Efficacy Study of Botox to Treat Neuropathic Pain
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Purpose
Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia Nerve Trauma |
Drug: botulinum toxin A and saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Placebo-Controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia |
- Self-reported pain (numerical scales) on patients diaries [ Time Frame: prospective ]
- mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness [ Time Frame: prospective ]
| Enrollment: | 29 |
| Study Start Date: | June 2004 |
| Study Completion Date: | March 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
active treatment arm
|
Drug: botulinum toxin A and saline |
| Placebo Comparator: 2 | Drug: botulinum toxin A and saline |
Detailed Description:
The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
- limited area of pain
- mechanical allodynia in the painful area
Exclusion Criteria:
- contraindication to BTXA formulation
- coagulation disorders
- another painful condition
- current major depression
- history of drug or alcohol abuse
- compensation claim or litigation
- facial neuropathic pain
Contacts and Locations| France | |
| Hôpital Ambroise Paré, AP-HP | |
| Boulogne-billancourt, France, 92100f | |
| Study Director: | Didier BOUHASSIRA, MD, PHD | INSERM U 792 |
| Study Chair: | Danièle RANOUX, MD | hôpital de Limoges (FRANCE) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00527202 History of Changes |
| Other Study ID Numbers: | BTXneurop-1 |
| Study First Received: | September 7, 2007 |
| Last Updated: | September 7, 2007 |
| Health Authority: | France: Direction Générale de la Santé |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms 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