PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
This study has been completed.
Sponsor:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00549341
First received: October 23, 2007
Last updated: September 1, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spasmodic Torticollis |
Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin Other: Physiologic saline |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mentor Worldwide, LLC:
Primary Outcome Measures:
- Absence of significant drug related adverse effects [ Time Frame: Post-injection ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Decrease in symptom severity (TWSTRS) [ Time Frame: 30 days post-injection ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | May 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
100U vials, doses ranged from 50U-200U, single injection.
|
| Placebo Comparator: 2 |
Other: Physiologic saline
Single injection.
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mentor Worldwide, LLC |
| ClinicalTrials.gov Identifier: | NCT00549341 History of Changes |
| Other Study ID Numbers: | PT-ST-01 |
| Study First Received: | October 23, 2007 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mentor Worldwide, LLC:
|
Torticollis Cervical Dystonia |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013