DDrare: Database of Drug Development for Rare Diseases

Searched query = "Tuberous sclerosis", "Tuberous sclerosis complex"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = AED; Afinitor; Afinitor 5mg Tablets; Antiepileptic drug (1 to 3 only); Aspirin; Bumetanide; CANNABIDIOL; CBD; CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA.; CBD-Oral Solution, is known as Epidiolex, and is the approved name in the USA.; Calcitriol; Cannabidiol; Cannabidiol (CBD); Certican; Certican 1 mg tablets; Doxycycline; EVEROLIMUS; Everolimus; Everolimus (RAD001); Everolimus 2mg dispersible tablet; Everolimus Oral Product; GWP42003-P; Ganaxolone; Gold; L04AA18; Metformin; Metformin (generic); Metformin hydrochloride; NPC-12G gel; Open label RAD001 (only used for post-extension phase); Petrolatum; Propranolol; RAD001; RAD001 1mg; RAD001 2,5 mg; RAD001 5mg; RAD001 round tablets; RAPAMUNE; Rapamune; Rapamune 1 mg/ml solución oral; Rapamycin; Rapamycin cream, topical, 0.5%, 1.0% w/w; Rapamycin, sirolimus; Rapamycin-calcitriol combination; SIROLIMUS; Simvastatin; Sirolimus; Sirolimus 0.2%; Sirolimus 0.4%; Sirolimus Oral Product; Skincerity; Skincerity plus sirolimus/rapamycin; Skinercity plus sirolimus/rapamycin; Standard of care; TAVT-18 (sirolimus); Tacrolimus; Turmeric; VIGABATRIN; Vigabatrin; Vigabatrin (Sabril); Vigabatrin (sabril); Votubia

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02849457 (ClinicalTrials.gov)	December 2016	13/7/2016	Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex	Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC	Tuberous Sclerosis Complex	Drug: Vigabatrin;Drug: Placebo	Martina Bebin	National Institute of Neurological Disorders and Stroke (NINDS)	Active, not recruiting	N/A	6 Months	All	84	Phase 2	United States
2	EUCTR2013-005528-40-BE (EUCTR)	11/12/2014	17/11/2014	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex - EPISTOP	epilepsy in tuberous sclerosis complex (TSC);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: vigabatrin (sabril) Product Name: vigabatrin INN or Proposed INN: VIGABATRIN	Vrije Universiteit Brussel	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Belgium;Netherlands
3	EUCTR2013-005528-40-NL (EUCTR)	05/12/2014	14/07/2014	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex.	Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex. - EPISTOP	Epilepsy in tuberous sclerosis complex (TSC) MedDRA version: 17.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Vigabatrin (Sabril) Product Name: vigabatrin	The Children's Memorial Health Institute	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Belgium;Netherlands
4	NCT01266291 (ClinicalTrials.gov)	August 2010	22/12/2010	Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients	Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study	Complex Partial Seizures	Drug: vigabatrin	University of Pennsylvania	H. Lundbeck A/S	Terminated	18 Years	N/A	All	1	Phase 4	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02849457
(ClinicalTrials.gov)

December 2016

13/7/2016

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC

Tuberous Sclerosis Complex

Drug: Vigabatrin;Drug: Placebo

Martina Bebin

National Institute of Neurological Disorders and Stroke (NINDS)

Active, not recruiting

N/A

6 Months

All

Phase 2

United States

EUCTR2013-005528-40-BE
(EUCTR)

11/12/2014

17/11/2014

Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex

Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex - EPISTOP

epilepsy in tuberous sclerosis complex (TSC);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: vigabatrin (sabril)
Product Name: vigabatrin
INN or Proposed INN: VIGABATRIN

Vrije Universiteit Brussel

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Belgium;Netherlands

EUCTR2013-005528-40-NL
(EUCTR)

05/12/2014

14/07/2014

Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex.

Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex. - EPISTOP

Epilepsy in tuberous sclerosis complex (TSC)
MedDRA version: 17.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Vigabatrin (Sabril)
Product Name: vigabatrin

The Children's Memorial Health Institute

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Belgium;Netherlands

NCT01266291
(ClinicalTrials.gov)

August 2010

22/12/2010

Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients

Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study

Complex Partial Seizures

Drug: vigabatrin

University of Pennsylvania

H. Lundbeck A/S

Terminated

18 Years

N/A

All

Phase 4

United States