DAIICHISANKYO PHARMA DEVELOPMENT (DS5565-A-E312)

 An open-label extension study of DS-5565 for 52 weeks in pain associated with Fibromyalgia.

 From widespread burning to localized stabbing, each sufferer experiences the pain associated with fibromyalgia differently. But one thing stays the same – the way that pain impacts on their day-to-day lives.

FIGHTING FIBROMYALGIA PAIN TOGETHER

Although there are treatments available in some countries to manage this debilitating symptom, they don’t work for everyone. So it’s vital we continue to search for new pain relief options. That’s why we’re looking for volunteers to join ALDAY – a medical research study evaluating an investigational drug for fibromyalgia-associated pain.

Why is this study being conducted?

Although there are treatments available to manage fibromyalgia pain, many patients struggle to control their pain or are negatively affected by side effects. So it’s vital we continue to investigate potential new treatments.

What will happen during this study?

Study participation will last about 21 weeks. During the 13-week treatment stage, you’ll take one of the following:
  • The investigational drug
How will my health be monitored?
So we can monitor your health closely, you’ll be asked to record daily information about any pain or sleep trouble you experience. You’ll also attend regular clinic visits (once every 1-2 weeks) for various tests and assessments. These may include questions about health, physical examinations and blood tests.

Some final things to note

All study-related visits, tests and drugs will be provided to participants at no cost (reimbursement for study-related time and travel may also be provided).

The primary objective is to assess the long-term safety of DS-5565 in subjects with FM.

The secondary objectives are:

  • To observe the effects of DS-5565 on average daily pain score (ADPS) and pain-associated sleep interference as assessed by average daily sleep interference score (ADSIS) (both recorded in a diary). Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours
  • To observe the effects of DS-5565 on Patient Global Impression of Change (PGIC)
  • To observe the effects of DS-5565 on depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
  • To observe the effects of DS-5565 on subject quality of life as assessed by the EuroQoL Instrument 5 Domains (EQ-5D) and the Short Form 36 (SF-36)

 

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