TorticollisPhase 4NCT01384214
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
A Phase 4 study testing botulinum toxin Type A in people with Torticollis, run by Allergan at 1 site in Croatia.
Trial summary
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Torticollis
- What is being tested?
- botulinum toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cervical dystonia
- Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
- In need of additional botulinum toxin Type A injections
Who cannot join
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol or alcohol for cervical dystonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
- Conditions
- Torticollis
- Being tested
- botulinum toxin Type A
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called Dysport®
750 U at Visit 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | botulinum toxin Type A Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
Measured: Baseline, Week 2
Secondary outcomes (5)
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
Measured: Week 4
Physician Assessment of Cervical Dystonia Severity
Measured: Week 4
Global Assessment of Benefit by Physician
Measured: Week 4
Global Assessment of Benefit by Patient
Measured: Week 4
Patient Visual Analog Assessment of Pain
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorticollisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384214
- Sponsor's protocol ID
- MedAff-BTX-0716
- Status last verified
- Jun 2011
- First submitted
- 27 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT01384214
- Acronym / sponsor ID
- MedAff-BTX-0716
- Conditions
- Torticollis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: botulinum toxin Type Abotulinum toxin Type A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with cervical dystonia
- Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
- In need of additional botulinum toxin Type A injections
Key exclusion criteria (2 listed)
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol or alcohol for cervical dystonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Type AAlso: Dysport®750 U at Visit 1 | Biological | 1 |
Primary outcome
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
Time frame: Baseline, Week 2
5 secondary outcomes
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
Time frame: Week 4
Physician Assessment of Cervical Dystonia Severity
Time frame: Week 4
Global Assessment of Benefit by Physician
Time frame: Week 4
Global Assessment of Benefit by Patient
Time frame: Week 4
Patient Visual Analog Assessment of Pain
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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An Observational Study of Individuals With Isolated Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin Type A in people with Torticollis, run by Allergan at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE) (time frame: Baseline, Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.