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Recurrent Crying Spells in Cerebral Palsy (RCSCPSQ)

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ClinicalTrials.gov Identifier: NCT01955655
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Dr.Nagabhushana Rao Potharaju, Sathbhavana Brain Clinic

Study Description
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Brief Summary:
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

Condition or disease Intervention/treatment Phase
Recurrent Crying Spells Drug: Baclofen Other: Placebo Phase 4

Detailed Description:
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
Study Start Date : December 2005
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arms and Interventions
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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 Name: Fructose powder.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955655


Locations
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India
Sathbhavana Brain Clinic
Secunderabad, Andhra Pradesh, India, 500025
Sponsors and Collaborators
Sathbhavana Brain Clinic
Investigators
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Principal Investigator: Nagabhushana Rao Potharaju, BScDCHMDDM Sathbhavana Brain Clinic, Secunderabad, India
More Information
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Responsible Party: Dr.Nagabhushana Rao Potharaju, Principal Investigator, Sathbhavana Brain Clinic
ClinicalTrials.gov Identifier: NCT01955655    
Other Study ID Numbers: RCSCPSQ
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013
Keywords provided by Dr.Nagabhushana Rao Potharaju, Sathbhavana Brain Clinic:
Baclofen
cerebral palsy
colic
crying infant
 recurrent crying spells
spasticity
therapy
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
 Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action