Recurrent Crying SpellsPhase 4RCSCPSQNCT01955655
Recurrent Crying Spells in Cerebral Palsy
A Phase 4 study testing Baclofen in people with Recurrent Crying Spells, run by Sathbhavana Brain Clinic at 1 site in India.
Trial summary
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Recurrent Crying Spells
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2005to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
- Age range 0-12 years.
Who cannot join
- 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
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- Respiratory, renal and hepatic diseases,
- Progressive encephalopathies,
- Received Baclofen in the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
Read the detailed description
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
- Conditions
- Recurrent Crying Spells
- Being tested
- Baclofen, Placebo
- Keywords
- Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
- Medical subject headings
- Cerebral Palsy, Colic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
PlaceboOther
Also called Fructose powder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Baclofen |
| placebo | Placebo comparator | Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11th to 20th day and 51st day to 60th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startDec 2005
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Crying SpellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sathbhavana Brain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Nagabhushana Rao Potharaju, Sathbhavana Brain Clinic
- Investigators
- Nagabhushana Rao Potharaju, BScDCHMDDM, Principal investigator, Sathbhavana Brain Clinic, Secunderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955655
- Sponsor's protocol ID
- RCSCPSQ
- Acronym
- RCSCPSQ
- Status last verified
- Oct 2013
- First submitted
- 21 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
- ClinicalTrials.gov ID
- NCT01955655
- Acronym / sponsor ID
- RCSCPSQ / RCSCPSQ
- Conditions
- Recurrent Crying Spells
- Keywords
- Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sathbhavana Brain ClinicUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
Detailed description
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Active comparator | Drug: BaclofenThe 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 | Other: PlaceboPlacebo contained fructose powder in equal quantity in packets mimicking those of Baclofen. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
- Age range 0-12 years.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenSince the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used. | Drug | Baclofen |
| PlaceboAlso: Fructose powder. | Other | placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagabhushana Rao Potharaju, BScDCHMDDM principal investigator
Sathbhavana Brain Clinic, Secunderabad, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen in people with Recurrent Crying Spells, run by Sathbhavana Brain Clinic at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.