Recurrent Crying Spells in Cerebral Palsy (RCSCPSQ)

October 6, 2013 updated by: Dr.Nagabhushana Rao Potharaju, Sathbhavana Brain Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500025
        • Sathbhavana Brain Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Baclofen
The starting dose was 0.75 mg/kg in four divided doses daily and was cautiously increased at three-day intervals until crying subsided or symptoms of over dosage or side effects appeared. The usual maximum dose was two mg/kg in four divided doses daily.
Drug: Baclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
Placebo Comparator: placebo
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
Other: Placebo
Other Names:
  • Fructose powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline cry duration in seconds over a 10-day period while on placebo.
Time Frame: 11th to 20th day and 51st day to 60th day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sathbhavana Brain Clinic

Investigators

  • Principal Investigator: Nagabhushana Rao Potharaju, BScDCHMDDM, Sathbhavana Brain Clinic, Secunderabad, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 29, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 6, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCSCPSQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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