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
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Crying Spells||Drug: Baclofen Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
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.
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
|Sathbhavana Brain Clinic|
|Secunderabad, Andhra Pradesh, India, 500025|
|Principal Investigator:||Nagabhushana Rao Potharaju, BScDCHMDDM||Sathbhavana Brain Clinic, Secunderabad, India|