Spasmodic TorticollisPhase 1NCT00549341
PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
A Phase 1 study testing Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin and Physiologic saline in people with Spasmodic Torticollis, run by Mentor Worldwide, LLC at 1 site in United States.
Trial summary
The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Spasmodic Torticollis
- What is being tested?
- Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin and Physiologic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2009
- Phase
- Phase 1
- 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
- Diagnosis of torticollis with noticeable symptoms for at least 6 months
- Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria)
Who cannot join
- Diagnosis of isolated anterocollis
- Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis
- Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides
- Any illness that is considered by the Investigator to make the subject an inappropriate candidate
- Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening
- Pre-existing dysphagia
Show all 11Show fewer
- History of active autoimmune disease
- Exposure to botulinum toxin based pharmaceutical within 3 months prior to screening
- History of primary non-response or secondary resistance with prior exposure to botulinum based pharmaceuticals
- History of chemotherapy/radiation for malignant disease within 24 months
- Any investigational drug/device during the 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Mentor Worldwide, LLC
Santa Barbara, California, 93111
About this study
Official title: A Phase I, Single-dose, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety of PurTox for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia and to Explore Dose-associated Efficacy
The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.
- Conditions
- Spasmodic Torticollis
- Being tested
- Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin, Physiologic saline
- Keywords
- Torticollis, Cervical Dystonia
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentor Purified Toxin, Botulinum Toxn Type A, Purified NeurotoxinDrug
100U vials, doses ranged from 50U-200U, single injection.
Physiologic salineOther
Single injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin |
| 2 | Placebo comparator | Not described Receives: Other: Physiologic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of significant drug related adverse effects
Measured: Post-injection
Secondary outcomes (1)
Decrease in symptom severity (TWSTRS)
Measured: 30 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startMay 2006
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasmodic 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolyn Austin, Study director, Mentor Worldwide, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549341
- Sponsor's protocol ID
- PT-ST-01
- Status last verified
- Mar 2016
- First submitted
- 23 Oct 2007
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-dose, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety of PurTox for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia and to Explore Dose-associated Efficacy
- ClinicalTrials.gov ID
- NCT00549341
- Acronym / sponsor ID
- PT-ST-01
- Conditions
- Spasmodic Torticollis
- Keywords
- Torticollis, Cervical Dystonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Oct 2007 (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 safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin |
| 2 | Placebo comparator | Other: Physiologic saline |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of torticollis with noticeable symptoms for at least 6 months
- Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria)
Key exclusion criteria (11 listed)
- Diagnosis of isolated anterocollis
- Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis
- Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides
- Any illness that is considered by the Investigator to make the subject an inappropriate candidate
- Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening
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 |
|---|---|---|
| Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin100U vials, doses ranged from 50U-200U, single injection. | Drug | 1 |
| Physiologic salineSingle injection. | Other | 2 |
Primary outcome
Absence of significant drug related adverse effects
Time frame: Post-injection
1 secondary outcome
Decrease in symptom severity (TWSTRS)
Time frame: 30 days post-injection
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 Mar 2016.
Related trials for Spasmodic Torticollis
Enrolling by invitationPhase 2
Accelerating TMS for Cervical Dystonia
Isolated Cervical Dystonia
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
Recruiting
Noninvasive Brain Stimulation for Cervical Dystonia
Cervical Dystonia
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.
Carolyn Austin study director
Mentor Worldwide, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin and Physiologic saline in people with Spasmodic Torticollis, run by Mentor Worldwide, LLC at 1 site 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 2 inclusion and 11 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 Mar 2016. 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 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Absence of significant drug related adverse effects (time frame: Post-injection). 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 Mar 2016.