Cerebral PalsyPhase 4ECCCPCDNCT04523935
Excessive Crying in Children With Cerebral Palsy and Communication Deficits
A Phase 4 study testing Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline. in people with Cerebral Palsy and Excessive Crying, run by Sathbhavana Brain Clinic.
Trial summary
Management of excessive crying in children with cerebral palsy and communication deficits [ECCCPCD] was guided by the associated clinical findings and investigations. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Cerebral Palsy, Excessive Crying, Pain
- What is being tested?
- Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2005to 4 Aug 2020
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms.
- Excessive crying due to known causes.
- Progressive encephalopathies.
About this study
Official title: Excessive Crying in Children With Cerebral Palsy and Communication Deficits -a Fixed-sequence, Crossover Clinical Trial
Management of excessive crying in children with cerebral palsy and communication deficits [ECCCPCD] was guided by the associated clinical findings and investigations.
Read the detailed description
Pain treatments are frequently hit or miss, trial \& error, or because of the fear of litigations, not offered at all, particularly in cerebral palsy. Pain is an under-suspected and under-diagnosed cause of ECCCPCD. It was hypothesized that pain/discomfort was responsible for ECCCPCD, and a vicious cycle of pain-spasm-pain aggravated the pain/discomfort. So, the response of ECCCPCD to treatment guided by clinical findings \& investigations was studied.
There was an initial placebo run-in period. This study was a prospective, single-center, interventional, with initial placebo-control, double-blind for initial 110 days, open-label for the next 290 days, fixed-sequence, two treatment, two-period, crossover clinical trial. The placebo run-in period (15 days) was followed by the placebo period (15 days). After a washout period (10 days), drug treatment (360 days) was started depending on the clinical findings and investigations. The drugs used either singly or in various combinations were GABA-B agonists, muscarinic acetylcholine receptor antagonists, benzodiazepines, inhibitors of the vesicular monoamine transporter, antiepileptics, and tricyclic antidepressants. The outcome measure was total, and unexplained mean cry durations in hours per day. The cry duration was measured for one 10-day period while on placebo [days P6-P15], and four 10-day periods while on treatment [T61-70, T241-250, T311-320, and T351-360]. Total and unexplained mean cry durations in hours per day were calculated from 10-day measurements of cry durations. From the 251st day of therapy, the dose was reduced by 5% every week until [ECCCPCD] started to increase. This reduction of the dose was made to confirm the efficacy of drugs and to check if the dosage requirement has reduced after 250 days of treatment. This dose was maintained until the next measurement between T311 and T320. Then the dosages were adjusted as necessary. The caregivers were allowed to volunteer any additional observations of interest. Drug adverse effects were recorded.
Epidemiological data, GMFCS levels, and MAS scores were noted at the time of enrollment. Summary statistics were tabulated and plotted. Paired t-tests and Wilcoxon tests were done to study the statistical significance.
- Conditions
- Cerebral Palsy, Excessive Crying, Pain
- Being tested
- Placebo, Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.
- Keywords
- Allodynia, Neuropathic pain, Run-in period, childhood onset dystonia, drooling, dysphagia, hyperalgesia, muscle spasticity
- Medical subject headings
- Cerebral Palsy, Pain, Hyperalgesia, Neuralgia, Dystonic Disorders, Sialorrhea, Deglutition Disorders, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Fruit sugar, levulose.
Fructose powder identical with the drugs was used
Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.Drug
Also called Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),Amitriptyline(Elavil®)
Drugs were used either singly or in combination guided by clinical findings and investigations.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Sequence 1 | Placebo comparator | The placebo contained fructose powder in packets identical to the medicines. Receives: Other: Placebo |
| Drug-Sequence 2 | Active comparator | GABA-B agonists, muscarinic acetylcholine receptor antagonists, inhibitors of the vesicular monoamine transporter, benzodiazepines, antiepileptics, and tricyclic antidepressants were used. Receives: Drug: Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic data (Age and sex).
Epidemiologic data (age rounded up in years, sex-number of males, females, and transgender, if any).
Measured: 400 days.
The Gross Motor Function Classification System (GMFCS) levels
The gross motor function of children with cerebral palsy was categorized into 5 different levels using the Gross Motor Function Classification System tool. A higher score means a worse condition.
Measured: 400 days
The Modified Ashworth Scale (MAS) scores
The Modified Ashworth Scale (MAS) scores from 0 to 4 were used. A higher score means a worse condition.
Measured: 400 days
Measurement of both Total and Unexplained cry durations
Caregivers measured both Total and Unexplained cry durations with a digital watch or a mobile phone in hours: minutes: seconds over five ten-day periods. MM1 while on placebo days 6-15 [P6-P15], and four measurements MM2 to MM5 while on treatment days 61-70 [T61-70], 241-250 [T241-250], 311-320 [T311-320], and 351-360 [T351-360].
Statistician calculated means of cry duration in hours per day.
Measured: 400 days
Secondary outcomes (1)
Any other changes in the clinical profile observed during the study period and reported by the caregivers.
Any other changes in the clinical profile (frequency changes) observed during the study period were reported by the caregivers. The number and percentages of children with the change were calculated.
Measured: 400 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start7 Dec 2005
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- There was an initial placebo run-in period. This clinical trial was a prospective, single-center, interventional, with initial placebo-control, double-blind for initial 110 days, open-label for the next 290 days, fixed-sequence, two-treatment, two-period, crossover clinical trial. The placebo run-in period (15 days) was followed by the placebo period (15 days). After a washout period (10 days), drug treatment (360 days) was started depending on the clinical findings and investigations.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 131 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, BScMDDCHDM, Principal investigator, Sathbhavana Brain Clinic, Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523935
- Sponsor's protocol ID
- ECCP
- Acronym
- ECCCPCD
- Status last verified
- Oct 2021
- First submitted
- 12 Aug 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: They must acknowledge the sharing.
Publications
Hagglund G, Burman-Rimstedt A, Czuba T, Alriksson-Schmidt AI. Self-versus Proxy-Reported Pain in Children with Cerebral Palsy: A Population-Based Registry Study of 3783 Children. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720911523. doi: 10.1177/2150132720911523.
PubMed 32172660Ostojic K, Paget SP, Morrow AM. Management of pain in children and adolescents with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):315-321. doi: 10.1111/dmcn.14088. Epub 2018 Oct 31.
PubMed 30378122Parkinson KN, Dickinson HO, Arnaud C, Lyons A, Colver A; SPARCLE group. Pain in young people aged 13 to 17 years with cerebral palsy: cross-sectional, multicentre European study. Arch Dis Child. 2013 Jun;98(6):434-40. doi: 10.1136/archdischild-2012-303482. Epub 2013 Apr 20.
PubMed 23606716Fairhurst C, Shortland A, Chandler S, Will E, Scrutton D, Simonoff E, Baird G. Factors associated with pain in adolescents with bilateral cerebral palsy. Dev Med Child Neurol. 2019 Aug;61(8):929-936. doi: 10.1111/dmcn.14113. Epub 2018 Dec 3.
PubMed 30508224Alriksson-Schmidt A, Hagglund G. Pain in children and adolescents with cerebral palsy: a population-based registry study. Acta Paediatr. 2016 Jun;105(6):665-70. doi: 10.1111/apa.13368. Epub 2016 Mar 30.
PubMed 26880375Hauer J, Houtrow AJ; SECTION ON HOSPICE AND PALLIATIVE MEDICINE, COUNCIL ON CHILDREN WITH DISABILITIES. Pain Assessment and Treatment in Children With Significant Impairment of the Central Nervous System. Pediatrics. 2017 Jun;139(6):e20171002. doi: 10.1542/peds.2017-1002.
PubMed 28562301Westbom L, Rimstedt A, Nordmark E. Assessments of pain in children and adolescents with cerebral palsy: a retrospective population-based registry study. Dev Med Child Neurol. 2017 Aug;59(8):858-863. doi: 10.1111/dmcn.13459. Epub 2017 May 16.
PubMed 28509356Penner M, Xie WY, Binepal N, Switzer L, Fehlings D. Characteristics of pain in children and youth with cerebral palsy. Pediatrics. 2013 Aug;132(2):e407-13. doi: 10.1542/peds.2013-0224. Epub 2013 Jul 15.
PubMed 23858420Baxter P. Comorbidities of cerebral palsy need more emphasis--especially pain. Dev Med Child Neurol. 2013 May;55(5):396. doi: 10.1111/dmcn.12137. No abstract available.
PubMed 23574476Barney CC, Krach LE, Rivard PF, Belew JL, Symons FJ. Motor function predicts parent-reported musculoskeletal pain in children with cerebral palsy. Pain Res Manag. 2013 Nov-Dec;18(6):323-7. doi: 10.1155/2013/813867.
PubMed 24308022Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.
PubMed 22014321Ostojic K, Paget S, Kyriagis M, Morrow A. Acute and Chronic Pain in Children and Adolescents With Cerebral Palsy: Prevalence, Interference, and Management. Arch Phys Med Rehabil. 2020 Feb;101(2):213-219. doi: 10.1016/j.apmr.2019.08.475. Epub 2019 Sep 12.
PubMed 31521713Tedroff K, Gyllensvard M, Lowing K. Prevalence, identification, and interference of pain in young children with cerebral palsy: a population-based study. Disabil Rehabil. 2021 May;43(9):1292-1298. doi: 10.1080/09638288.2019.1665719. Epub 2019 Sep 17.
PubMed 31526138Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.
PubMed 21148657Blackman JA, Svensson CI, Marchand S. Pathophysiology of chronic pain in cerebral palsy: implications for pharmacological treatment and research. Dev Med Child Neurol. 2018 Sep;60(9):861-865. doi: 10.1111/dmcn.13930. Epub 2018 Jun 7.
PubMed 29882358
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excessive Crying in Children With Cerebral Palsy and Communication Deficits -a Fixed-sequence, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04523935
- Acronym / sponsor ID
- ECCCPCD / ECCP
- Conditions
- Cerebral Palsy, Excessive Crying, Pain
- Keywords
- Allodynia, Neuropathic pain, Run-in period, childhood onset dystonia, drooling, dysphagia, hyperalgesia, muscle spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Sathbhavana Brain ClinicUniversity, hospital or other
- Study start
- 7 Dec 2005 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 24 Aug 2020 (actual)
- 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.
Management of excessive crying in children with cerebral palsy and communication deficits [ECCCPCD] was guided by the associated clinical findings and investigations.
Detailed description
Pain treatments are frequently hit or miss, trial \& error, or because of the fear of litigations, not offered at all, particularly in cerebral palsy. Pain is an under-suspected and under-diagnosed cause of ECCCPCD. It was hypothesized that pain/discomfort was responsible for ECCCPCD, and a vicious cycle of pain-spasm-pain aggravated the pain/discomfort. So, the response of ECCCPCD to treatment guided by clinical findings \& investigations was studied.
There was an initial placebo run-in period. This study was a prospective, single-center, interventional, with initial placebo-control, double-blind for initial 110 days, open-label for the next 290 days, fixed-sequence, two treatment, two-period, crossover clinical trial. The placebo run-in period (15 days) was followed by the placebo period (15 days). After a washout period (10 days), drug treatment (360 days) was started depending on the clinical findings and investigations. The drugs used either singly or in various combinations were GABA-B agonists, muscarinic acetylcholine receptor antagonists, benzodiazepines, inhibitors of the vesicular monoamine transporter, antiepileptics, and tricyclic antidepressants. The outcome measure was total, and unexplained mean cry durations in hours per day. The cry duration was measured for one 10-day period while on placebo [days P6-P15], and four 10-day periods while on treatment [T61-70, T241-250, T311-320, and T351-360]. Total and unexplained mean cry durations in hours per day were calculated from 10-day measurements of cry durations. From the 251st day of therapy, the dose was reduced by 5% every week until [ECCCPCD] started to increase. This reduction of the dose was made to confirm the efficacy of drugs and to check if the dosage requirement has reduced after 250 days of treatment. This dose was maintained until the next measurement between T311 and T320. Then the dosages were adjusted as necessary. The caregivers were allowed to volunteer any additional observations of interest. Drug adverse effects were recorded.
Epidemiological data, GMFCS levels, and MAS scores were noted at the time of enrollment. Summary statistics were tabulated and plotted. Paired t-tests and Wilcoxon tests were done to study the statistical significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- There was an initial placebo run-in period. This clinical trial was a prospective, single-center, interventional, with initial placebo-control, double-blind for initial 110 days, open-label for the next 290 days, fixed-sequence, two-treatment, two-period, crossover clinical trial. The placebo run-in period (15 days) was followed by the placebo period (15 days). After a washout period (10 days), drug treatment (360 days) was started depending on the clinical findings and investigations.
| Arm | Type | Receives |
|---|---|---|
| Placebo-Sequence 1 | Placebo comparator | Other: PlaceboThe placebo contained fructose powder in packets identical to the medicines. |
| Drug-Sequence 2 | Active comparator | Drug: Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.GABA-B agonists, muscarinic acetylcholine receptor antagonists, inhibitors of the vesicular monoamine transporter, benzodiazepines, antiepileptics, and tricyclic antidepressants were used. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms.
- Excessive crying due to known causes.
- Progressive encephalopathies.
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 |
|---|---|---|
| PlaceboAlso: Fruit sugar, levulose.Fructose powder identical with the drugs was used | Other | Placebo-Sequence 1 |
| Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.Also: Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),Amitriptyline(Elavil®)Drugs were used either singly or in combination guided by clinical findings and investigations. | Drug | Drug-Sequence 2 |
Primary outcome
Epidemiologic data (Age and sex).
Time frame: 400 days.
Epidemiologic data (age rounded up in years, sex-number of males, females, and transgender, if any).
The Gross Motor Function Classification System (GMFCS) levels
Time frame: 400 days
The gross motor function of children with cerebral palsy was categorized into 5 different levels using the Gross Motor Function Classification System tool. A higher score means a worse condition.
The Modified Ashworth Scale (MAS) scores
Time frame: 400 days
The Modified Ashworth Scale (MAS) scores from 0 to 4 were used. A higher score means a worse condition.
Measurement of both Total and Unexplained cry durations
Time frame: 400 days
Caregivers measured both Total and Unexplained cry durations with a digital watch or a mobile phone in hours: minutes: seconds over five ten-day periods. MM1 while on placebo days 6-15 [P6-P15], and four measurements MM2 to MM5 while on treatment days 61-70 [T61-70], 241-250 [T241-250], 311-320 [T311-320], and 351-360 [T351-360]. Statistician calculated means of cry duration in hours per day.
1 secondary outcome
Any other changes in the clinical profile observed during the study period and reported by the caregivers.
Time frame: 400 days
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 28 Oct 2021.
- Background: PubMed 32172660Hagglund G, Burman-Rimstedt A, Czuba T, Alriksson-Schmidt AI. Self-versus Proxy-Reported Pain in Children with Cerebral Palsy: A Population-Based Registry Study of 3783 Children. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720911523. doi: 10.1177/2150132720911523.
- Background: PubMed 30378122Ostojic K, Paget SP, Morrow AM. Management of pain in children and adolescents with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):315-321. doi: 10.1111/dmcn.14088. Epub 2018 Oct 31.
- Background: PubMed 23606716Parkinson KN, Dickinson HO, Arnaud C, Lyons A, Colver A; SPARCLE group. Pain in young people aged 13 to 17 years with cerebral palsy: cross-sectional, multicentre European study. Arch Dis Child. 2013 Jun;98(6):434-40. doi: 10.1136/archdischild-2012-303482. Epub 2013 Apr 20.
- Background: PubMed 30508224Fairhurst C, Shortland A, Chandler S, Will E, Scrutton D, Simonoff E, Baird G. Factors associated with pain in adolescents with bilateral cerebral palsy. Dev Med Child Neurol. 2019 Aug;61(8):929-936. doi: 10.1111/dmcn.14113. Epub 2018 Dec 3.
- Background: PubMed 26880375Alriksson-Schmidt A, Hagglund G. Pain in children and adolescents with cerebral palsy: a population-based registry study. Acta Paediatr. 2016 Jun;105(6):665-70. doi: 10.1111/apa.13368. Epub 2016 Mar 30.
- Background: PubMed 28562301Hauer J, Houtrow AJ; SECTION ON HOSPICE AND PALLIATIVE MEDICINE, COUNCIL ON CHILDREN WITH DISABILITIES. Pain Assessment and Treatment in Children With Significant Impairment of the Central Nervous System. Pediatrics. 2017 Jun;139(6):e20171002. doi: 10.1542/peds.2017-1002.
- Background: PubMed 28509356Westbom L, Rimstedt A, Nordmark E. Assessments of pain in children and adolescents with cerebral palsy: a retrospective population-based registry study. Dev Med Child Neurol. 2017 Aug;59(8):858-863. doi: 10.1111/dmcn.13459. Epub 2017 May 16.
- Background: PubMed 23858420Penner M, Xie WY, Binepal N, Switzer L, Fehlings D. Characteristics of pain in children and youth with cerebral palsy. Pediatrics. 2013 Aug;132(2):e407-13. doi: 10.1542/peds.2013-0224. Epub 2013 Jul 15.
- Background: PubMed 23574476Baxter P. Comorbidities of cerebral palsy need more emphasis--especially pain. Dev Med Child Neurol. 2013 May;55(5):396. doi: 10.1111/dmcn.12137. No abstract available.
- Background: PubMed 24308022Barney CC, Krach LE, Rivard PF, Belew JL, Symons FJ. Motor function predicts parent-reported musculoskeletal pain in children with cerebral palsy. Pain Res Manag. 2013 Nov-Dec;18(6):323-7. doi: 10.1155/2013/813867.
- Background: PubMed 22014321Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.
- Background: PubMed 31521713Ostojic K, Paget S, Kyriagis M, Morrow A. Acute and Chronic Pain in Children and Adolescents With Cerebral Palsy: Prevalence, Interference, and Management. Arch Phys Med Rehabil. 2020 Feb;101(2):213-219. doi: 10.1016/j.apmr.2019.08.475. Epub 2019 Sep 12.
- Individual participant dataSharing planned: Yes. They must acknowledge the sharing.
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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, BScMDDCHDM principal investigator
Sathbhavana Brain Clinic, Hyderabad, India
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline. in people with Cerebral Palsy and Excessive Crying, run by Sathbhavana Brain Clinic.
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 0 inclusion and 3 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Epidemiologic data (Age and sex). (time frame: 400 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04523935, which also lists 25 linked publications.
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 28 Oct 2021.