Recurrent Crying Spells in Cerebral Palsy (RCSCPSQ)
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ClinicalTrials.gov Identifier: NCT01955655 |
Recruitment Status :
Completed
First Posted : October 7, 2013
Last Update Posted : October 8, 2013
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Condition or disease | Intervention/treatment | Phase |
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Recurrent Crying Spells | Drug: Baclofen Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Baclofen
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.
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Drug: Baclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used. |
Placebo Comparator: placebo
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
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Other: Placebo
Other Name: Fructose powder. |
- Change from baseline cry duration in seconds over a 10-day period while on placebo. [ Time Frame: 11th to 20th day and 51st day to 60th day ]Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.

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Ages Eligible for Study: | up to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955655
India | |
Sathbhavana Brain Clinic | |
Secunderabad, Andhra Pradesh, India, 500025 |
Principal Investigator: | Nagabhushana Rao Potharaju, BScDCHMDDM | Sathbhavana Brain Clinic, Secunderabad, India |
Responsible Party: | Dr.Nagabhushana Rao Potharaju, Principal Investigator, Sathbhavana Brain Clinic |
ClinicalTrials.gov Identifier: | NCT01955655 |
Other Study ID Numbers: |
RCSCPSQ |
First Posted: | October 7, 2013 Key Record Dates |
Last Update Posted: | October 8, 2013 |
Last Verified: | October 2013 |
Baclofen cerebral palsy colic crying infant |
recurrent crying spells spasticity therapy |
Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Baclofen Muscle Relaxants, Central Physiological Effects of Drugs |
Neuromuscular Agents Peripheral Nervous System Agents GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |