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- Zygel (cannabidiol gel) / Paragon Biosci
2024 Update to the Long-term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in the Treatment of Behavioral Symptoms in Children, Adolescents, and Young Adults with Fragile X Syndrome (ZYN2-CL-017) (Crystal D & E; IN-PERSON) - Jul 4, 2024 - Abstract #NFXFFXC2024NFXF_FXC_74;
The results being presented are from the open-label extension (OLE) trial ZYN2-CL-017. The data collected through 31-January-2024 will assess both safety and efficacy in patients entering the OLE from the CONNECT-FX, FAB-C, and RECONNECT trials with forthcoming results and conclusions.
- |||| Zygel (cannabidiol gel) / Paragon Biosci
Trial completion date, Trial primary completion date: RECONNECT: Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults with Fragile X Syndrome (clinicaltrials.gov) - May 7, 2024
P3, N=204, Recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
The data collected through 31-January-2024 will assess both safety and efficacy in patients entering the OLE from the CONNECT-FX, FAB-C, and RECONNECT trials with forthcoming results and conclusions. Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Mar 2024 --> May 2025
- |||| Zygel (cannabidiol gel) / Paragon Biosci
Trial completion date, Trial primary completion date: RECONNECT: Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults with Fragile X Syndrome (clinicaltrials.gov) - Oct 24, 2023
P3, N=204, Recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Mar 2024 --> May 2025 Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Sep 2023 --> Mar 2024
- Zygel (cannabidiol gel) / Zynerba
Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in the Treatment of Behavioral Symptoms in Children and Adolescents With Fragile X Syndrome (ZYN2-CL-017) (Concourse A (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_359;
In patients with complete FMR1 methylation, ZYN002 led to sustained improvement in SA. The results from this trial continue to support the effectiveness of ZYN002 in patients with complete FMR1 methylation.
- | Zygel (cannabidiol gel) / Zynerba
Journal: Development of an UHPLC-MS/MS method to determine cutaneous biodistribution of cannabidiol after topical application of cannabidiol gel assisted by iontophoresis. (Pubmed Central) - Aug 31, 2023
The intra-day and inter-day RSDs of cannabidiol were all <2%. A cryo-sectioning technique combined with the UHPLC-MS/MS method was used to successfully determine cannabidiol levels in a series of very thin skin layers.
- Zygel (cannabidiol gel) / Zynerba
An Open-Label Trial Assessing Short- And Long-Term Tolerability and Efficacy of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE) and Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in the Treatment of Behavioral Symptoms in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017) (Salon 3) - May 9, 2023 - Abstract #ASCP2023ASCP_375;
In patients with complete FMR1 gene methylation, ZYN002 led to sustained improvement in Social Avoidance, a key behavioral symptom of FXS, following initial improvement seen after 12 weeks of double-blind therapy. The results from this OLE trial continue to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation.
- |||| Zygel (cannabidiol gel) / Paragon Biosci
Trial completion date, Trial primary completion date: ZYN2-CL-017: Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents with FXS (clinicaltrials.gov) - May 3, 2023
P2/3, N=450, Enrolling by invitation, Sponsor: Zynerba Pharmaceuticals, Inc.
The results from this OLE trial continue to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation. Trial completion date: May 2027 --> Aug 2027 | Trial primary completion date: May 2027 --> Aug 2027
- || Zygel (cannabidiol gel) / Zynerba
Review, Journal: Medicinal Cannabis for Paediatric Developmental, Behavioural and Mental Health Disorders. (Pubmed Central) - May 2, 2023
Studies of medicinal cannabis are planned or underway for children and/or adolescents with autism, intellectual disability, Tourette's syndrome, anxiety, psychosis, anorexia nervosa and a number of specific neurodevelopmental syndromes. High quality evidence from double-blind placebo-controlled trials is needed to guide clinical practice.
- Zygel (cannabidiol gel) / Zynerba
Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in the Treatment of Behavioral Symptoms in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017) (Salon 4) - Apr 15, 2023 - Abstract #ASCP2023ASCP_242;
In patients with complete FMR1 gene methylation, ZYN002 led to sustained improvement in Social Avoidance, a key behavioral symptom of FXS, following initial improvement seen after 12 weeks of double-blind therapy. The results from this OLE trial continue to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation.
- Zygel (cannabidiol gel) / Zynerba
An Open-Label Trial Assessing Short- And Long-Term Tolerability and Efficacy of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE) (Salon 4) - Apr 15, 2023 - Abstract #ASCP2023ASCP_241;
The results from this OLE trial continue to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation. INSPIRE provides initial evidence suggesting a positive risk
- || Zygel (cannabidiol gel) / Paragon Biosci
Trial completion: INSPIRE: Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (clinicaltrials.gov) - Jan 25, 2023
P1/2, N=20, Completed, Sponsor: Zynerba Pharmaceuticals, Inc.
INSPIRE provides initial evidence suggesting a positive risk Active, not recruiting --> Completed
- || Zygel (cannabidiol gel) / Zynerba
Review, Journal: Role of the endocannabinoid system in fragile X syndrome: potential mechanisms for benefit from cannabidiol treatment. (Pubmed Central) - Jan 10, 2023
Moreover, cannabidiol affects DNA methylation, serotonin 5HT signal transduction, gamma-aminobutyric acid receptor signaling, and dopamine D and D receptor signaling, which may contribute to beneficial effects in patients with FXS. Consistent with these proposed mechanisms of action of cannabidiol in FXS, in the CONNECT-FX trial the transdermal cannabidiol gel, ZYN002, was associated with improvements in measures of social avoidance, irritability, and social interaction, particularly in patients who are most affected, showing ≥90% methylation of the FMR1 gene.
- | Zygel (cannabidiol gel) / Zynerba
Journal: A randomized, controlled trial of ZYN002 cannabidiol transdermal gel in children and adolescents with fragile X syndrome (CONNECT-FX). (Pubmed Central) - Nov 27, 2022
P2/3
Consistent with these proposed mechanisms of action of cannabidiol in FXS, in the CONNECT-FX trial the transdermal cannabidiol gel, ZYN002, was associated with improvements in measures of social avoidance, irritability, and social interaction, particularly in patients who are most affected, showing ≥90% methylation of the FMR1 gene. In CONNECT-FX, ZYN002 was well tolerated in patients with FXS and demonstrated evidence of efficacy with a favorable benefit risk relationship in patients with ≥ 90% methylation of the FMR1 gene, in whom gene silencing is most likely, and the impact of FXS is typically most severe.
- Zygel (cannabidiol gel) / Zynerba
An Open-Label, Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE) (Grand Saguaro) - Oct 31, 2022 - Abstract #ACNP2022ACNP_650;
INSPIRE provides initial evidence suggesting a positive risk–benefit profile for ZYN002 in improving behavioral and anxiety-related symptoms in children and adolescents with 22q when added on top of stable standard of care. Further studies are warranted.
- Zygel (cannabidiol gel) / Zynerba
RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016) (Town and Country Foyer) - Aug 7, 2022 - Abstract #NFXFFXC2022NFXF_FXC_79;
Four of 8 visits will be virtual to reduce family burden. RECONNECT may provide data for the potential approval of ZYN002 as the first treatment of the behavioral symptoms associated with FXS.
- Zygel (cannabidiol gel) / Zynerba
Long-term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017) (Town and Country Foyer) - Aug 7, 2022 - Abstract #NFXFFXC2022NFXF_FXC_78;
ZYN002 was safe and well tolerated over a median of 21 months. ZYN002 led to sustained improvement in Social Avoidance in patients with complete FMR1 gene methylation.
- Zygel (cannabidiol gel) / Zynerba
Zynerba Pharmaceuticals - Development of ZYN002 for the Treatment of Behavioral Symptoms in Fragile X Syndrome: Partnering to advance the care of children and adolescents with Fragile X Syndrome (Town & Country - A) - Aug 7, 2022 - Abstract #NFXFFXC2022NFXF_FXC_43;
- Zygel (cannabidiol gel) / Zynerba
Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017) () - May 6, 2022 - Abstract #SOBP2022SOBP_640;
ZYN002 was safe and well tolerated. ZYN002 led to sustained improvement in Social Avoidance in patients with complete FMR1 methylation.
- Zygel (cannabidiol gel) / Zynerba
Reconnect (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based upon Learnings from Connect-Fx (ZYN2-CL-016) Completed during SARS-COV-2 Pandemic (Palomino Ballroom 4-10) - May 6, 2022 - Abstract #ASCP2022ASCP_72;
The primary endpoint is change from baseline in the ABC‒CFXS Social Avoidance subscale at week 18 in patients with complete methylation of the FMR1 gene (100% by methylation PCR). Key secondary endpoints include change from baseline in ABC-CFXS Irritability, improvement in CaGI-C Social Interactions and FXS-specific CGI-I, and change from baseline in ABC-CFXS Social Avoidance in the full population (complete and partial methylation).
- Zygel (cannabidiol gel) / Zynerba
Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017) (Princess Ballroom F) - May 6, 2022 - Abstract #ASCP2022ASCP_34;
In patients with complete FMR1 gene methylation, ZYN002 led to sustained improvement in Social Avoidance, a key behavioral symptom of FXS, following initial improvement seen after 12 weeks of double-blind therapy. The results from this OLE trial continues to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation.
- | Zygel (cannabidiol gel) / Paragon Biosci
Enrollment closed: INSPIRE: Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (clinicaltrials.gov) - Apr 22, 2022
P1/2, N=20, Active, not recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
The results from this OLE trial continues to support the effectiveness of ZYN002 in patients with complete FMR1 gene methylation. Recruiting --> Active, not recruiting
- |||| Zygel (cannabidiol gel) / Paragon Biosci
Trial completion date, Trial primary completion date: ZYN2-CL-017: Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents with FXS (clinicaltrials.gov) - Apr 14, 2022
P2/3, N=450, Enrolling by invitation, Sponsor: Zynerba Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Trial completion date: Feb 2022 --> May 2027 | Trial primary completion date: Feb 2022 --> May 2027
- | Zygel (cannabidiol gel) / Paragon Biosci
New P1/2 trial: A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Symptoms of Painful Osteoarthritis of the Hand (EUDRACT) - Apr 1, 2022
P1/2, N=20, Not yet recruiting, Sponsor: Avecho Biotechnology
- ||||| Zygel (cannabidiol gel) / Paragon Biosci
Enrollment change: ZYN2-CL-017: Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents with FXS (clinicaltrials.gov) - Jan 27, 2022
P2/3, N=450, Enrolling by invitation, Sponsor: Zynerba Pharmaceuticals, Inc.
Trial completion date: Feb 2022 --> May 2027 | Trial primary completion date: Feb 2022 --> May 2027 N=300 --> 450
- || Zygel (cannabidiol gel) / Zynerba
Clinical, Journal: Safety and Tolerability of Transdermal Cannabidiol Gel in Children With Developmental and Epileptic Encephalopathies: A Nonrandomized Controlled Trial. (Pubmed Central) - Jan 11, 2022
In this study, CBD transdermal gel was safe, well tolerated, and was associated with reductions in FIAS and TCS frequency and disease burden. ClinicalTrials.gov Identifier: ACTRN12618000516280.
- Zygel (cannabidiol gel) / Zynerba
Longer-Term Tolerability And Efficacy Of Zyn002 Cannabidiol Transdermal Gel In Children And Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study (Bright [Zyn2-Cl-030]) () - Dec 18, 2021 - Abstract #AACAP2021AACAP_1081;
No serious or severe AEs or clinically significant changes in laboratory tests or ECGs were reported.Conclusions BRIGHT provides initial evidence suggesting a positive risk-benefit profile for ZYN002 when added on top of stable standard of care in children and adolescents with ASD which was maintained over 38 weeks. Further studies are warranted.
- Zygel (cannabidiol gel) / Zynerba
Reconnect (Zyn2-Cl-033): Design Of A Phase 3 Trial Of Zyn002 Cannabidiol Transdermal Gel In Children And Adolescents With Fragile X Syndrome Based Upon Learnings From Connect-Fx (Zyn2-Cl-016) () - Dec 18, 2021 - Abstract #AACAP2021AACAP_1080;
Four of 8 visits will be virtual to reduce family burden. Results from RECONNECT may provide the data needed to support the potential approval of ZYN002 as the first treatment of the behavioral symptoms associated with FXS.
- || Zygel (cannabidiol gel) / Paragon Biosci
New P1/2 trial: INSPIRE: Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (clinicaltrials.gov) - Dec 7, 2021
P1/2, N=20, Recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
- | Zygel (cannabidiol gel) / Paragon Biosci
New P1/2 trial: A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Symptoms of Painful Osteoarthritis of the Hand (EUDRACT) - Nov 12, 2021
P1/2, N=20, Not yet recruiting, Sponsor: Avecho Biotechnology
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] Longer-term Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Autism Spectrum Disorder: An Open-label Phase 2 Study (BRIGHT [ZYN2-CL-030]) () - Sep 25, 2021 - Abstract #AAPNCE2021AAP_NCE_1656;
BRIGHT provides initial evidence suggesting a positive risk–benefit profile for ZYN002 when added on top of stable standard of care in children/adolescents with ASD which was maintained over 38 weeks. Further studies are warranted.
- |||||| Zygel (cannabidiol gel) / Paragon Biosci
Enrollment open: RECONNECT: Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults with Fragile X Syndrome (clinicaltrials.gov) - Sep 16, 2021
P3, N=204, Recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
Further studies are warranted. Not yet recruiting --> Recruiting
- | Zygel (cannabidiol gel) / Paragon Biosci
New P3 trial: Clinical study of cannabidiol in children, adolescents and young adults with Fragile X syndrome (RECONNECT) (EUDRACT) - Aug 27, 2021
P3, N=204, Not yet recruiting, Sponsor: Zynerba Pharmaceuticals Pty Ltd
- |||||||||| Zygel (cannabidiol gel) / Paragon Biosci
New P3 trial: RECONNECT: Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults with Fragile X Syndrome (clinicaltrials.gov) - Jul 27, 2021
P3, N=204, Not yet recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
- || Zygel (cannabidiol gel) / Zynerba
Petit interlude avant d'attaquer la deuxième partie des ateliers du @FimMpn : Fauré : Sicilienne - Astrig Siranossian (cello) and Jean-François Zygel (... https://t.co/7nsOev1MdB via @YouTube (Twitter) - May 28, 2021
- |||| Zygel (cannabidiol gel) / Paragon Biosci
Enrollment status: ZYN2-CL-017: Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents with FXS (clinicaltrials.gov) - Apr 28, 2021
P2/3, N=300, Enrolling by invitation, Sponsor: Zynerba Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Recruiting --> Enrolling by invitation
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] Meaningful Change Thresholds for the Aberrant Behavior Checklist-Community Fragile X Syndrome (ABC-CFXS) in Children and Adolescents with FXS () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1136;
P2/3
To aid score interpretation, a responder threshold (RT) representing individual patient-level change indicative of treatment benefit was established for three ABC-CFXS subscales (Social Avoidance [SA], Irritability, and Socially Unresponsive/Lethargic [SUL]) measuring the primary and key secondary endpoints in ZYN2-CL-016 (CONNECT-FX), a Phase 3 study of ZYN002 (transdermal cannabidiol) in FXS (NCT03614663)... A change from Baseline to Week 12 of 3, 9, and 5 points on the ABC-CFXS SA, Irritability, and SUL subscales can be interpreted as a meaningful change indicative of treatment benefit for an individual patient with FXS.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] A Pivotal Study of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Fragile X Syndrome [CONNECT-FX (ZYN2-CL-016)] () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1048;
A change from Baseline to Week 12 of 3, 9, and 5 points on the ABC-CFXS SA, Irritability, and SUL subscales can be interpreted as a meaningful change indicative of treatment benefit for an individual patient with FXS. ZYN002 was well tolerated and demonstrated significant improvement in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene, representing a biologically defined population within FXS.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] A Pivotal Study of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Fragile X Syndrome [CONNECT-FX (ZYN2-CL-016)] () - Apr 10, 2021 - Abstract #SOBP2021SOBP_730;
ZYN002 was well tolerated and demonstrated significant improvement in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene, representing a biologically defined population within FXS. ZYN002 was well tolerated and demonstrated significant improvement in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene, representing a biologically defined population within FXS.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] Cannabidiol in Fragile X Syndrome (FXS): Proposed Mechanism of Action (MOA) Translates Into Meaningful Clinical Benefits [CONNECT-FX (ZYN2-CL-016)] () - Apr 10, 2021 - Abstract #SOBP2021SOBP_422;
Thresholds for meaningful treatment benefit for change on the ABC-CFXS were established. ZYN002 provided meaningful improvements in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene supporting the translational MOA of CBD in FXS.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] Cannabidiol in Fragile X Syndrome (FXS): Proposed Mechanism of Action (MOA) Translates Into Meaningful Clinical Benefits [CONNECT-FX (ZYN2-CL-016)] () - Apr 10, 2021 - Abstract #SOBP2021SOBP_73;
Thresholds for meaningful treatment benefit for change on the ABC-CFXS were established. ZYN002 provided meaningful improvements in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene supporting the translational MOA of CBD in FXS.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Developmental and Epileptic Encephalopathies: An Open?label Clinical Trial [BELIEVE (ZYN2-CL-25)] () - Nov 28, 2020 - Abstract #AES2020AES_1150;
This positive benefit‐risk profile supports further study of ZYN002 in this difficult to treat population. Funding: This research was funded by Zynerba Pharmaceuticals, Inc.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] Quality of Life and Caregiver Qualitative Assessments in Children with Developmental and Epileptic Encephalopathies Treated with ZYN002 (CBD) Transdermal Gel: BELIEVE (ZYN2-CL-025) () - Nov 28, 2020 - Abstract #AES2020AES_334;
These findings suggest a positive benefit:risk profile of ZYN002. Additional research is warranted in this difficult to treat population with DEEs.
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] [Bright (ZYN2-CL-030)] ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder and the Indirect Impact on Parent/Caregiver Stress and Family Challenges: An Open-Label Phase 2 Study () - Aug 29, 2020 - Abstract #AACAP2020AACAP_709;
- Zygel (cannabidiol gel) / Zynerba
[VIRTUAL] [Bright (ZYN2-CL-030)] Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study () - Aug 29, 2020 - Abstract #AACAP2020AACAP_708;
- || Zygel (cannabidiol gel) / Zynerba
Clinical, P1/2 data, Journal: A phase 1/2, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome. (Pubmed Central) - Aug 4, 2020
ZYN002 was well tolerated and produced clinically meaningful reductions in anxiety and behavioral symptoms in children and adolescents with FXS. These findings support further study of ZYN002 in a randomized, well-controlled trial for the treatment of behavioral symptoms of FXS.
- ||||||| Zygel (cannabidiol gel) / Paragon Biosci
Trial completion: Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX) (clinicaltrials.gov) - Jul 20, 2020
P2/3, N=212, Completed, Sponsor: Zynerba Pharmaceuticals, Inc.
These findings support further study of ZYN002 in a randomized, well-controlled trial for the treatment of behavioral symptoms of FXS. Active, not recruiting --> Completed
- || Zygel (cannabidiol gel) / Zynerba
#Internacional | Zynerba planea reunirse con la @US_FDA para conocer el camino a seguir para Zygel https://t.co/7sLzrFzjUz (Twitter) - Jul 5, 2020
- | Zygel (cannabidiol gel) / Zynerba
$ZYNE topline data from pivotal CONNECT-FX trial of Zygel in FXS in Q2 (Twitter) - Mar 10, 2020
- ||||| Zygel (cannabidiol gel) / Paragon Biosci
Enrollment closed: Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX) (clinicaltrials.gov) - Feb 5, 2020
P2/3, N=204, Active, not recruiting, Sponsor: Zynerba Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| Zygel (cannabidiol gel) / Zynerba
Clinical: $ZYNE Announces Achievement of Patient Screening Target for Pivotal Trial of Zygel in Fragile X Syndrome. Topline Data from Pivotal CONNECT-FX Study in Q2'20. (Twitter) - Feb 3, 2020