Excessive Crying in Children With Cerebral Palsy and Communication Deficits
CompletedPhase 4NCT04523935
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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
- Cerebral Palsy
- Excessive Crying
- Pain
- 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