Recurrent Crying Spells in Cerebral Palsy

Recurrent Crying Spells Clinical Trial

— RCSCPSQ  

Official title:

Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955655
• Other study ID #: RCSCPSQ
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2013
• Last updated: October 6, 2013
• Start date: December 2005
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Sathbhavana Brain Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

Description:

This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.

• Age range 0-12 years.

Exclusion Criteria:

• Crying due to known causes (like hunger, sleep, food intolerance etc.),

• Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics),

• Fever of =100.4ºF (38ºC),

• The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness).

• Colic

• Worst ever crying occurring for the first time

• Respiratory, renal and hepatic diseases,

• Progressive encephalopathies,

• Received Baclofen in the previous 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Recurrent Crying Spells

Intervention

Drug:
• Baclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.

Other:
• Placebo

Locations

Country	Name	City	State
India	Sathbhavana Brain Clinic	Secunderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Sathbhavana Brain Clinic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline cry duration in seconds over a 10-day period while on placebo.	Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.	11th to 20th day and 51st day to 60th day	No