Recurrent Crying Spells in Cerebral Palsy

NCT01955655 | Completed Phase 4 DMC

• 1 other identifier: RCSCPSQ
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Crying Spells

Keywords

Baclofen; cerebral palsy; colic; crying infant; recurrent crying spells; spasticity; therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline cry duration in seconds over a 10-day period while on placebo.

  Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.

  11th to 20th day and 51st day to 60th day

Study Arms (2)

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.

Drug: Baclofen

placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Baclofen DRUG

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

Baclofen

Placebo OTHER

Also known as: Fructose powder.

placebo

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
• Age range 0-12 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sathbhavana Brain Clinic: lead

Study Sites (1)

Sathbhavana Brain Clinic

Secunderabad, Andhra Pradesh, 500025, India

Location

MeSH Terms

Conditions

Cerebral Palsy; Colic; Muscle Spasticity

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nagabhushana Rao Potharaju, BScDCHMDDM

  Sathbhavana Brain Clinic, Secunderabad, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: October 7, 2013
• Study Start: December 1, 2005
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

IN (1)