Back to resultsRecurrent Crying Spells in Cerebral Palsy (RCSCPSQ)
Primary Purpose
Recurrent Crying Spells
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Baclofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Crying Spells focused on measuring Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
Eligibility Criteria
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
Sites / Locations
- Sathbhavana Brain Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Baclofen
placebo
Arm Description
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.
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01955655
First Posted
September 21, 2013
Last Updated
October 6, 2013
Sponsor
Sathbhavana Brain Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01955655
Brief Title
Recurrent Crying Spells in Cerebral Palsy
Acronym
RCSCPSQ
Official Title
Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sathbhavana Brain Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
Detailed Description
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Crying Spells
Keywords
Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baclofen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Fructose powder.
Primary Outcome Measure Information:
Title
Change from baseline cry duration in seconds over a 10-day period while on placebo.
Description
Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.
Time Frame
11th to 20th day and 51st day to 60th day
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagabhushana Rao Potharaju, BScDCHMDDM
Organizational Affiliation
Sathbhavana Brain Clinic, Secunderabad, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sathbhavana Brain Clinic
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500025
Country
India
12. IPD Sharing Statement
Learn more about this trial
Recurrent Crying Spells in Cerebral Palsy
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