Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea (ALS-TOX)
This study is currently recruiting participants.
Verified March 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01551940
First received: March 9, 2012
Last updated: March 12, 2012
Last verified: March 2012
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Purpose
Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.
| Condition | Intervention | Phase |
|---|---|---|
|
Sialorrhea Amyotrophic Lateral Sclerosis |
Drug: Botox injection Drug: Placebo injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS) |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Improvement of the functional embarrassment provoked by sialorrhea [ Time Frame: 1 month after the injection ] [ Designated as safety issue: Yes ]Demonstrate after the injection of botulinum toxin type A an improvement of at least 25 % of the functional embarrassment provoked by sialorrhea in the ALS patient, evaluated with a horizontal visual analogue scale (VAS).
Secondary Outcome Measures:
- Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver by a horizontal visual analogue scale.
- Improvement of the value of the hypersalivation item in ALSFRS-R scale [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the value of the hypersalivation item in ALSFRS-R scale.
- Decrease of the score of severity and frequency of the drooling rating scale [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the score of severity and frequency of the drooling rating scale
- Decrease of the cotton roll weight [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]
Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the cotton roll weight.
Cotton rolls weight: production and quantity of saliva are verified by placing dental cotton rolls during 3 minutes in the mouth of the patient and by comparing the weight of rolls dry and soaked with saliva.
- Decrease of the number of paper handkerchiefs used [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the number of paper handkerchiefs used. We ask the patient to count the number of handkerchiefs used a day.
- Modification of the speech evaluation [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin typeA, a modification of the speech evaluation (evaluation realized by speech evaluator)
- Improvement of the quality of life [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the quality of life. Scale to estimate quality of life (ALSAQ-40), usually used with the patients affected by ALS
- Description of patient cohort after the first injection [ Time Frame: 6 months after the injection ] [ Designated as safety issue: No ]Describe cohort after the first injection: evolution of scores for every patient among Day0 and Month1, delay of appearance of the efficiency, the duration of effect of the treatment, the side effects, the modification of the consistency of the saliva and the possible necessity for re-injecting the patient at 3 months of follow-up.
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botox
100 UI of botulinum toxin type A (Botox®) diluted in 2.2 ml of NaCl 0.9 %
|
Drug: Botox injection
Local ultrasound-guided bilateral injection of botulinum toxin type A in parotid (35 UI/gland) and submandibular (15 UI/gland) glands.
|
|
Placebo Comparator: Placebo
NaCl 0.9 %
|
Drug: Placebo injection
A local ultrasound-guided bilateral injection of placebo (NaCl 0.9 %) in parotid (0.7 ml/gland) and submandibular (0.3 ml/gland) glands.
|
Detailed Description:
The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Obtaining of a written consent after information
- Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases
- Patient having a follow-up in an ALS center
- Sialorrhea with VAS functional embarrassment > or equal at 50/100.
- Patient beneficiary of Social Security regime
Exclusion Criteria:
- Evolving disease associated with predictable survival < 1 month
- Patient having previously received an injection of botulinum toxin in the salivary glands
- Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)
- Patient having benefited from radiotherapy or from surgery on the salivary glands
- Behavioral problems, dementia or other psychiatric problems
- Myasthenia
- Known Pregnancy or absence of contraception recognized as effective, breast feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551940
Contacts
| Contact: Nadia Vandenberghe, MD | 472 11 90 65 ext +33 | nadia.vandenberghe@chu-lyon.fr |
| Contact: Sylvie Bin, MD | 472 11 54 38 ext +33 | sylvie.bin@chu-lyon.fr |
Locations
| France | |
| Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers | Recruiting |
| Angers cedex 9, France, 49933 | |
| Contact: Guillaume NICOLAS, MD | |
| Principal Investigator: Guillaume NICOLAS, MD | |
| Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon | Recruiting |
| Bron, France, 69677 | |
| Contact: Nadia Vandenberghe, MD 472 11 90 65 ext +33 nadia.vandenberghe@chu-lyon.fr | |
| Principal Investigator: Nadia Vandenberghe, MD | |
| Service de Neurologie Vastel, Hôpital Côte de Nacre, CHU de Caen | Recruiting |
| Caen cedex 9, France, 14033 | |
| Contact: Fausto VIADER, MD, PhD | |
| Principal Investigator: Fausto VIADER, MD, PhD | |
| Service de Neurologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand | Recruiting |
| Clermont-Ferrand cedex 1, France, 63003 | |
| Contact: Pierre CLAVELOU, MD, PhD | |
| Principal Investigator: Pierre CLAVELOU, MD, PhD | |
| Service de Neurologie, Hôpital Dupuytren, CHU de Limoges | Recruiting |
| Limoges, France, 87042 | |
| Contact: Philippe COURATIER, MD, PhD | |
| Principal Investigator: Philippe COURATIER, MD, PhD | |
| Service de Neurologie, Hôpital de la Timone, CHU de Marseille | Recruiting |
| Marseille cedex 5, France, 13385 | |
| Contact: Jean POUGET, MD, PhD | |
| Principal Investigator: Jean POUGET, MD, PhD | |
| Service de Neurologie, Hôpital Central, CHU de Nancy | Recruiting |
| Nancy, France, 54035 | |
| Contact: Sophie PITTION VOUYOVITCH, MD | |
| Principal Investigator: Sophie PITTION VOUYOVITCH, MD | |
| Centre de Référence maladies Neuromusculaires, Service de Médecine Physique et Réadaptation, Hôpital de l'Archet 1, CHU de Nice | Recruiting |
| Nice cedex 3, France, 06202 | |
| Contact: Claude DESNUELLE, MD, PhD | |
| Principal Investigator: Claude DESNUELLE, MD, PhD | |
| Fédération des Maladies du Système Nerveux, Groupement Hospitalier Pitié Salpêtrière, AP-HP | Recruiting |
| Paris cedex 13, France, 75651 | |
| Contact: François SALACHAS, MD | |
| Principal Investigator: François SALACHAS, MD | |
| Service de Neurologie, CHU de Saint-Etienne | Recruiting |
| Saint-Etienne cedex 2, France, 42055 | |
| Contact: Jean-Christophe ANTOINE, MD, PhD | |
| Principal Investigator: Jean-Christophe ANTOINE, MD, PhD | |
| Département de Neurologie, Hôpital Civil, CHRU de Strasbourg | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Marie-Céline FLEURY, MD | |
| Principal Investigator: Marie-Céline FLEURY, MD | |
| Service d'Explorations Fonctionelles Neuro-Musculaires, Hôpital Rangueil, CHU de Toulouse | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Marie-Christine ARNE-BES, MD | |
| Principal Investigator: Marie-Christine ARNE-BES, MD | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Nadia Vandenberghe, MD | Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon |
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01551940 History of Changes |
| Other Study ID Numbers: | 2010.607/11 |
| Study First Received: | March 9, 2012 |
| Last Updated: | March 12, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Sialorrhea Amyotrophic lateral sclerosis Botulinum toxin |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Sialorrhea Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
Salivary Gland Diseases Mouth Diseases Stomatognathic 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