Success Metrics

Clinical Success Rate
85.0%

Based on 17 completed trials

Completion Rate
85%(17/20)
Active Trials
0(0%)
Results Posted
118%(20 trials)
Terminated
3(13%)

Phase Distribution

Ph phase_2
13
57%
Ph phase_3
8
35%
Ph not_applicable
1
4%

Phase Distribution

0

Early Stage

13

Mid Stage

8

Late Stage

Phase Distribution22 total trials
Phase 2Efficacy & side effects
13(59.1%)
Phase 3Large-scale testing
8(36.4%)
N/ANon-phased studies
1(4.5%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

81.0%

17 of 21 finished

Non-Completion Rate

19.0%

4 ended early

Currently Active

0

trials recruiting

Total Trials

23

all time

Status Distribution
Active(1)
Completed(17)
Terminated(4)
Other(1)

Detailed Status

Completed17
Terminated3
unknown1
Withdrawn1
Not yet recruiting1

Development Timeline

Analytics

Development Status

Total Trials
23
Active
0
Success Rate
85.0%
Most Advanced
Phase 3

Trials by Phase

Phase 213 (59.1%)
Phase 38 (36.4%)
N/A1 (4.5%)

Trials by Status

unknown14%
terminated313%
completed1774%
withdrawn14%
not_yet_recruiting14%

Recent Activity

Clinical Trials (23)

Showing 20 of 23 trialsScroll for more
NCT05249556Phase 3

Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old

Not Yet Recruiting
NCT05604170Phase 3

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

Terminated
NCT05323734Phase 3

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

Completed
NCT04391569Phase 3

Randomized Therapy In Status Epilepticus

Completed
NCT00442104Phase 2

Open-label Extension to Protocol 1042-0500

Terminated
NCT05814523Phase 3

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Withdrawn
NCT04678479

Ganaxolone Expanded Access Program Compassionate Use

Unknown
NCT03460756Phase 2

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Completed
NCT03228394Phase 2

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

Completed
NCT02519439Phase 3

A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures

Terminated
NCT03865732Phase 2

Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)

Completed
NCT00441896Phase 2

A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

Completed
NCT03572933Phase 3

Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

Completed
NCT01725152Phase 2

Ganaxolone Treatment in Children With Fragile X Syndrome

Completed
NCT04285346Phase 2

Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)

Completed
NCT02358538Phase 2

Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

Completed
NCT00465517Phase 2

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

Completed
NCT01963208Phase 3

Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Completed
NCT00512317Phase 2

Open-label Extension to Protocol 1042-0600

Completed
NCT01339689Phase 2

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

Completed

Drug Details

Intervention Type
DRUG
Total Trials
23