Trial Outcomes & Findings for Safety Study of SPARC1104 (NCT NCT01797185)
NCT ID: NCT01797185
Last Updated: 2019-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
52 weeks
Results posted on
2019-05-03
Participant Flow
Participant milestones
| Measure |
SPARC1104 Group 1
Subjects who completed Part 3 of Study CLR\_09\_21 Dose: One or two capsules once daily
|
SPARC1104 Group 2
Subjects who are on Dose regimen I of SPARC0921 at entry. Dose: One or two capsules once daily
|
SPARC1104 Group 3
Subjects Entering the Trial with no Prior Treatment with SPARC0921 Dose: One or two capsules once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
162
|
163
|
50
|
|
Overall Study
COMPLETED
|
134
|
125
|
38
|
|
Overall Study
NOT COMPLETED
|
28
|
38
|
12
|
Reasons for withdrawal
| Measure |
SPARC1104 Group 1
Subjects who completed Part 3 of Study CLR\_09\_21 Dose: One or two capsules once daily
|
SPARC1104 Group 2
Subjects who are on Dose regimen I of SPARC0921 at entry. Dose: One or two capsules once daily
|
SPARC1104 Group 3
Subjects Entering the Trial with no Prior Treatment with SPARC0921 Dose: One or two capsules once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
15
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
5
|
|
Overall Study
Site terminated
|
8
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
1
|
|
Overall Study
Withdrawn per sponsor
|
5
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
Baseline Characteristics
Safety Study of SPARC1104
Baseline characteristics by cohort
| Measure |
SPARC1104 Group 1
n=162 Participants
Subjects who completed Study CLR\_09\_21
|
SPARC1104 Group 2
n=163 Participants
Subjects who are on Dose regimen I of SPARC0921 at entry
|
SPARC1104 Group 3
n=50 Participants
Subjects Entering the Trial with no Prior Treatment with SPARC0921
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 9.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
315 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety population: Subject who received at least one dose of study treatment
Outcome measures
| Measure |
SPARC1104 Group 1
n=162 Participants
Subjects who completed Study CLR\_09\_21
|
SPARC1104 Group 2
n=163 Participants
Subjects who are on Dose regimen I of SPARC0921 at entry
|
SPARC1104 Group 3
n=50 Participants
Subjects Entering the Trial with no Prior Treatment with SPARC0921
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
|
129 Count of participants
|
150 Count of participants
|
44 Count of participants
|
Adverse Events
SPARC1104 Group 1
Serious events: 30 serious events
Other events: 129 other events
Deaths: 0 deaths
SPARC1104 Group 2
Serious events: 40 serious events
Other events: 150 other events
Deaths: 0 deaths
SPARC1104 Group 3
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPARC1104 Group 1
n=162 participants at risk
Subjects who completed Study CLR\_09\_21
|
SPARC1104 Group 2
n=163 participants at risk
Subjects who are on Dose regimen I of SPARC0921 at entry
|
SPARC1104 Group 3
n=50 participants at risk
Subjects Entering the Trial with no Prior Treatment with SPARC0921
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Cardiac disorders
Angina pectoris
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Cardiac disorders
Atrial flutter
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Endocrine disorders
Goitre
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.62%
1/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/162 • Week 26
|
0.00%
0/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
2/162 • Week 26
|
0.61%
1/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/162 • Week 26
|
0.00%
0/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Multiple sclerosis relapse
|
2.5%
4/162 • Week 26
|
3.1%
5/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Syncope
|
0.62%
1/162 • Week 26
|
1.2%
2/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Partial seizures
|
0.62%
1/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Aphasia
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Convulsion
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Migraine
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Transient ischaemic attack
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Psychiatric disorders
Mental status changes
|
1.9%
3/162 • Week 26
|
3.1%
5/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Psychiatric disorders
Delirium
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Psychiatric disorders
Psychotic disorder
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Psychiatric disorders
Stress
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
2/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Reproductive system and breast disorders
Rectocele
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/162 • Week 26
|
0.00%
0/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Investigations
Liver function test abnormal
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
General disorders
Asthenia
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
General disorders
Chest pain
|
0.00%
0/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
General disorders
Pyrexia
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
2/162 • Week 26
|
0.61%
1/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/162 • Week 26
|
1.2%
2/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.62%
1/162 • Week 26
|
0.00%
0/163 • Week 26
|
0.00%
0/50 • Week 26
|
Other adverse events
| Measure |
SPARC1104 Group 1
n=162 participants at risk
Subjects who completed Study CLR\_09\_21
|
SPARC1104 Group 2
n=163 participants at risk
Subjects who are on Dose regimen I of SPARC0921 at entry
|
SPARC1104 Group 3
n=50 participants at risk
Subjects Entering the Trial with no Prior Treatment with SPARC0921
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
16.0%
26/162 • Week 26
|
19.0%
31/163 • Week 26
|
22.0%
11/50 • Week 26
|
|
Nervous system disorders
Multiple sclerosis relapse
|
17.9%
29/162 • Week 26
|
18.4%
30/163 • Week 26
|
14.0%
7/50 • Week 26
|
|
Nervous system disorders
Muscle spasticity
|
14.8%
24/162 • Week 26
|
19.6%
32/163 • Week 26
|
18.0%
9/50 • Week 26
|
|
Nervous system disorders
Urinary tract infection
|
19.8%
32/162 • Week 26
|
12.9%
21/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.6%
14/162 • Week 26
|
21.5%
35/163 • Week 26
|
8.0%
4/50 • Week 26
|
|
Gastrointestinal disorders
Nausea
|
11.7%
19/162 • Week 26
|
14.7%
24/163 • Week 26
|
14.0%
7/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
17/162 • Week 26
|
16.0%
26/163 • Week 26
|
8.0%
4/50 • Week 26
|
|
General disorders
Fatigue
|
9.9%
16/162 • Week 26
|
15.3%
25/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Nervous system disorders
Dizziness
|
6.8%
11/162 • Week 26
|
13.5%
22/163 • Week 26
|
22.0%
11/50 • Week 26
|
|
Injury, poisoning and procedural complications
Fall
|
12.3%
20/162 • Week 26
|
13.5%
22/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
13/162 • Week 26
|
14.1%
23/163 • Week 26
|
16.0%
8/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.6%
14/162 • Week 26
|
14.1%
23/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
16/162 • Week 26
|
12.3%
20/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
16/162 • Week 26
|
11.7%
19/163 • Week 26
|
8.0%
4/50 • Week 26
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
16/162 • Week 26
|
8.6%
14/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
5/162 • Week 26
|
13.5%
22/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.3%
7/162 • Week 26
|
9.8%
16/163 • Week 26
|
8.0%
4/50 • Week 26
|
|
Psychiatric disorders
Insomnia
|
6.2%
10/162 • Week 26
|
9.2%
15/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
11/162 • Week 26
|
6.7%
11/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Infections and infestations
Sinusitis
|
6.2%
10/162 • Week 26
|
7.4%
12/163 • Week 26
|
0.00%
0/50 • Week 26
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
7/162 • Week 26
|
5.5%
9/163 • Week 26
|
10.0%
5/50 • Week 26
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
12/162 • Week 26
|
4.3%
7/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
General disorders
Asthenia
|
5.6%
9/162 • Week 26
|
5.5%
9/163 • Week 26
|
4.0%
2/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
9/162 • Week 26
|
6.1%
10/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
General disorders
Oedema peripheral
|
4.9%
8/162 • Week 26
|
6.7%
11/163 • Week 26
|
2.0%
1/50 • Week 26
|
|
Psychiatric disorders
Depression
|
4.9%
8/162 • Week 26
|
4.9%
8/163 • Week 26
|
6.0%
3/50 • Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
9/162 • Week 26
|
6.1%
10/163 • Week 26
|
0.00%
0/50 • Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER