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NCT01457352 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
A Phase 3 study, sponsored by Sun Pharma Advanced Research Company Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 392
- Enrollment target
NCT01457352: Completed Phase 3 study, sponsored by Sun Pharma Advanced Research Company Limited.
NCT01457352 is a Phase 3 study that has completed, run by Sun Pharma Advanced Research Company Limited. The registered enrollment target is 392 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457352, a Phase 3 study, has completed, sponsored by Sun Pharma Advanced Research Company Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 392 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
Primary Outcome
Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (globa
Interventions
- DRUG SPARC0921
- DRUG Placebo0921
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2012-11-14 |
| Est. Completion | 2017-08-25 |
| Phase | Phase 3 |
What the finished NCT01457352 record still lists
NCT01457352 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which SPARC0921 is the first listed.
NCT01457352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01457352 about?
NCT01457352 is a clinical study titled "Efficacy and Safety of SPARC0921 in Subjects With Spasticity". The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
What is the current status of trial NCT01457352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 392 participants. The study started on 2012-11-14. Estimated completion is 2017-08-25.
What interventions are being tested in trial NCT01457352?
The interventions under investigation include: SPARC0921 (DRUG), Placebo0921 (DRUG).
Who is sponsoring clinical trial NCT01457352?
This trial is sponsored by Sun Pharma Advanced Research Company Limited, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01457352's enrollment target sits among peer trials
392 967th of 2000 higher than 1,033 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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