Study of baclofen in subjects with spasticity
- Conditions
- Health Condition 1: M628- Other specified disorders of muscleHealth Condition 2: null- Subjects with spasticity
- Registration Number
- CTRI/2018/04/013139
- Lead Sponsor
- Sun Pharmaceuticals Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Availability of subject for the entire study period and willingness to adhere to protocol
requirements
- Subjects with history of spasticity for 1 year or more
- Spastic subjects receiving stable daily doses of Baclofen 30mg for at least 1-month prior to
start of study.
- Subjects at least 18-years of age or older, subjects having weight at least 50Kg and the
subjectâ??s body mass index (BMI) must be within 18.5 to 25.0 (Kg/m2) (inclusive).
- Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or
any related compounds etc.
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,
immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease that interferes
with study procedures.
- Subject having history of seizure.
- Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
past one year
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method