Torticollis (Spasmodic)Phase 2NCT02706795
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
A Phase 2 study testing DaxibotulinumtoxinA in people with Torticollis (Spasmodic), run by Revance Therapeutics, Inc. at 13 sites in United States.
Trial summary
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Torticollis (Spasmodic)
- What is being tested?
- DaxibotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2015to 17 Jul 2017
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for isolated cervical dystonia
- Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15
- Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study
Who cannot join
- Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia
- Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia
- Neurological abnormalities other than cervical dystonia
- History of severe dysphagia or aspiration, or current clinically significant swallowing disorder
- Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen
- Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spinal deformity
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- Profound atrophy of cervical musculature
- Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Suboptimal efficacy response to any prior botulinum toxin type A product, when a previous treatment produced more optimal therapeutic response, as judged subjectively by the Investigator
- Previous treatment with any botulinum toxin product for any condition within the 6 months prior to Screening and during the study; presence of any blood coagulation disorder; or on anticoagulation treatment with international normalized ratio (INR) > 3.5
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University
Atlanta, Georgia, 30329
The NeuroMedical Center Clinic
Baton Rouge, Louisiana, 70810
Rush University Medical Center
Chicago, Illinois, 60612
Riverhills Healthcare, Inc.
Cincinnati, Ohio, 45212
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, 92708
University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, 32607
Parkinson's Disease Center and Movement Disorder Clinic
Houston, Texas, 77030
Precision Research Organization
Miami Lakes, Florida, 33016
Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211
Coastal Neurology
Port Royal, South Carolina, 29935
University of South Florida
Tampa, Florida, 33613
Wake forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
- Conditions
- Torticollis (Spasmodic)
- Being tested
- DaxibotulinumtoxinA
- Keywords
- Cervical dystonia, Spasmodic torticollis
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxibotulinumtoxinABiological
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
| Study group | Role | What they receive |
|---|---|---|
| daxibotulinumtoxinA (DAXI) for injection | Experimental | DAXI for injection Receives: Biological: DaxibotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
Measured: Week 4
Secondary outcomes (6)
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score
Measured: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)
Measured: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment
Measured: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment
Measured: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)
Measured: Post-treatment: Weeks 4, 6, 12, 16, 20, 24
Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)
Measured: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startSep 2015
- Primary completion7 Dec 2016
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Torticollis (Spasmodic)Studies 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 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nubia Kaba, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706795
- Sponsor's protocol ID
- RT002-CL005
- Status last verified
- Oct 2019
- First submitted
- 8 Mar 2016
- Last updated
- 6 Nov 2019
- Results posted
- No
Publications
Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun.
PubMed 30009213
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT02706795
- Acronym / sponsor ID
- RT002-CL005
- Conditions
- Torticollis (Spasmodic)
- Keywords
- Cervical dystonia, Spasmodic torticollis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 11 Mar 2016 (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.
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| daxibotulinumtoxinA (DAXI) for injection | Experimental | Biological: DaxibotulinumtoxinADAXI for injection |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets diagnostic criteria for isolated cervical dystonia
- Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15
- Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study
Key exclusion criteria (10 listed)
- Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia
- Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia
- Neurological abnormalities other than cervical dystonia
- History of severe dysphagia or aspiration, or current clinically significant swallowing disorder
- Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen
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 |
|---|---|---|
| DaxibotulinumtoxinALow, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study | Biological | daxibotulinumtoxinA (DAXI) for injection |
Primary outcome
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
Time frame: Week 4
6 secondary outcomes
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment
Time frame: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)
Time frame: Post-treatment: Weeks 4, 6, 12, 16, 20, 24
Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
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 6 Nov 2019.
- Derived from this study: PubMed 30009213Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun.
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.
Nubia Kaba study director
Sponsor GmbH
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DaxibotulinumtoxinA in people with Torticollis (Spasmodic), run by Revance Therapeutics, Inc. at 13 sites in United States.
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 10 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706795, which also lists 1 linked publication.
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 6 Nov 2019.