You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 15, 2025

CLINICAL TRIALS PROFILE FOR ELLENCE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Ellence

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00066807 ↗ Premenopausal Endocrine Responsive Chemotherapy Trial Terminated Breast International Group Phase 3 2003-08-01 The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
NCT00066807 ↗ Premenopausal Endocrine Responsive Chemotherapy Trial Terminated National Cancer Institute (NCI) Phase 3 2003-08-01 The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
NCT00066807 ↗ Premenopausal Endocrine Responsive Chemotherapy Trial Terminated International Breast Cancer Study Group Phase 3 2003-08-01 The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ellence

Condition Name

Condition Name for Ellence
Intervention Trials
Breast Cancer 11
Breast Neoplasms 2
Breast Neoplasm 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Ellence
Intervention Trials
Breast Neoplasms 17
Inflammatory Breast Neoplasms 3
Stomach Neoplasms 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Ellence

Trials by Country

Trials by Country for Ellence
Location Trials
United States 85
Spain 28
Canada 5
Australia 4
Brazil 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Ellence
Location Trials
Texas 6
New York 5
Florida 5
Tennessee 4
Pennsylvania 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Ellence

Clinical Trial Phase

Clinical Trial Phase for Ellence
Clinical Trial Phase Trials
Phase 3 6
Phase 2 11
Phase 1 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Ellence
Clinical Trial Phase Trials
Completed 16
Terminated 2
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Ellence

Sponsor Name

Sponsor Name for Ellence
Sponsor Trials
National Cancer Institute (NCI) 5
Pfizer 4
M.D. Anderson Cancer Center 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Ellence
Sponsor Trials
Industry 25
Other 22
NIH 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projections for Rett Syndrome Treatments: Focus on Anavex 2-73 (Blarcamesine)

Introduction to Rett Syndrome

Rett syndrome is a rare genetic disorder that affects brain development, leading to severe mental and physical disability. It primarily affects girls and is caused by mutations in the MECP2 gene. The search for effective treatments has been ongoing, with several clinical trials and research initiatives in progress.

Current Clinical Trials: Anavex 2-73 (Blarcamesine)

Overview of Anavex 2-73

Anavex 2-73, also known as blarcamesine, is a drug developed by Anavex Life Sciences Corp. It is an activator of the sigma-1 receptor and is administered as a liquid once a day. This drug has received several designations from the FDA, including Fast Track, Rare Pediatric Disease, and Orphan Drug designations for the treatment of Rett syndrome[1].

Phase 2/3 Clinical Trials

In January 2024, Anavex announced the topline results from the EXCELLENCE Phase 2/3 study conducted in girls aged 5-17 with Rett syndrome in Australia, Canada, and the U.K. While the study showed some improvements, it did not reach statistical significance on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ) and failed to meet the co-primary endpoint on the Clinical Global Impression – Improvement scale (CGI-I). However, no new serious adverse events (SAEs) were reported, and over 91% of trial participants continued into the 48-week open-label study[1].

Adult Studies

Anavex has also completed a Phase 3 adult study in Australia and the U.K., with topline results expected soon. Previous studies have shown statistically significant reductions in Rett syndrome severity and continued improvement from the drug compared to placebo patients as measured by the RSBQ over 36 weeks of treatment[1].

Ongoing and Future Trials

The drug is currently being tested in adolescents and adults in the U.S. and Canada. Interim data from the first two patients in the cohort showed no SAEs and clinical improvements in multiple efficacy measures, including motor skills, communication/socialization, autonomic function, and seizures. Patients in both cohorts will be evaluated over the next 60+ months[1].

Market Analysis for Rett Syndrome Treatments

Global Clinical Trials Market

The global clinical trials market, which includes trials for various diseases including Rett syndrome, was valued at USD 80.7 billion in 2023 and is projected to grow at a CAGR of 6.49% from 2024 to 2030. This growth is driven by factors such as the rapid technological evolution, rising prevalence of chronic diseases, and the globalization of clinical trials[3].

Phase III and Phase II Trials

Phase III trials, which account for the largest share of the clinical trials market, are crucial for drugs like Anavex 2-73. These trials involve a large number of subjects and often a longer treatment period, with a median cost of over USD 19.0 million per trial. Phase II trials, which are also significant for oncology-related studies, are expected to witness considerable growth due to the complexity and globalization of these trials[3].

Market Projections for Rett Syndrome Treatments

Potential Market Impact

Given the rare and severe nature of Rett syndrome, any effective treatment is likely to have a significant market impact. The success of Anavex 2-73 in clinical trials could lead to a substantial market presence, especially considering the lack of current treatments for this condition.

Regulatory Support

Favorable regulatory support, such as the FDA's Fast Track and Orphan Drug designations, can accelerate the approval process and enhance market access for drugs like Anavex 2-73. Initiatives like the FDA's Coronavirus Treatment Acceleration Program (CTAP) demonstrate the regulatory environment's potential to support rapid development and approval of critical treatments[3].

Challenges and Opportunities

Recruitment and Monitoring

Clinical trials for rare diseases like Rett syndrome face challenges such as participant recruitment and long-term patient monitoring. However, the high participation rate in Anavex's trials (over 91% continuation into the open-label study) indicates strong patient and caregiver interest in potential treatments[1].

Technological Advancements

Technological advancements, including the use of virtual clinical trials and real-time data submission, can streamline the clinical trial process and reduce costs. These innovations are expected to positively impact the market growth for clinical trials, including those for Rett syndrome treatments[3].

Key Takeaways

  • Clinical Trials Progress: Anavex 2-73 is in advanced clinical trials with promising interim results, particularly in adult and adolescent populations.
  • Market Growth: The global clinical trials market is projected to grow at a CAGR of 6.49% from 2024 to 2030, driven by technological advancements and rising disease prevalence.
  • Regulatory Support: Favorable regulatory designations and initiatives can accelerate the approval and market access for Rett syndrome treatments.
  • Challenges and Opportunities: Participant recruitment and long-term monitoring are challenges, but technological advancements and strong patient interest present opportunities for successful trials.

FAQs

Q: What is Anavex 2-73 (blarcamesine), and how is it administered? A: Anavex 2-73, or blarcamesine, is a sigma-1 receptor activator administered as a liquid once a day. It is being developed for the treatment of Rett syndrome.

Q: What are the current clinical trial results for Anavex 2-73 in Rett syndrome? A: Recent topline results from the EXCELLENCE Phase 2/3 study showed some improvements but did not reach statistical significance on key endpoints. However, no new SAEs were reported, and over 91% of participants continued into the open-label study.

Q: What designations has Anavex 2-73 received from the FDA? A: Anavex 2-73 has received Fast Track, Rare Pediatric Disease, and Orphan Drug designations from the FDA for the treatment of Rett syndrome.

Q: How does the global clinical trials market impact Rett syndrome treatments? A: The growing global clinical trials market, driven by technological advancements and rising disease prevalence, provides a favorable environment for the development and approval of Rett syndrome treatments.

Q: What are the challenges faced by clinical trials for rare diseases like Rett syndrome? A: Clinical trials for rare diseases face challenges such as participant recruitment and long-term patient monitoring, but technological advancements and strong patient interest can mitigate these challenges.

Sources

  1. Rett Research & Clinical Pipeline - International Rett Syndrome Foundation
  2. 2025 Market Planning Guide - Electrical Wholesaling
  3. Clinical Trials Market Size, Share And Growth Report, 2030 - Grand View Research
  4. WITHDRAWN: FDA grants accelerated approval to infigratinib for ... - FDA
  5. What's Next for the 2025 Housing Market? - National Association of REALTORS®
Last updated: 2025-01-03

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.