A clinical trial to study the effect of propranolol in reducing tremors in patients suffering from spinocerebellar ataxia 12.
Not Applicable
- Conditions
- Health Condition 1: G328- Other specified degenerative disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2022/11/047156
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•All genetically proven SCA 12 patients with tremors.
•Age 18 yrs to 60 years.
•Tremor severity score of at least 2 in at least one upper extremity on at least one of the three manoeuvres on the TETRAS scale.
Exclusion Criteria
1.Patients with conditions that are absolute or relative contraindications to the use of beta blockers-
a. Bronchial asthma, COPD
b. Peripheral vascular disease
c. Diabetes Mellitus
d. Acute Heart failure
e. heart block
f. bradycardia with heart rate less than 60 bpm
blood pressure less than 90 mm Hg systolic and 60 mm Hg diastolic.
2. All other possible causes of tremors
a. Hyperthyroidism
b. Parkinsonism
c.drugs like beta agonists ,theophylline, valproate, lamotrigine
3.Not giving consent
4.Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the change in TETRAS PS scores and composite of TETRAS PS + ADL scores after receiving oral propranolol starting from dose of 40 mg to a maximum dose of 240 mg or the maximum tolerated dose at the end of 4 weeks and 8 weeks of stable dose. <br/ ><br>A clinically meaningful reduction in tremor will be defined as a 30% reduction in TETRAS PS score as well composite TETRAS PS + ADL score from the baseline. <br/ ><br>Timepoint: At the end of 4 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. <br/ ><br>At the end of 8 weeks of stable dose i.e 240 mg or maximum tolerated dose of propranolol. <br/ ><br>
- Secondary Outcome Measures
Name Time Method