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Completed

NCT Number: NCT01955655

Recurrent Crying Spells in Cerebral Palsy

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

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Key information

Conditions

Recurrent Crying Spells Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sathbhavana Brain Clinic

Secunderabad, Andhra Pradesh, 500025, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

Drug

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

Placebo

Other

Other names: Fructose powder.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sathbhavana Brain Clinic

Other

Registry information

Official study title

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

Acronym: RCSCPSQ

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Oct 7, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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