARC1104 Group 1 SPARC1104 Group 2 SPARC1104 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   129/162 (79.63%)   150/163 (92.02%)   44/50 (88.00%) 
Gastrointestinal disorders       
Nausea   19/162 (11.73%)  24/163 (14.72%)  7/50 (14.00%) 
Diarrhoea   16/162 (9.88%)  14/163 (8.59%)  5/50 (10.00%) 
Vomiting   12/162 (7.41%)  7/163 (4.29%)  2/50 (4.00%) 
General disorders       
Fatigue   16/162 (9.88%)  25/163 (15.34%)  5/50 (10.00%) 
Asthenia   9/162 (5.56%)  9/163 (5.52%)  2/50 (4.00%) 
Oedema peripheral   8/162 (4.94%)  11/163 (6.75%)  1/50 (2.00%) 
Infections and infestations       
Nasopharyngitis   13/162 (8.02%)  23/163 (14.11%)  8/50 (16.00%) 
Upper respiratory tract infection   11/162 (6.79%)  11/163 (6.75%)  2/50 (4.00%) 
Sinusitis   10/162 (6.17%)  12/163 (7.36%)  0/50 (0.00%) 
Injury, poisoning and procedural complications       
Fall   20/162 (12.35%)  22/163 (13.50%)  2/50 (4.00%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms   14/162 (8.64%)  35/163 (21.47%)  4/50 (8.00%) 
Back pain   17/162 (10.49%)  26/163 (15.95%)  4/50 (8.00%) 
Muscular weakness   14/162 (8.64%)  23/163 (14.11%)  5/50 (10.00%) 
Pain in extremity   16/162 (9.88%)  20/163 (12.27%)  5/50 (10.00%) 
Arthralgia   16/162 (9.88%)  19/163 (11.66%)  4/50 (8.00%) 
Musculoskeletal pain   9/162 (5.56%)  10/163 (6.13%)  1/50 (2.00%) 
Musculoskeletal stiffness   9/162 (5.56%)  10/163 (6.13%)  0/50 (0.00%) 
Nervous system disorders       
Headache   26/162 (16.05%)  31/163 (19.02%)  11/50 (22.00%) 
Multiple sclerosis relapse   29/162 (17.90%)  30/163 (18.40%)  7/50 (14.00%) 
Muscle spasticity   24/162 (14.81%)  32/163 (19.63%)  9/50 (18.00%) 
Urinary tract infection   32/162 (19.75%)  21/163 (12.88%)  5/50 (10.00%) 
Dizziness   11/162 (6.79%)  22/163 (13.50%)  11/50 (22.00%) 
Hypoaesthesia   7/162 (4.32%)  9/163 (5.52%)  5/50 (10.00%) 
Psychiatric disorders       
Insomnia   10/162 (6.17%)  15/163 (9.20%)  2/50 (4.00%) 
Depression   8/162 (4.94%)  8/163 (4.91%)  3/50 (6.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough   5/162 (3.09%)  22/163 (13.50%)  2/50 (4.00%) 
Bronchitis   7/162 (4.32%)  16/163 (9.82%)  4/50 (8.00%) 
Indicates events were collected by systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SPARC
Organization: Sun Pharma Advanced Research Company Limited
Phone: +912266455645
EMail: Clinical.Trials@Sparcmail.com
Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01797185    
Other Study ID Numbers: CLR_11_04
First Submitted: February 16, 2013
First Posted: February 22, 2013
Results First Submitted: November 15, 2018
Results First Posted: March 12, 2019
Last Update Posted: May 3, 2019