Adductor type spasmodic dysphonia Abductor type spasmodic dysphonia
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Botulinum toxin type A
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAMUSCULAR
Dose per admin
Sponsors
Kochi medical school hospital
Masamitsu Hyodo Department of Otolaryngology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Targeting those who meet all of the following selection criteria to obtaining informed consent at the time. (1) Abductor type spasmodic dysphonia patients and the adductor type has a discontinuity, such as voice and effort dysphonia, an abnormal number of Mora has a dysphonia of 12/25 or more. (2) Age of consent at the time of obtaining a patient of 12 years of age or older. (3) Patients that can be document of informed consent from the person. However, if under 20 years of age, the age of consent at the time of obtaining the patient capable of obtaining informed consent document of the (parent or legal guardian) and legal representative's Ascent acquisition by the document of the person. (4) Male patient capable of contraception of the study period. (5)Also acceptable fertile female patient if it meets the following conditions: 1) Pregnancy test immediately before the administration and screening-life patients who are negative. 2) Patients that can be agreed to contraception reliably during the study.
Exclusion criteria
Exclusion criteria: Those who answer to any one of the following exclusion criteria to obtaining informed consent at the time are excluded from. (1) Patients with a disorder of the neuromuscular junction of systemic. (such as Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis) (2) Patients receiving antibiotics with a neuromuscular junction blocking action, such as polypeptide antibiotic(ex: polymyxin B sulfate) and aminoglycoside antibiotics, (ex: Gentamicin sulfate, and fradiomycin sulfate) tetracycline antibiotics, lincomycin antibiotics. Excepting the external preparation. (3) Patients receiving drugs with a muscle relaxant effect and a muscle relaxant. (4) Patients with respiratory failure chronic. (5) Patients with atrophy or muscle weakness severe. (6) Patients with angle-closure glaucoma or the predisposition (such as narrow angle). (7) Patients who wish to become pregnant during the study and patients are likely to pregnant women, nursing mothers, pregnant. (8) Patients with allergy or hypersensitivity (botulinum toxin, and anesthetics) for agents used in clinical trials. (9) Patients having a vocal cord paralysis or dysphagia. (10) Patients who had undergone surgery therapy for spasmodic dysphonia in the past. (11) Patients who had received a voice therapy within 8 weeks before obtaining informed consent. (12) Patients who had received a dose of the anticonvulsant or botulinum toxin for 24 weeks before obtaining informed consent. In addition, patients scheduled to undergo administration for cosmetic purposes or treatment of other diseases during the study. (13) Patients to determine changes in the symptoms and greater overall investigator is (sharing) patient or physician, is provided with a observation period of 2-3 weeks after obtaining consent, mora number varies by more than 50% in the meantime. (14) Patient hospitalization or surgery is scheduled during the study. (15) Patients participating in clinical trials of another 12 weeks before obtaining informed consent and the patients who are attending the trial of the other after incorporation into the trial. (16) Patients with heart, liver and kidney dysfunction serious. (17) Patients with intellectual impairment or mental disorder affecting the clinical trial performance or consent capacity. (18) Patients with a history of drug abuse or alcohol dependence. (19) children with facility care. (20)Patients with investigator (sharing) doctor is judged to be not eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in the number of moras | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of change in the number of mora Hearing psychological evaluation (GRBAS scale) Awareness assessment (Voice Handicap Index: VHI) Awareness rating (Visual Analogue Scale: VAS) | — |
Countries
Japan
Contacts
Public ContactKento Asano
Kochi Medical School Hospital
Outcome results
None listed