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Antiepileptic

Vigabatrin for Tuberous Sclerosis

Phase 2

Waitlist Available

Led By Martina Bebin, MD, MPA

Research Sponsored by Martina Bebin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months, 24 months and 36 months

Awards & highlights

Study Summary

This trial will study whether an experimental drug can prevent seizures in infants with Tuberous Sclerosis Complex.

Eligible Conditions

Tuberous Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months, 24 months and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months, 24 months and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Assessment Scores and Developmental Impact

Secondary outcome measures

EEG Biomarker for Developing Epilepsy

Evaluate Autism Diagnostic Observation Schedule 2nd Edition (ADOS2) Scores and Impact of Early Versus Late Treatment

Evaluate Vineland II Scores and Impact of Early Versus Late Treatment

+4 more

Side effects data

From 2012 Phase 2 & 3 trial • 207 Patients • NCT01281202

21%

Headache

16%

Fatigue

11%

Photopsia

11%

Pain in extremity

Nasopharyngitis

Blood pressure increased

Back pain

Nausea

Pruritus

Insomnia

Hypertension

Immune system disorders

Increased appetite

Contusion

Chest Pain

Loss of conciousness

Eczema

Psychiatric symptom

Dysmenorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

CPP-109 Vigabatrin Tablets

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: VigabatrinExperimental Treatment1 Intervention

Vigabatrin open label is given for administration, the entire content of one sachet (500 mg active drug) is dissolved in 10 ml water for oral administration that is dosed according to body weight 50-150 mg/kg/day divided BID. Dosing will follow established recommended guidelines (50 mg/kg/day and increased as needed by 50 mg/kg/day every 3 days up to a maximum dose of 150 mg/kg/day, divided BID).

Group II: Control GroupActive Control1 Intervention

Enrolled subjects who never develop EEG abnormalities or clinical seizures

Group III: Vigabatrin or PlaceboPlacebo Group2 Interventions

Vigabatrin or Placebo is given for administration, the entire content of one sachet (500 mg active drug) is dissolved in 10 ml water for oral administration that is dosed according to body weight 50-150 mg/kg/day divided BID. Dosing will follow established recommended guidelines (50 mg/kg/day and increased as needed by 50 mg/kg/day every 3 days up to a maximum dose of 150 mg/kg/day, divided BID).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vigabatrin

2008

Completed Phase 3

~420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Martina BebinLead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,277 Total Patients Enrolled

2 Trials studying Tuberous Sclerosis

361 Patients Enrolled for Tuberous Sclerosis

Martina Bebin, MD, MPAPrincipal InvestigatorUniversity of Alabama at Birmingham

1 Previous Clinical Trials

64 Total Patients Enrolled

1 Trials studying Tuberous Sclerosis

64 Patients Enrolled for Tuberous Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with this treatment plan?

"The safety rating for this experimental treatment is assessed as a 2 due to limited clinical evidence of its efficacy, though prior data does suggest a certain level of security."

Answered by AI

To what extent has recruitment for this medical study been successful?

"This medical trial is not currently open for enrollment. It was initially posted on December 1st, 2016 and the information has been revised most recently on May 4th 2022. If you are looking at other options, 725 clinical trials related to aura and 7 studies concerning this particular treatment are actively seeking patients."

Answered by AI

Is the study open to geriatric individuals?

"To participate in this study, patients must not be older than 6 months of age. There are currently 142 trials for those under the age of 18 and 501 for seniors aged 65 and above."

Answered by AI

To what extent have prior experiments been conducted with this medical treatment?

"In 2016, the University of Alabama at Birmingham kicked off this therapeutic intervention. Since then, 18331 clinical trials have been successfully completed and currently 7 additional studies are actively recruiting patients; Palo Alto in California is a major hub for these research activities."

Answered by AI

Does this research offer opportunities for me to participate?

"A prerequisite for acceptance to this research trial is the presence of aura and an age range between 1 day old up to 6 months. The total number of participants needed is 84."

Answered by AI

Is this clinical experiment actively searching for participants?

"According to clinicaltrials.gov, the recruitment phase for this trial has been concluded; it was initially posted on December 1st 2016 and last updated on May 4th 2022. Notwithstanding, 732 other trials are presently in search of suitable participants."

Answered by AI

What sites are offering this scientific trial?

"This trial is hosted at 15 different sites, including Stanford University in Palo Alto California, Children's National Medical Center in Washington District of Columbia, and Boston Children Hospital in Massachusetts."

Answered by AI

Recent research and studies

Pediatric DrugsJournal

Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex

van der Poest Clement, Emma, Floor E. Jansen, Kees P. J. Braun, and Jurriaan M. Peters. 2020. “Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex”. Pediatric Drugs. Springer Science and Business Media LLC. doi:10.1007/s40272-019-00376-0.

clinicaltrials.govStudy

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Martina Bebin 2016. "Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02849457.