Trial | NCT01955655  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    baclofen ...

  • Study Participants

    70
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
Study Started
Dec 31
2005
Primary Completion
Aug 31
2013
Study Completion
Aug 31
2013
Last Update
Oct 08
2013
Estimate

Drug Baclofen

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

Other Placebo

  • Other names: Fructose powder.

Baclofen Active Comparator

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 Placebo Comparator

Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.

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
No Results Posted