Recurrent Crying Spells in Cerebral Palsy (RCSCPSQ)

Sathbhavana Brain Clinic

Status and phase: Completed; Phase 4

Conditions: Recurrent Crying Spells

Treatments: Drug: Baclofen; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01955655

RCSCPSQ

Details and patient eligibility

About

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

Full description

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

Enrollment: 70 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Baclofen

Active Comparator group

Description:

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.

Treatment:

Drug: Baclofen

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo