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NCT01753336 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT01753336: Completed Phase 3 study, sponsored by Ipsen.
NCT01753336 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753336, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Primary Outcome
Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subsca
Interventions
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01753336 record still lists
NCT01753336 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT01753336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01753336 about?
NCT01753336 is a clinical study titled "Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia". The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
What is the current status of trial NCT01753336?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2013-03. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01753336?
The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01753336?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01753336's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 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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