Onabotulinum toxin A (Botox) in the treatment of central nervous system dysfunction related swallowing difficulty

Phase 2

• Conditions: Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere

• Registration Number: CTRI/2021/01/030809
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients attending neurology OPD with swallowing dysfunction as described above

2. At least 14 years of age of all sexes

3. mRS (modified Rankin scale) of <=3 at time of study enrolment

4. In case of post stroke dysphagia, at least 6 months have passed following stroke

5. Willing to undergo swallowing assessment clinically and with video fluoroscopy/barium swallow, flexible upper GI endoscopy and esophageal manometry before and after the injection

6. Above investigations show impaired cricopharyngeal relaxation, adequate pharyngeal strength and antero-cephalad laryngeal movement

7. Ready to provide consent for botulinum neurotoxin injection.

8. Willing to adhere to protocol and comply with follow up visits

9. No major neurologic or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores

Exclusion Criteria

1. Diagnosed cases of neuromuscular disorders of the peripheral nervous system and ALS

2. mRS at time of enrolment >3

3. Patients with expected life expectancy less than 1 year due to primary disease or co-morbidity based on clinical prediction scores

4. Known allergy to botulinum neurotoxin or its preservatives/excipients

5. Received botulinum toxin for any indication in the last 12 weeks

6. Those with known antibodies against Botulinum neurotoxin A

7. Those who underwent myotomy of the cricopharyngeus muscle

8. Those who had undergone procedures like denervation of the cervical musculature

9. Dysphagia of other causes not fulfilling inclusion criteria

10. Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating

11. Not willing to provide consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified