Trials

Principles of Clinical Trials

Clinical trials are designed to evaluate the safety and efficacy of any therapeutic intervention whether it is a drug, device or service used to prevent, detect and/or treat an illness. Indeed, clinical trials constitute a key step in the approval process of any new therapeutic intervention.

Ipsen Pty Ltd ensures that all sponsored clinical trials are conducted in accordance with the current guidelines for Good Clinical Practice (GCP) provided by the International Conference of Harmonisation (ICH). Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The guiding principles of GCP originated in the World Medical Association’s Declaration of Helsinki and its basis was to ensure the protection of human subjects, placing their rights, safety and wellbeing as top priority. In doing so, such standards aim to facilitate the development of safe, effective and high quality medicines.

The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO). In Australia, the Therapeutic Goods Administration (TGA) has adopted the European Union version of GCP which is complemented with the National Statement on Ethical Conduct in Human Research published by the National Health and Medical Research Council (NHMRC). Strict compliance with these standards guarantees that clinical trials conducted by Ipsen Pty Ltd are both ethical and credible.

 

What is a Clinical Trial?

Clinical trials are necessary for the development of new interventions and constitute a series of research studies used to evaluate the safety and efficacy of such interventions. Clinical trials may also be conducted to compare existing interventions, investigate new ways in which an existing intervention can be used and/or investigate the use of combined existing interventions. All clinical trials undergo a rigorous approval process by the appropriate regulatory bodies to ensure they are ethically sound and in accordance with GCP standards.

 

Phases of Clinical Trials

Clinical trials are generally initiated following positive results from extensive pre-clinical testing (ie. laboratory and/or animal testing). Clinical trials are commonly classified into 4 stages, otherwise referred to as phases. Each phase is considered as a separate trial with a separate list of objectives.

 

PHASE I

  • Generally first-in-human trials
  • Generally a small group of healthy volunteers
  • Involves assessing a new intervention in a small group of participants to evaluate its safety and tolerability. In trials involving the use of products, this phase can also be used to determine safe dosage range and identify side effects.

 

PHASE II

  • Involves a larger group of participants
  • In trials involving the use of products, this phase evaluates the efficacy and  further measures the safety of the tested product


PHASE III

  • Involves large groups of participants
  • In trials involving the use of products, this phase further confirms the product’s effectiveness and generally compares it to other commonly used treatments/interventions. Additional safety information is also collected from these trials.

 

PHASE IV

  • Occurs after the new product has been marketed.
  • The main aim of this phase is to collect additional data on the safety, efficacy and benefits of the new intervention in the wider population as well as any side effects associated with long-term use.

 

 

Current Ipsen Pty Ltd Clinical Trials

 

Ipsen-sponsored trials are listed according to therapeutic areas. For further information regarding current clinical trials in Australia, please visit https://www.australianclinicaltrials.gov.au and http://www.anzctr.org.au

 

Further details for each of these trials can also be found on www.clinicaltrials.gov

 

NEUROLOGY

Dystonia

Trial ID# NCT01753349
  Trial Status Registered (active, not recruiting)
  Date Registered 17th December 2012
  Title An international observational prospective study on long-term response to Botulinum toxin type A (BoNT-A) injections in subjects suffering from idiopathic cervical dystonia (CD) – pharmacoeconomic impact.

INTEREST IN CD 2
  Phase Phase IV (observational)
  Indication Cervical Dystonia
 

Spasticity

Trial ID# NCT02454803
  Trial Status Registered (recruiting)
  Date Registered 22nd May 2015
  Title An international, multicenter, observational, prospective, longitudinal cohort study to assess the impact of integrated spasticity management including repeated BoNT-A injections on patient-centred functional goal achievement in adult subjects suffering from upper limb spasticity

ULIS III
  Phase Phase IV (observational)
  Indication Spasticity
 
 

* Last update : Feb 28th 2017