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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagabhushana Rao Potharaju, BScDCHMDDM | Sathbhavana Brain Clinic, Secunderabad, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sathbhavana Brain Clinic | Secunderabad | Andhra Pradesh | 500025 | India |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D003085 | Colic |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Other |
|
|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |