Last updated: September 16, 2021
Sponsor: Rajavithi Hospital
Overall Status: Completed
Phase
3
Condition
Dystonia
Dyskinesias
Dystonias
Treatment
N/AClinical Study ID
NCT04582929
A-02-2020
Ages 20-100 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
•The subject has to grant permission to enter into the study by signing and dating theinformed consent form before completing any study-related procedure such as any assessmentor 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 investigatorto avoid pregnancy during the study and to use condom or other contraceptive measureif necessary. The subject was required to have a negative urine pregnancy test beforebeing eligible for the study. (At each of the subsequent visit, a urine pregnancy testwas performed).
- Subject judged to be reliable for compliance for taking medication and capable ofrecording the effects of the medication and motivated in receiving benefits from thetreatment.
- Subject should undergo a normal physical and neurological examination TWSTRS, CDIP-58,SF36, and CES-D • during the whole study period
Exclusion
Exclusion Criteria:
- The subject was pregnant or lactating.
- The subject was a female at risk of pregnancy during the study and not taking adequateprecautions against pregnancy.
- The subject had a known hypersensitivity to any of the test materials or relatedcompounds.
- 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. myastheniagravis, Lambert - Elton Syndrome)
- Subject with significant medical / neurological / psychiatric disorders such as blooddyscrasia, thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronaryartery heart diseases, dementia, psychosis, or other conditions which could influencethe clinical trial.
- Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinumtoxin type A) allergy.
- Unable to cooperate fill-up TWSTRS, CDIP-58, SF36, and CES-D • Patient who planned toschedule elective surgery during the study.
- The used of aminoglycoside antibiotics and curare were not allowed during the study.
Study Design
Total Participants: 50
Study Start date:
January 03, 2019
Estimated Completion Date:
May 30, 2021
Study Description
Connect with a study center
Rajavithi Hospital
Bangkok, 10400
ThailandSite Not Available
Lampang Hospital
Lampang, 52000
ThailandSite Not Available
Suratthani Hospital
Surat Thani, 84000
ThailandSite Not Available
Sappasitthiprasong Hospital
Ubon Ratchathani, 34000
ThailandSite Not Available
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