Cervical Dystonia Clinical Trial
— DNCDOfficial title:
A 48-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of 250 Unit of Dysport Versus 50 Unit of Neuronox Injection For Cervical Dystonia in Thai Patients
Verified date | March 2021 |
Source | Rajavithi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 48-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of, 250 unit of Abobotulinum Toxin Type A (Dysport) and 50 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of Abobotulinum Toxin Type A (Dysport) injection versus Neubotulinum Toxin Type A (Neuronox)Injection.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - The subjects need to satisfy the following criteria before being allowed to participate in the study: - The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject. - Able to give written inform consent and retained one copy of the consent form • Male or female subject, aged between 18 - 100 years old. - Subject diagnosed to be cervical dystonia. - Female subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed). - Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment. Subject should undergo a normal physical and neurological examination TWSTRS, CDIP-58, SF36, and CES-D • during the whole study period Exclusion Criteria: - The subject WERE NOT ALLOWED TO enter/continue into the study, if :. - The subject was pregnant or lactating. - The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy. - The subject had a known hypersensitivity to any of the test materials or related compounds. - The subject was unable or unwilling to comply fully with the protocol. - The subject received any unlicensed drug within the previous 6 months. - Treatment with investigational drug (s) within 6 months before the screening visit. • The subject had previously entered in this study. - Subject with past history of botulism, other neuromuscular disorder (e.g. myasthenia gravis, Lambert - Elton Syndrome) - Subject with significant medical / neurological / psychiatric disorders such as blood dyscrasia, thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, or other conditions which could influence the clinical trial. - Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy. - Unable to cooperate fill-up TWSTRS, CDIP-58, SF36, and CES-D • Patient who planned to schedule elective surgery during the study. - The used of aminoglycoside antibiotics and curare were not allowed during the study. |
Country | Name | City | State |
---|---|---|---|
Thailand | Assistant Professor Subsai Kongsaengdao | Bangkok | |
Thailand | Lampang Hospital | Lampang | |
Thailand | Surat Thani hospital | Surat Thani | |
Thailand | Sappasithiprasong Hospital | Ubon Ratchathani |
Lead Sponsor | Collaborator |
---|---|
Rajavithi Hospital |
Thailand,
Kongsaengdao S, Maneeton B, Maneeton N. Quality of life in cervical dystonia after treatment with botulinum toxin A: a 24-week prospective study. Neuropsychiatr Dis Treat. 2017 Jan 10;13:127-132. doi: 10.2147/NDT.S116325. eCollection 2017. — View Citation
Kongsaengdao S, Maneeton N, Maneeton B. Long-term quality of life in cervical dystonia after treatment with abobotulinum toxin A: a 2-year prospective study. Neuropsychiatr Dis Treat. 2018 Apr 26;14:1119-1124. doi: 10.2147/NDT.S152252. eCollection 2018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS) | TWSTRS ranged( 0-85 by summation of all 3 sub- scales ) higher represent a worse outcome TWSTRS Sub- scale includes
TWSTRS-Total severity scale ( maximum 35 points) TWSTS-Disability scale (maximum 30 points) TWSTS-Pain scale (maximum 20 points) |
24 week | |
Primary | Cervical Dystonia Impact Profile 58 ( CDIP-58) | ) Cervical Dystonia Impact Profile-58 items composed of 8 sub-scale Total score by summation of 8 subscale higher represent a worse outcome Analysis both total score (range 58-290 points) And sub-scale analysis composed of Head and neck symptoms ( 6 items ; 6-30 points) Pain and discomfort ( 5 items ; 5-25 points) Upper limb activity ( 9 items ; 9-45 points) Walking ( 9 items ; 9-45 points) Sleep ( 4 items ; 4-20 points) Annoyance ( 8 items ; 8-40 points) Mood (7 items ; 7-35 points) Psychosocial functioning ( 10 items ; 10-50 points) | 24 week | |
Secondary | Comparesion the quality of life 36 item ( SF 36) | Comparesion the quality of life (SF 36) pre- and post- 12 and 24 week ttreatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) this score has special formula calculation | 24 week | |
Secondary | Depression scale measured by Center of Epidemiologic Study of Depression 20 item ( CES-D 20) | Comparesion of CES-D pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) Score ranged from 20-80 points higher represent a worse outcome | 24 week | |
Secondary | Depression scale measured by Patient Health Questionnaire Depression Scale (PHQ-9) | Comparesion of PHQ-9 pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) There is the special scale calculation for diagnosis Major depressive disorder, Other depressive disorder and others,higher points /score represent a worse outcome ranged 0-27 points plus 3 points Total summation of 5-9 points indicate Minimal symptoms, 10-14 Minor depression ++ or Dysthymia* or Major depression, mild , 15-19 points Major depression, moderately severe
= 20 Major depression, severe |
24 week | |
Secondary | Clinical Global Impression of Changed ( CGIC) | Comparesion of CGIC pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) | 24 week the scale compose of -3 to 3 higher represent a good outcome |
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