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Excessive Crying in Children With Cerebral Palsy and Communication Deficits

CompletedPhase 4NCT04523935
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Management of excessive crying in children with cerebral palsy and communication deficits \[ECCCPCD\] was guided by the associated clinical findings and investigations.

Study details

Official title
Excessive Crying in Children With Cerebral Palsy and Communication Deficits -a Fixed-sequence, Crossover Clinical Trial
Conditions
Interventions
  • Other: Placebo
  • Drug: Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.
Sponsor
Sathbhavana Brain Clinic
Start date
2005-12-07
Primary completion
2020-08-04
Sex
All
Age range
to 15 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
1. A child with cerebral palsy under the age of 15 years and could not communicate the reason for excessive crying because of young age or global developmental delay/profound intellectual retardation. 2. Excessive crying of \>7.5 hours daily for 30 consecutive days unresponsive to treatment by the pediatrician, orthopedic surgeon, gastroenterologist, and physiotherapist. 3. Minimum cry intensity for recording: If the intensity of crying was so high that the caregiver could not hear radio, TV, or another person talking to her \[sitting near her\], the cry duration was recorded. 4. History, clinical, and neuroimaging findings (structural MRI) were suggestive of chronic static encephalopathy. 5. Motor impairment could be explained by an insult that occurred in the developing fetal or infant brain. Exclusion Criteria: 1. Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms. 2. Excessive crying due to known causes. 3. Progressive encephalopathies.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04523935